Biomedicines

Editorial

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Open AccessEditorial

Antipsychotics: 70 Years

by Giovanni Lentini and Serge Mignani

Biomedicines 2023, 11(11), 3070; https://doi.org/10.3390/biomedicines11113070 - 16 Nov 2023

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Abstract

To Davide [...] Full article

(This article belongs to the Special Issue Antipsychotics: 70 Years)

Research

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13 pages, 309 KiB

Open AccessArticle

DRD2, DRD3, and HTR2A Single-Nucleotide Polymorphisms Involvement in High Treatment Resistance to Atypical Antipsychotic Drugs

by Antonio Del Casale, Maurizio Simmaco, Martina Nicole Modesti, Clarissa Zocchi, Jan Francesco Arena, Irene Bilotta, Alessandro Alcibiade, Giuseppe Sarli, Lorenzo Cutillo, Giulia Antonelli, Enrico La Spina, Ottavia De Luca, Robert Preissner, Marina Borro, Giovanna Gentile, Paolo Girardi and Maurizio Pompili

Biomedicines 2023, 11(7), 2088; https://doi.org/10.3390/biomedicines11072088 - 24 Jul 2023

Cited by 1 | Viewed by 1311

Abstract

Background: The objective of this study was to investigate the DRD2 rs1800497, rs1799732, rs1801028, DRD3 rs6280, and HTR2A rs6314, rs7997012, and rs6311 single-nucleotide polymorphism (SNP) correlations with resistance to second-generation antipsychotics (SGAs) in a real-world sample of patients with treatment-resistant mental disorders. Methods: [...] Read more.

Background: The objective of this study was to investigate the DRD2 rs1800497, rs1799732, rs1801028, DRD3 rs6280, and HTR2A rs6314, rs7997012, and rs6311 single-nucleotide polymorphism (SNP) correlations with resistance to second-generation antipsychotics (SGAs) in a real-world sample of patients with treatment-resistant mental disorders. Methods: We divided 129 participants into a high treatment resistance (HTR) group (current treatment with two SGAs, or clozapine, or classic neuroleptics for a failure of previous SGAs trials) and a low treatment resistance (LTR) group (current treatment with one atypical antipsychotic). We used Next-Generation Sequencing on DNA isolated from peripheral blood samples to analyze the polymorphisms. We performed logistic regression to search for predictors of HTR membership. Results: A diagnosis of schizophrenia significantly predicted the HTR membership compared to other diagnoses. Other predictors were the DRD3 rs6280 C|T (OR = 22.195) and T|T (OR = 18.47) vs. C|C, HTR2A rs7997012 A|G vs. A|A (OR = 6.859) and vs. G|G (OR = 2.879), and DRD2 rs1799732 I|I vs. D|I (OR = 12.079) genotypes. Conclusions: A diagnosis of schizophrenia and the DRD2 rs1799732, DRD3 rs6280, and HTR2A rs7997012 genotypes can predict high treatment resistance to SGAs. Full article

(This article belongs to the Special Issue Antipsychotics: 70 Years)

14 pages, 1262 KiB

Open AccessArticle

The Influence of Antipsychotic Treatment on the Activity of Abzymes Targeting Myelin and Levels of Inflammation Markers in Patients with Schizophrenia

by Daria A. Kamaeva, Daria V. Kazantseva, Anastasiia S. Boiko, Irina A. Mednova, Liudmila P. Smirnova, Elena G. Kornetova and Svetlana A. Ivanova

Biomedicines 2023, 11(4), 1179; https://doi.org/10.3390/biomedicines11041179 - 14 Apr 2023

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Abstract

Catalytic antibodies, or abzymes, are capable of not only binding but also hydrolyzing various proteins. Previously, an increase in the level of myelin basic protein (MBP)-hydrolyzing activity of antibodies was shown in patients with a number of neurological and mental disorders, including schizophrenia. [...] Read more.

Catalytic antibodies, or abzymes, are capable of not only binding but also hydrolyzing various proteins. Previously, an increase in the level of myelin basic protein (MBP)-hydrolyzing activity of antibodies was shown in patients with a number of neurological and mental disorders, including schizophrenia. Furthermore, antipsychotic therapy is known to induce a change in cytokine levels in patients with schizophrenia, which affects regulation of the immune response and inflammatory status. This study investigated the influence of typical and atypical antipsychotics on catalytic antibody activity and the 10 major pro- and anti-inflammatory serum cytokine levels. The study included 40 patients with schizophrenia: 15 treated with first-generation antipsychotics and 25 treated with atypical antipsychotics for 6 weeks. It was found that treatment with atypical antipsychotics changed the levels of some pro-inflammatory cytokines. Antipsychotic therapy also caused a significant decrease in MBP-hydrolyzing activity in patients with schizophrenia (p = 0.0002), and associations of catalytic activity with interleukins were observed. Full article

(This article belongs to the Special Issue Antipsychotics: 70 Years)

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11 pages, 267 KiB

Open AccessArticle

Clozapine in Treatment-Resistant Schizophrenia and Its Augmentation with Electroconvulsive Therapy in Ultra-Treatment-Resistant Schizophrenia

by Vjekoslav Peitl, Antonia Puljić, Mislav Škrobo, Sergej Nadalin, Lidija Fumić Dunkić and Dalibor Karlović

Biomedicines 2023, 11(4), 1072; https://doi.org/10.3390/biomedicines11041072 - 02 Apr 2023

Cited by 2 | Viewed by 3937

Abstract

Clozapine is considered the gold standard for patients with treatment-resistant schizophrenia (TRS) who have previously tried other antipsychotics at adequate doses (two or more, with at least one being atypical). However, despite optimal treatment, a subgroup of TRS patients with what is known [...] Read more.

Clozapine is considered the gold standard for patients with treatment-resistant schizophrenia (TRS) who have previously tried other antipsychotics at adequate doses (two or more, with at least one being atypical). However, despite optimal treatment, a subgroup of TRS patients with what is known as ultra-treatment-resistant schizophrenia (UTRS) fails to respond to clozapine, which occurs in 40–70% of cases. The most common approach to manage UTRS involves augmenting clozapine with pharmacological or non-pharmacological interventions, with a growing body of evidence that supports the use of electroconvulsive therapy (ECT) as an augmenter. This prospective non-randomized 8-week study, which followed the TRIPP Working Group guidelines and is one of few that separate TRS from UTRS, aimed to evaluate the effectiveness of clozapine in TRS patients and the efficacy of ECT augmentation of clozapine in UTRS patients. Patients with TRS were assigned to receive clozapine alone (clozapine group), whereas UTRS patients received bilateral ECT in addition to their current medication regimen (ECT plus clozapine group). The severity of symptoms was evaluated using the Clinical Global Impression Scale (CGI) and Positive and Negative Syndrome Scale (PANSS) at baseline and at the end of the 8-week trial. Both treatment approaches resulted in improved CGI and PANSS scores. The results suggest that both clozapine and ECT are effective treatment options for patients with TRS and UTRS, respectively, and that adherence to guidelines should provide a better frame for future clinical studies. Full article

(This article belongs to the Special Issue Antipsychotics: 70 Years)

18 pages, 490 KiB

Open AccessArticle

High Rate of Discontinuation during Long-Acting Injectable Antipsychotic Treatment in Patients with Psychotic Disorders

by Anna Maria Auxilia, Massimiliano Buoli, Alice Caldiroli, Greta Silvia Carnevali, Agnese Tringali, Roberto Nava, Massimo Clerici and Enrico Capuzzi

Biomedicines 2023, 11(2), 314; https://doi.org/10.3390/biomedicines11020314 - 22 Jan 2023

Cited by 5 | Viewed by 2391

Abstract

Treatment discontinuation is a major challenge in routine clinical settings. Despite poor adherence to antipsychotic medication, long acting injectable (LAI) formulations are an underutilized option in psychotic disorders. Recently, an earlier and broader use of LAIs has been emphasized. However, few studies have [...] Read more.

Treatment discontinuation is a major challenge in routine clinical settings. Despite poor adherence to antipsychotic medication, long acting injectable (LAI) formulations are an underutilized option in psychotic disorders. Recently, an earlier and broader use of LAIs has been emphasized. However, few studies have evaluated the factors associated with LAI antipsychotic discontinuation in ordinary clinical practice. The main purpose of the present study was, therefore, to identify the factors associated with LAI discontinuation in a real-world setting. Patients in treatment with LAI antipsychotics were recruited. A Cox regression analysis was applied considering a 12-month follow-up period. Moreover, a Kaplan-Meier survival analysis was applied to compare the single treatment LAI antipsychotic groups in terms of time to discontinuation. Our analysis showed an LAI discontinuation rate at 12 months, corresponding to 28.8%, with olanzapine and aripiprazole having a longer time to discontinuation compared to zuclopenthixol. The results of the present study can help clinicians with their choice of LAI antipsychotic according to patients’ characteristics and in a context of precision medicine. Increasing knowledge about factors affecting discontinuation of LAI antipsychotics can improve the prescribing practices of these compounds. Individualized approaches may ameliorate long-term patients’ treatment adherence, thus preventing the long-term disability caused by psychotic disorders. Full article

(This article belongs to the Special Issue Antipsychotics: 70 Years)

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13 pages, 314 KiB

Open AccessArticle

Glucose and Lipid Profiles Predict Anthropometric Changes in Drug-Naïve Adolescents Starting Treatment with Risperidone or Sertraline: A Pilot Study

by Emilia Matera, Gloria Cristofano, Flora Furente, Lucia Marzulli, Martina Tarantini, Lucia Margari, Francesco Maria Piarulli, Andrea De Giacomo and Maria Giuseppina Petruzzelli

Biomedicines 2023, 11(1), 48; https://doi.org/10.3390/biomedicines11010048 - 25 Dec 2022

Cited by 3 | Viewed by 1668

Abstract

Psychiatric disorders are associated with cardiometabolic diseases, partly due to adverse drug effects with individual risk variabilities. Risperidone and sertraline are widely used for youths. Although they may be exposed to anthropometric changes, few data about this population exist. We evaluated the correlation [...] Read more.

Psychiatric disorders are associated with cardiometabolic diseases, partly due to adverse drug effects with individual risk variabilities. Risperidone and sertraline are widely used for youths. Although they may be exposed to anthropometric changes, few data about this population exist. We evaluated the correlation between several blood parameters and body changes in a very small group of drug-naïve adolescents who had started risperidone or sertraline. We examined weight, waist circumference (WC), WC/height ratio and body mass index (BMI) at baseline (T0) and after at least three months of therapy (T1), and blood glucose and lipid profiles at T0. Here, we show significant increases in several anthropometric parameters in both groups, a negative correlation between HDL and ΔWC in the risperidone group and positive correlations between insulin and ΔBMI and between HOMA-IR and ΔBMI in the sertraline group. Despite the sample size, these results are important because it is difficult to study adolescents who are long-term-compliant with psychotropic drugs. This pilot study supports the importance of future large-scale investigations to understand the metabolic risk profiles of psychotropic drugs, their individual vulnerabilities and their underlying mechanisms. Simultaneous guideline-based psychiatric and metabolic interventions should be part of daily practice. Full article

(This article belongs to the Special Issue Antipsychotics: 70 Years)

13 pages, 1183 KiB

Open AccessArticle

The Use of Second-Generation Antipsychotics in Patients with Severe Schizophrenia in the Real World: The Role of the Route of Administration and Dosage—A 5-Year Follow-Up

by Juan J. Fernández-Miranda, Silvia Díaz-Fernández and Francisco López-Muñoz

Biomedicines 2023, 11(1), 42; https://doi.org/10.3390/biomedicines11010042 - 24 Dec 2022

Cited by 4 | Viewed by 2154

Abstract

To assess the impact of the route of administration and doses of second-generation antipsychotics (SGAs) on treatment adherence, hospital admissions, and suicidal behaviour in patients with severe schizophrenia (Clinical Global Impression–Severity–CGI-S ≥ 5), we implemented an observational 5-year follow-up study. A total of [...] Read more.

To assess the impact of the route of administration and doses of second-generation antipsychotics (SGAs) on treatment adherence, hospital admissions, and suicidal behaviour in patients with severe schizophrenia (Clinical Global Impression–Severity–CGI-S ≥ 5), we implemented an observational 5-year follow-up study. A total of 37.5% of the patients on oral antipsychotics (Aps) and 11.5% of those on long-acting injectables (LAIs) abandoned the treatment (p < 0.001). There were no differences in treatment discontinuation between the LAI-AP standard and high-dose groups. A total of 28.1% of the patients on oral Aps had at least one hospitalisation, as well as 13.1% of patients on LAIs (p < 0.001). There were fewer hospitalisations of patients on LAIs in the high-dose group (p < 0.05). Suicide attempts were recorded for 18% of patients on oral Aps but only for 4.6% of patients on LAIs (p < 0.001). No differences were found between the dosage groups on LAIs. Tolerability was good for all Aps and somewhat better for LAIs than oral Aps in terms of side effects (p < 0.05). There were no differences between the standard and high-dose groups. More patients discontinued treatment due to side effects in the oral AP group (p < 0.01). LAI SGA treatment was more effective than oral AP in terms of adherence and treatment outcomes for managing people with severe schizophrenia. Moreover, significant improvements were found that favour high-dose LAI SGA treatment for some of these patients. This study highlights the need to consider LAI antipsychotics and high-dose strategies for patients with severe schizophrenia. Full article

(This article belongs to the Special Issue Antipsychotics: 70 Years)

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13 pages, 970 KiB

Open AccessArticle

The Effect of Antipsychotics and Their Combinations with Other Psychotropic Drugs on Electrocardiogram Intervals Other Than QTc among Jordanian Adult Outpatients

by Nailya Bulatova, Noor Altaher, Radwan BaniMustafa, Akram Al-Saleh, Haya Yasin, Mohammed Zawiah, Hala Khalefah, Mokhtar Ghilan, Ala’a Al-Lahham, Mohummad Hudaib, Batoul AlKhawaldeh and Mahmoud Nasr

Biomedicines 2023, 11(1), 13; https://doi.org/10.3390/biomedicines11010013 - 22 Dec 2022

Cited by 1 | Viewed by 2360

Abstract

The ECG changes produced by antipsychotics and other psychotropic medications are studied mostly regarding QTc interval prolongation. This study aimed to investigate ECG changes beyond long QTc interval produced by psychotropic medications. A cross-sectional study was conducted to assess the effect of these [...] Read more.

The ECG changes produced by antipsychotics and other psychotropic medications are studied mostly regarding QTc interval prolongation. This study aimed to investigate ECG changes beyond long QTc interval produced by psychotropic medications. A cross-sectional study was conducted to assess the effect of these agents on RR, PR, TpTe intervals and TpTe/QT ratio among Jordanian outpatients. The RR interval was significantly shorter among patients on TCAs versus those not receiving TCAs and among patients on polytherapy versus those on monotherapy (p < 0.05 for both comparisons), when adjusted for age, gender, BMI, caffeine intake, smoking, presence of diabetes mellitus, cardiovascular disease and medications known to produce heart rate changes. Positive correlations were found between the PR interval and age in patients treated with SGAs, SSRIs, citalopram, polytherapy and in the total sample (p < 0.01 for all). Inverse correlations were found between the RR interval and the number of psychotropic medications among patients treated with SSRIs and in the whole study sample (p < 0.01 for both). In conclusion, various ECG changes beyond QTc interval prolongation are observed in patients on antipsychotics and other psychotropic medications, in those on polytherapy. It is recommended to obtain an ECG before starting patients on psychotropic drugs known to produce electrocardiographic changes and their combinations. Full article

(This article belongs to the Special Issue Antipsychotics: 70 Years)

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13 pages, 1079 KiB

Open AccessArticle

High Risk, High Dose?—Pharmacotherapeutic Prescription Patterns of Offender and Non-Offender Patients with Schizophrenia Spectrum Disorder

by Lena Machetanz, Moritz Philipp Günther, Steffen Lau and Johannes Kirchebner

Biomedicines 2022, 10(12), 3243; https://doi.org/10.3390/biomedicines10123243 - 13 Dec 2022

Cited by 3 | Viewed by 1219

Abstract

Compared to acute or community settings, forensic psychiatric settings, in general, have been reported to make greater use of antipsychotic polypharmacy and/or high dose pharmacotherapy, including overdosing. However, there is a scarcity of research specifically on offender patients with schizophrenia spectrum disorders (SSD), [...] Read more.

Compared to acute or community settings, forensic psychiatric settings, in general, have been reported to make greater use of antipsychotic polypharmacy and/or high dose pharmacotherapy, including overdosing. However, there is a scarcity of research specifically on offender patients with schizophrenia spectrum disorders (SSD), although they make up a large proportion of forensic psychiatric patients. Our study, therefore, aimed at evaluating prescription patterns in offender patients compared to non-offender patients with SSD. After initial statistical analysis with null-hypothesis significance testing, we evaluated the interplay of the significant variables and ranked them in accordance with their predictive power through application of supervised machine learning algorithms. While offender patients received higher doses of antipsychotics, non-offender patients were more likely to receive polypharmacologic treatment as well as additional antidepressants and benzodiazepines. To the authors’ knowledge, this is the first study to evaluate a homogenous group of offender patients with SSD in comparison to non-offender controls regarding patterns of antipsychotic and other psychopharmacologic prescription patterns. Full article

(This article belongs to the Special Issue Antipsychotics: 70 Years)

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16 pages, 666 KiB

Open AccessArticle

SLC6A3, HTR2C and HTR6 Gene Polymorphisms and the Risk of Haloperidol-Induced Parkinsonism

by Gordana Nedic Erjavec, Mirko Grubor, Maja Zivkovic, Nada Bozina, Marina Sagud, Matea Nikolac Perkovic, Alma Mihaljevic-Peles, Nela Pivac and Dubravka Svob Strac

Biomedicines 2022, 10(12), 3237; https://doi.org/10.3390/biomedicines10123237 - 13 Dec 2022

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Abstract

Antipsychotic-induced parkinsonism (AIP) is the most common type of extrapyramidal side effect (EPS), caused by the blockage of dopamine receptors. Since dopamine availability might influence the AIP risk, the dopamine transporter (DAT) and serotonin receptors (5-HTRs), which modulate the dopamine release, may be [...] Read more.

Antipsychotic-induced parkinsonism (AIP) is the most common type of extrapyramidal side effect (EPS), caused by the blockage of dopamine receptors. Since dopamine availability might influence the AIP risk, the dopamine transporter (DAT) and serotonin receptors (5-HTRs), which modulate the dopamine release, may be also involved in the AIP development. As some of the individual differences in the susceptibility to AIP might be due to the genetic background, this study aimed to examine the associations of SLC6A3, HTR2C and HTR6 gene polymorphisms with AIP in haloperidol-treated schizophrenia patients. The Extrapyramidal Symptom Rating Scale (ESRS) was used to evaluate AIP as a separate entity. Genotyping was performed using a PCR, following the extraction of blood DNA. The results revealed significant associations between HTR6 rs1805054 polymorphism and haloperidol-induced tremor and rigidity. Additionally, the findings indicated a combined effect of HTR6 T and SLC6A3 9R alleles on AIP, with their combination associated with significantly lower scores of ESRS subscale II for parkinsonism, ESRS-based tremor or hyperkinesia and ESRS subscales VI and VIII. These genetic predictors of AIP could be helpful in better understanding its pathophysiology, recognizing the individuals at risk of developing AIP and offering personalized therapeutic strategies for the patients suffering from this EPS. Full article

(This article belongs to the Special Issue Antipsychotics: 70 Years)

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14 pages, 991 KiB

Open AccessArticle

Prescriptions of Antipsychotics in Younger and Older Geriatric Patients with Polypharmacy, Their Safety, and the Impact of a Pharmaceutical-Medical Dialogue on Antipsychotic Use

by Eva-Maria Gebauer and Albert Lukas

Biomedicines 2022, 10(12), 3127; https://doi.org/10.3390/biomedicines10123127 - 04 Dec 2022

Cited by 2 | Viewed by 1530

Abstract

Geriatric patients are a particularly vulnerable and, at the same time, very heterogeneous group due to their multimorbidity and polypharmacy. Antipsychotics are often prescribed in their complex drug regimens, whereby the prescription of antipsychotics is not without controversy. To date, questions remain as [...] Read more.

Geriatric patients are a particularly vulnerable and, at the same time, very heterogeneous group due to their multimorbidity and polypharmacy. Antipsychotics are often prescribed in their complex drug regimens, whereby the prescription of antipsychotics is not without controversy. To date, questions remain as to whether there are differences in the prescribing pattern, safety, and impact of a consultant pharmacist regarding antipsychotic use between younger and older geriatric patients in the heterogenic geriatric group. This monocentric study of 744 patients was based on the analysis of routine data collected from January 2018 to June 2020 in a geriatric department during a weekly pharmaceutical and medical consultation. The frequency of the prescription of antipsychotics in our study was 30.7%. Regarding antipsychotic safety and/or adverse drug reaction (ADR) antipsychotics, only a difference in terms of overuse in younger geriatric patients was found. The binary logistic regression analyses of geriatric patients with antipsychotics revealed that ADRs and drug–drug interactions (DDIs) were particularly related to the number of medications prescribed. The higher the number of prescribed drugs, the higher the risk of ADRs and DDIs. In 26.7% of geriatric patients on antipsychotics, the pharmacist made recommendations that were almost exclusively implemented by the physician, with no difference made between the two age groups. The prescriptions of antipsychotics in geriatric patients with polypharmacy, their safety, and the impact of a pharmaceutical-medical dialogue on the use of antipsychotics seem comparable between younger and older geriatric patients in the geriatric setting. Antipsychotics should always be critically considered and used cautiously, whereby a regular pharmaceutical-medical dialogue is recommended in geriatric settings. Full article

(This article belongs to the Special Issue Antipsychotics: 70 Years)

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10 pages, 1164 KiB

Open AccessArticle

Changes in Alprazolam Metabolism by CYP3A43 Mutants

by Jie Zhao, Sijie Liu, Clemens Alexander Wolf, Gerhard Wolber, Maria Kristina Parr and Matthias Bureik

Biomedicines 2022, 10(12), 3022; https://doi.org/10.3390/biomedicines10123022 - 23 Nov 2022

Cited by 3 | Viewed by 2090

Abstract

Alprazolam is a triazolobenzodiazepine which is most commonly used in the short-term management of anxiety disorders, often in combination with antipsychotics. The four human members of the CYP3A subfamily are mainly responsible for its metabolism, which yields the main metabolites 4-hydroxyalprazolam and α-hydroxyalprazolam. [...] Read more.

Alprazolam is a triazolobenzodiazepine which is most commonly used in the short-term management of anxiety disorders, often in combination with antipsychotics. The four human members of the CYP3A subfamily are mainly responsible for its metabolism, which yields the main metabolites 4-hydroxyalprazolam and α-hydroxyalprazolam. We performed a comparison of alprazolam metabolism by all four CYP3A enzymes upon recombinant expression in the fission yeast Schizosaccharomyces pombe. CYP3A4 and CYP3A5 show the highest 4-hydroxyalprazolam production rates, while CYP3A5 alone is the major producer of α-hydroxyalprazolam. For both metabolites, CYP3A7 and CYP3A43 show lower activities. Computational simulations rationalize the difference in preferred oxidation sites observed between the exemplary enzymes CYP3A5 and CYP3A43. Investigations of the alprazolam metabolites formed by three previously described CYP3A43 mutants (L293P, T409R, and P340A) unexpectedly revealed that they produce 4-hydroxy-, but not α-hydroxyalprazolam. Instead, they all also make a different metabolite, which is 5-N-O alprazolam. With respect to 4-hydroxyalprazolam, the mutants showed fourfold (T409R) to sixfold (L293P and P340A) higher production rates compared to the wild-type (CYP3A43.1). In the case of 5-N-O alprazolam, the production rates were similar for the three mutants, while no formation of this metabolite was found in the wild-type incubation. Full article

(This article belongs to the Special Issue Antipsychotics: 70 Years)

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15 pages, 1538 KiB

Open AccessArticle

Antipsychotic Abuse, Dependence, and Withdrawal in the Pediatric Population: A Real-World Disproportionality Analysis

by Diane Merino, Alexandre O. Gérard, Alexandre Destere, Florence Askenazy, Milou-Daniel Drici and Susanne Thümmler

Biomedicines 2022, 10(11), 2972; https://doi.org/10.3390/biomedicines10112972 - 18 Nov 2022

Cited by 2 | Viewed by 4200

Abstract

Antipsychotic drugs (APs) aim to treat schizophrenia, bipolar mania, and behavioral symptoms. In child psychiatry, despite limited evidence regarding their efficacy and safety, APs are increasingly subject to off-label use. Studies investigating addictology-related symptoms in young people being scarce, we aimed to characterize [...] Read more.

Antipsychotic drugs (APs) aim to treat schizophrenia, bipolar mania, and behavioral symptoms. In child psychiatry, despite limited evidence regarding their efficacy and safety, APs are increasingly subject to off-label use. Studies investigating addictology-related symptoms in young people being scarce, we aimed to characterize the different patterns of AP misuse and withdrawal in children and adolescents relying on the WHO pharmacovigilance database (VigiBase^®, Uppsala Monitoring Centre, Sweden). Using the standardized MedDRA Query ‘drug abuse, dependence and withdrawal’, disproportionality for each AP was assessed with the reporting odds ratio and the information component. A signal was detected when the lower end of the 95% confidence interval of the information component was positive. Results revealed mainly withdrawal symptoms in infants (under 2 years), intentional misuse in children (2 to 11 years), and abuse in adolescents (12 to 17 years). Olanzapine, risperidone, aripiprazole, and quetiapine were disproportionately reported in all age groups, with quetiapine being subject to a specific abuse signal in adolescents. Thus, in adolescents, the evocation of possible recreational consumption may lead to addiction-appropriate care. Further, in young patients with a history of AP treatment, a careful anamnesis may allow one to identify misuse and its role in the case of new-onset symptoms. Full article

(This article belongs to the Special Issue Antipsychotics: 70 Years)

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22 pages, 3030 KiB

Open AccessArticle

The Impact of Antipsychotic Treatment on Neurological Soft Signs in Patients with Predominantly Negative Symptoms of Schizophrenia

by Cristian Petrescu, Ioana R. Papacocea, Crisanda Vilciu, Oana A. Mihalache, Diana M. Vlad, Gabriela Marian, Brindusa E. Focseneanu, Cristian T. Sima, Constantin A. Ciobanu, Sorin Riga and Adela M. Ciobanu

Biomedicines 2022, 10(11), 2939; https://doi.org/10.3390/biomedicines10112939 - 15 Nov 2022

Cited by 4 | Viewed by 1908

Abstract

Schizophrenia is a complex and incompletely elucidated pathology that affects sensorimotor function and also produces numerous therapeutic challenges. The aims of this cross-sectional study were to identify the profile of neurological soft signs (NSS) in patients with predominantly negative symptoms of schizophrenia (PNS) [...] Read more.

Schizophrenia is a complex and incompletely elucidated pathology that affects sensorimotor function and also produces numerous therapeutic challenges. The aims of this cross-sectional study were to identify the profile of neurological soft signs (NSS) in patients with predominantly negative symptoms of schizophrenia (PNS) compared with patients with schizophrenia who do not present a predominance of negative symptoms (NPNS) and also to objectify the impact of treatment on the neurological function of these patients. Ninety-nine (n = 99; 56 females and 43 males) patients diagnosed with schizophrenia according to DSM-V were included; these patients were undergoing antipsychotic (4 typical antipsychotics, 86 atypical antipsychotics, and 9 combinations of two atypical antipsychotics) or anticholinergic treatment (24 out of 99) at the time of evaluation, and the PANSS was used to identify the patients with predominantly negative symptoms (n = 39), the Neurological Evaluation Scale (NES) was used for the evaluation of neurological soft signs (NSS), and the SAS was used for the objectification of the extrapyramidal side effects induced by the neuroleptic treatment, which was converted to chlorpromazine equivalents (CPZE). The study’s main finding was that, although the daily dose of CPZE did not represent a statistically significant variable, in terms of neurological soft signs, patients with PNS had higher rates of NSS. Full article

(This article belongs to the Special Issue Antipsychotics: 70 Years)

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Review

Jump to: Editorial, Research, Other

20 pages, 339 KiB

Open AccessReview

Unlocking the Therapeutic Potential of Ulotaront as a Trace Amine-Associated Receptor 1 Agonist for Neuropsychiatric Disorders

by Savelii R. Kuvarzin, Ilya Sukhanov, Kirill Onokhin, Konstantin Zakharov and Raul R. Gainetdinov

Biomedicines 2023, 11(7), 1977; https://doi.org/10.3390/biomedicines11071977 - 13 Jul 2023

Cited by 2 | Viewed by 1881

Abstract

All antipsychotics currently used in clinic block D2 dopamine receptors. Trace amine-associated receptor 1 is emerging as a new therapeutic target for schizophrenia and several other neuropsychiatric disorders. SEP-363856 (International Nonproprietary Name: Ulotaront) is an investigational antipsychotic drug with a novel mechanism of [...] Read more.

All antipsychotics currently used in clinic block D2 dopamine receptors. Trace amine-associated receptor 1 is emerging as a new therapeutic target for schizophrenia and several other neuropsychiatric disorders. SEP-363856 (International Nonproprietary Name: Ulotaront) is an investigational antipsychotic drug with a novel mechanism of action that does not involve antagonism of dopamine D2 receptors. Ulotaront is an agonist of trace amine-associated receptor 1 and serotonin 5-HT1A receptors, but can modulate dopamine neurotransmission indirectly. In 2019, the United States Food and Drug Administration granted Breakthrough Therapy Designation for ulotaront for the treatment of schizophrenia. Phase 2 clinical studies indicated that ulotaront can reduce both positive and negative symptoms of schizophrenia without causing the extrapyramidal or metabolic side effects that are inherent to most currently used antipsychotics. At present, it is in phase 3 clinical development for the treatment of schizophrenia and is expected to be introduced into clinical practice in 2023–2024. Clinical studies evaluating the potential efficacy of ulotaront in Parkinson’s disease psychosis, generalized anxiety disorder, and major depressive disorder have also been started. The aim of this scoping review is to summarize all currently available preclinical and clinical evidence on the utility of ulotaront in the treatment of schizophrenia. Here, we show the main characteristics and distinctive features of this drug. Perspectives and limitations on the potential use of ulotaront in the pharmacotherapy of several other neuropsychiatric disorders are also discussed. Full article

(This article belongs to the Special Issue Antipsychotics: 70 Years)

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31 pages, 928 KiB

Open AccessReview

Efficacy of Serotonin and Dopamine Activity Modulators in the Treatment of Negative Symptoms in Schizophrenia: A Rapid Review

by Claudio Brasso, Gianluca Colli, Rodolfo Sgro, Silvio Bellino, Paola Bozzatello, Cristiana Montemagni, Vincenzo Villari and Paola Rocca

Biomedicines 2023, 11(3), 921; https://doi.org/10.3390/biomedicines11030921 - 16 Mar 2023

Cited by 4 | Viewed by 2681

Abstract

Schizophrenia is among the fifteen most disabling diseases worldwide. Negative symptoms (NS) are highly prevalent in schizophrenia, negatively affect the functional outcome of the disorder, and their treatment is difficult and rarely specifically investigated. Serotonin-dopamine activity modulators (SDAMs), of which aripiprazole, cariprazine, brexpiprazole, [...] Read more.

Schizophrenia is among the fifteen most disabling diseases worldwide. Negative symptoms (NS) are highly prevalent in schizophrenia, negatively affect the functional outcome of the disorder, and their treatment is difficult and rarely specifically investigated. Serotonin-dopamine activity modulators (SDAMs), of which aripiprazole, cariprazine, brexpiprazole, and lumateperone were approved for schizophrenia treatment, represent a possible therapy to reduce NS. The aim of this rapid review is to summarize the evidence on this topic to make it readily available for psychiatrists treating NS and for further research. We searched the PubMed database for original studies using SDAM, aripiprazole, cariprazine, brexpiprazole, lumateperone, schizophrenia, and NS as keywords. We included four mega-analyses, eight meta-analyses, two post hoc analyses, and 20 clinical trials. Aripiprazole, cariprazine, and brexpiprazole were more effective than placebo in reducing NS. Only six studies compared SDAMs with other classes of antipsychotics, demonstrating a superiority in the treatment of NS mainly for cariprazine. The lack of specific research and various methodological issues, related to the study population and the assessment of NS, may have led to these partial results. Here, we highlight the need to conduct new methodologically robust investigations with head-to-head treatment comparisons and long-term observational studies on homogeneous groups of patients evaluating persistent NS with first- and second-generation scales, namely the Brief Negative Symptom Scale and the Clinical Assessment Interview for Negative Symptoms. This rapid review can expand research on NS therapeutic strategies in schizophrenia, which is fundamental for the long-term improvement of patients’ quality of life. Full article

(This article belongs to the Special Issue Antipsychotics: 70 Years)

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18 pages, 2123 KiB

Open AccessReview

Endocannabinoid Degradation Enzyme Inhibitors as Potential Antipsychotics: A Medicinal Chemistry Perspective

by Giuseppe Felice Mangiatordi, Maria Maddalena Cavalluzzi, Pietro Delre, Giuseppe Lamanna, Maria Cristina Lumuscio, Michele Saviano, Jean-Pierre Majoral, Serge Mignani, Andrea Duranti and Giovanni Lentini

Biomedicines 2023, 11(2), 469; https://doi.org/10.3390/biomedicines11020469 - 06 Feb 2023

Cited by 2 | Viewed by 1948

Abstract

The endocannabinoid system (ECS) plays a very important role in numerous physiological and pharmacological processes, such as those related to the central nervous system (CNS), including learning, memory, emotional processing, as well pain control, inflammatory and immune response, and as a biomarker in [...] Read more.

The endocannabinoid system (ECS) plays a very important role in numerous physiological and pharmacological processes, such as those related to the central nervous system (CNS), including learning, memory, emotional processing, as well pain control, inflammatory and immune response, and as a biomarker in certain psychiatric disorders. Unfortunately, the half-life of the natural ligands responsible for these effects is very short. This perspective describes the potential role of the inhibitors of the enzymes fatty acid amide hydrolase (FAAH) and monoacylglycerol lipase (MGL), which are mainly responsible for the degradation of endogenous ligands in psychic disorders and related pathologies. The examination was carried out considering both the impact that the classical exogenous ligands such as Δ⁹-tetrahydrocannabinol (THC) and (−)-trans-cannabidiol (CBD) have on the ECS and through an analysis focused on the possibility of predicting the potential toxicity of the inhibitors before they are subjected to clinical studies. In particular, cardiotoxicity (hERG liability), probably the worst early adverse reaction studied during clinical studies focused on acute toxicity, was predicted, and some of the most used and robust metrics available were considered to select which of the analyzed compounds could be repositioned as possible oral antipsychotics. Full article

(This article belongs to the Special Issue Antipsychotics: 70 Years)

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18 pages, 1645 KiB

Open AccessEditor’s ChoiceReview

Seventy Years of Antipsychotic Development: A Critical Review

by Mujeeb U. Shad

Biomedicines 2023, 11(1), 130; https://doi.org/10.3390/biomedicines11010130 - 04 Jan 2023

Cited by 7 | Viewed by 4337

Abstract

Since the mid-1950s discovery of the first effective antipsychotic medications (APM), we have only been able to improve the tolerability but not the overall efficacy of currently available APMs, as reflected by effectiveness trials in Europe and the United States. This inability to [...] Read more.

Since the mid-1950s discovery of the first effective antipsychotic medications (APM), we have only been able to improve the tolerability but not the overall efficacy of currently available APMs, as reflected by effectiveness trials in Europe and the United States. This inability to develop more effective APMs is attributable to multiple factors, including failure to create and use assessment tools to assess core symptom domains in schizophrenia, move beyond the dopaminergic hypothesis and to develop “me too” drugs, imposing ill-defined research domain criteria, and lacking federal funding for clinical trials. The classification of APMs is also confusing, including second-generation, partial agonists, and multimodal APMs in the same class of APMs, despite significant differences in their mechanisms of action. Other factors stagnating drug development include inadequate sample sizes to address heterogeneity, lack of statistical measures correlating with clinical significance, using the atheoretical basis of psychiatric diagnoses, failure to control placebo response, and high cost of newer and perhaps more tolerable APMs. Furthermore, there has been a failure to develop early predictors of antipsychotic response and various tools to optimize an APM response. Finally, some mental health providers are also responsible for the suboptimal use of APMs, by using excessive maintenance doses, often with irrational polypharmacy, further compromising effectiveness and medication adherence. However, some bright spots in antipsychotic development include improved tolerability of APMs and long-acting injectables to address the high prevalence of medication nonadherence. This review critically reviews 70 years of antipsychotic development, the reasons behind the failure to develop more effective APMs, and suggestions for future direction. Full article

(This article belongs to the Special Issue Antipsychotics: 70 Years)

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13 pages, 1465 KiB

Open AccessReview

Antipsychotic Drugs Efficacy in Dextromethorphan-Induced Psychosis

by Malgorzata Zaremba, Pawel Serafin and Patrycja Kleczkowska

Biomedicines 2023, 11(1), 123; https://doi.org/10.3390/biomedicines11010123 - 03 Jan 2023

Cited by 1 | Viewed by 5013

Abstract

Psychosis is known as a broad term of symptoms that cause serious disorganization of behavior, thinking, and perception of reality. One of the medicines that recently gained much attention in terms of its psychotic potential is dextromethorphan (DXM). DXM, a widely used antitussive [...] Read more.

Psychosis is known as a broad term of symptoms that cause serious disorganization of behavior, thinking, and perception of reality. One of the medicines that recently gained much attention in terms of its psychotic potential is dextromethorphan (DXM). DXM, a widely used antitussive drug, is a commonly abused drug because of its euphoric, hallucinogenic, and dissociative properties. To date, DXM is a legally marketed cough suppressant that is neither a controlled substance nor a regulated chemical under the Controlled Substances Act. The management of DXM-related psychosis is dependent on the type of psychotic symptoms. Atypical neuroleptics (i.e., olanzapine, risperidone, quetiapine) and typical haloperidol have been used in symptomatic treatment due to their efficacy, especially in positive symptoms (hallucinations and delusions). These agents are also recognized as the preferred option in the symptomatic treatment of DXM-related psychosis due to their better efficacy and safety profile than typical haloperidol in the short-term course. The focus of the present review concerns the current stage of knowledge about DXM psychotic potency as well as the management of DXM-related psychoses with a special emphasis on atypical antipsychotic drugs (i.e., olanzapine, risperidone, quetiapine, and haloperidol). Full article

(This article belongs to the Special Issue Antipsychotics: 70 Years)

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16 pages, 1013 KiB

Open AccessReview

Seventy Years of Treating Delusional Disorder with Antipsychotics: A Historical Perspective

by Alexandre González-Rodríguez, José A. Monreal, Mentxu Natividad and Mary V. Seeman

Biomedicines 2022, 10(12), 3281; https://doi.org/10.3390/biomedicines10123281 - 18 Dec 2022

Cited by 7 | Viewed by 6413

Abstract

For many decades, delusional disorder (DD) has been considered a treatment-resistant disorder, with antipsychotics acknowledged as the best, though imperfect, treatment. It is possible that the discovery of the right drug could turn treatment resistance into treatment response. The goal of this narrative [...] Read more.

For many decades, delusional disorder (DD) has been considered a treatment-resistant disorder, with antipsychotics acknowledged as the best, though imperfect, treatment. It is possible that the discovery of the right drug could turn treatment resistance into treatment response. The goal of this narrative review is to provide a historical perspective of the treatment of DD since the introduction of antipsychotics 70 years ago. The following search terms were used to scan the literature: antipsychotics AND “delusional disorder”. Findings were that therapy for DD symptoms has changed over time. Initial reports suggested that the drug of choice was the antipsychotic pimozide, and that this drug was especially effective for the somatic subtype of DD. Subsequent studies demonstrated that other antipsychotics, for instance, risperidone and olanzapine, were also highly effective. Treatment response may vary according to the presence or absence of specific symptoms, such as cognitive defect and depression. Clozapine, partial D2 agonists, and long-acting injectable drugs may be more effective than other drugs, but the evidence is not yet in. Because of the absence of robust evidence, treatment guidelines for the optimal management of DD are not yet available. Full article

(This article belongs to the Special Issue Antipsychotics: 70 Years)

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18 pages, 335 KiB

Open AccessReview

Pharmacogenetics and Schizophrenia—Can Genomics Improve the Treatment with Second-Generation Antipsychotics?

by Olga Płaza, Piotr Gałecki, Agata Orzechowska, Małgorzata Gałecka, Justyna Sobolewska-Nowak and Agata Szulc

Biomedicines 2022, 10(12), 3165; https://doi.org/10.3390/biomedicines10123165 - 07 Dec 2022

Cited by 7 | Viewed by 1940

Abstract

Schizophrenia (SCZ) is a complex psychiatric disorder of multifactorial origin, in which both genetic and environmental factors have an impact on its onset, course, and outcome. Large variability in response and tolerability of medication among individuals makes it difficult to predict the efficacy [...] Read more.

Schizophrenia (SCZ) is a complex psychiatric disorder of multifactorial origin, in which both genetic and environmental factors have an impact on its onset, course, and outcome. Large variability in response and tolerability of medication among individuals makes it difficult to predict the efficacy of a chosen therapeutic method and create universal and precise guidelines for treatment. Pharmacogenetic research allows for the identification of genetic polymorphisms associated with response to a chosen antipsychotic, thus allowing for a more effective and personal approach to treatment. This review focuses on three frequently prescribed second-generation antipsychotics (SGAs), risperidone, olanzapine, and aripiprazole, and aims to analyze the current state and future perspectives in research dedicated to identifying genetic factors associated with antipsychotic response. Multiple alleles of genes involved in pharmacokinetics (particularly isoenzymes of cytochrome P450), as well as variants of genes involved in dopamine, serotonin, and glutamate neurotransmission, have already been identified as ones of significant impact on antipsychotic response. It must, however, be noted that although currently obtained results are promising, trials with bigger study groups and unified protocols are crucial for standardizing methods and determining objective antipsychotic response status. Full article

(This article belongs to the Special Issue Antipsychotics: 70 Years)

19 pages, 864 KiB

Open AccessReview

Antipsychotics in the Management of Disruptive Behavior Disorders in Children and Adolescents: An Update and Critical Review

by Ravi Philip Rajkumar

Biomedicines 2022, 10(11), 2818; https://doi.org/10.3390/biomedicines10112818 - 04 Nov 2022

Cited by 5 | Viewed by 3059

Abstract

Disruptive behaviour disorders (DBDs) in childhood include conduct disorder (CD) and oppositional defiant disorder (ODD). Though psychological therapies are considered to be the first-line treatment for DBDs, many patients require adjunctive pharmacotherapy for the control of specific symptoms, such as aggression. Three prior [...] Read more.

Disruptive behaviour disorders (DBDs) in childhood include conduct disorder (CD) and oppositional defiant disorder (ODD). Though psychological therapies are considered to be the first-line treatment for DBDs, many patients require adjunctive pharmacotherapy for the control of specific symptoms, such as aggression. Three prior systematic reviews have examined the evidence for the use of antipsychotics in DBDs and have concluded that their efficacy is marginal and limited by adverse effects. This paper has two objectives: (i) to summarize the findings of existing systematic reviews of antipsychotics for the management of DBDs in children and adolescents (2012–2017), and (ii) to provide an update to these reviews by examining recent clinical trials of antipsychotics in this population, published in the period from 2 January 2017 to 10 October 2022. The PubMed, Scopus and ScienceDirect databases were searched for relevant citations using the search terms “disruptive behaviour disorder”, “oppositional defiant disorder”, “conduct disorder” and their variants, along with “antipsychotic”, “atypical antipsychotic” and the generic names of all currently approved atypical antipsychotics. Six relevant trials were identified during this period, including five randomized controlled trials and one naturalistic open-label trial. These trials were critically evaluated in terms of outcome measures, efficacy and safety. Overall, the data from these trials suggests that of all available antipsychotics, risperidone appears to be effective in the short-term management of DBDs. All available antipsychotics are associated with significant metabolic adverse effects in this population. These results are discussed in the light of global trends towards increasing off-label prescription of antipsychotic medication in children and adolescents and of recent literature on the neuropharmacology of aggression in this patient population. The need for rational, short-term use of these drugs is highlighted, as well as the importance of post-marketing surveillance for long-term or severe adverse events. Full article

(This article belongs to the Special Issue Antipsychotics: 70 Years)

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16 pages, 1596 KiB

Open AccessSystematic Review

Onset of Action of Selected Second-Generation Antipsychotics (Pines)–A Systematic Review and Meta-Analyses

by Rikke Meyer, Kenneth Skov, Inderjeet Kaur Dhillon, Emilie Olsson, Niels Albert Graudal, Lone Baandrup and Gesche Jürgens

Biomedicines 2023, 11(1), 82; https://doi.org/10.3390/biomedicines11010082 - 29 Dec 2022

Cited by 2 | Viewed by 2441

Abstract

Recommendations for duration of treatment with antipsychotics before considering a switch vary from 2 to 8 weeks, although several studies suggest a rapid onset of action. The objective of this review was to estimate time to onset of action and time to maximum [...] Read more.

Recommendations for duration of treatment with antipsychotics before considering a switch vary from 2 to 8 weeks, although several studies suggest a rapid onset of action. The objective of this review was to estimate time to onset of action and time to maximum antipsychotic effect of asenapine, olanzapine, quetiapine, and zotepine (pines). We searched bibliographic databases for randomized, placebo-controlled trials in adults with schizophrenia estimating the antipsychotic effect of pines over time. Thirty-five studies including 6331 patients diagnosed with chronic schizophrenia were included. We estimated the standardized mean differences (SMD) of changes in symptom score from baseline to follow-up between intervention and placebo groups across studies using meta-analysis techniques. The summarized effect across all included pines administered as immediate-release formulations showed a statistically significant effect at week 1 (SMD, −0.20 [CI95% −0.28, −0.13]), which increased until week 3 (SMD, −0.42 [CI95% −0.50, −0.34]), after which the effect leveled off (week 6: SMD, −0.53 [CI95% −0.62, −0.44]). The sensitivity analyses of the individual pines confirm this finding, although data sparsity increases variability and limits conclusiveness of these analyses. Full article

(This article belongs to the Special Issue Antipsychotics: 70 Years)

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29 pages, 1645 KiB

Open AccessSystematic Review

Antipsychotics-Induced Changes in Synaptic Architecture and Functional Connectivity: Translational Implications for Treatment Response and Resistance

by Andrea de Bartolomeis, Giuseppe De Simone, Mariateresa Ciccarelli, Alessia Castiello, Benedetta Mazza, Licia Vellucci and Annarita Barone

Biomedicines 2022, 10(12), 3183; https://doi.org/10.3390/biomedicines10123183 - 08 Dec 2022

Cited by 8 | Viewed by 2114

Abstract

Schizophrenia is a severe mental illness characterized by alterations in processes that regulate both synaptic plasticity and functional connectivity between brain regions. Antipsychotics are the cornerstone of schizophrenia pharmacological treatment and, beyond occupying dopamine D2 receptors, can affect multiple molecular targets, pre- and [...] Read more.

Schizophrenia is a severe mental illness characterized by alterations in processes that regulate both synaptic plasticity and functional connectivity between brain regions. Antipsychotics are the cornerstone of schizophrenia pharmacological treatment and, beyond occupying dopamine D2 receptors, can affect multiple molecular targets, pre- and postsynaptic sites, as well as intracellular effectors. Multiple lines of evidence point to the involvement of antipsychotics in sculpting synaptic architecture and remodeling the neuronal functional unit. Furthermore, there is an increasing awareness that antipsychotics with different receptor profiles could yield different interregional patterns of co-activation. In the present systematic review, we explored the fundamental changes that occur under antipsychotics’ administration, the molecular underpinning, and the consequences in both acute and chronic paradigms. In addition, we investigated the relationship between synaptic plasticity and functional connectivity and systematized evidence on different topographical patterns of activation induced by typical and atypical antipsychotics. Full article

(This article belongs to the Special Issue Antipsychotics: 70 Years)

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20 pages, 929 KiB

Open AccessSystematic Review

Antipsychotics in the Treatment of Children and Adolescents with Anorexia Nervosa: A Systematic Review

by Jacopo Pruccoli, Luca Bergonzini, Angela La Tempa and Antonia Parmeggiani

Biomedicines 2022, 10(12), 3167; https://doi.org/10.3390/biomedicines10123167 - 07 Dec 2022

Cited by 5 | Viewed by 2889

Abstract

Evidence about the use of pharmacologic agents in the treatment of Anorexia Nervosa (AN) is lacking, especially in childhood and adolescence. A systematic scoping review was conducted to outline current literature evidence about the use of antipsychotics in this population. A total of [...] Read more.

Evidence about the use of pharmacologic agents in the treatment of Anorexia Nervosa (AN) is lacking, especially in childhood and adolescence. A systematic scoping review was conducted to outline current literature evidence about the use of antipsychotics in this population. A total of 499 studies were identified with the initial search, and 28 of these studies were selected regarding the use of olanzapine (n = 13), risperidone (n = 4), aripiprazole (n = 3), chlorpromazine (n = 3), pimozide (n = 1) clotiapine (n = 1) and multiple antipsychotics (n = 3) in these patients. Overall, major side effects were reported infrequently; improvements in psychopathology and weight measures have been suggested in the majority of the considered studies. Nonetheless, the lack of RCT or good-quality studies strongly limits the generalizability of results in clinical practice. Full article

(This article belongs to the Special Issue Antipsychotics: 70 Years)

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