Pub Date : 2025-03-01Epub Date: 2024-02-29DOI: 10.1097/YIC.0000000000000541
Francesca Legnani, Lorenzo Tassi, Teresa Surace, Enrico Capuzzi, Alice Caldiroli, Massimo Clerici, Massimiliano Buoli
Depressive disorders are disabling conditions that account for high social costs. Pilates demonstrated to have several beneficial effects on health. Objective of this manuscript was to systematically review the literature about the effects of Pilates on depressive disorders. A bibliographic search was conducted in the main database sources (Pubmed, Medline, and Scopus). The inclusion criteria consisted of articles written in English language about the effectiveness of Pilates on depressive symptoms. Most of included studies are randomized controlled trials (10 out of 12). The available literature agrees in indicating that Pilates is effective in improving depressive symptoms especially when compared to inactivity and when this practice is administered for a medium-long period (8-16 weeks). In addition, Pilates seems to have at least comparable effectiveness than aerobic exercise. Pilates can be considered a reliable complementary treatment for people with depressive disorders. These findings should be interpreted considering the different types of practice administered as well as the different duration of the programs or rating scales used to assess mood symptoms. Studies with a more homogenous design are needed to confirm and make generalizable the results presented in this review.
{"title":"Is Pilates effective in improving depressive disorders? A comprehensive overview.","authors":"Francesca Legnani, Lorenzo Tassi, Teresa Surace, Enrico Capuzzi, Alice Caldiroli, Massimo Clerici, Massimiliano Buoli","doi":"10.1097/YIC.0000000000000541","DOIUrl":"10.1097/YIC.0000000000000541","url":null,"abstract":"<p><p>Depressive disorders are disabling conditions that account for high social costs. Pilates demonstrated to have several beneficial effects on health. Objective of this manuscript was to systematically review the literature about the effects of Pilates on depressive disorders. A bibliographic search was conducted in the main database sources (Pubmed, Medline, and Scopus). The inclusion criteria consisted of articles written in English language about the effectiveness of Pilates on depressive symptoms. Most of included studies are randomized controlled trials (10 out of 12). The available literature agrees in indicating that Pilates is effective in improving depressive symptoms especially when compared to inactivity and when this practice is administered for a medium-long period (8-16 weeks). In addition, Pilates seems to have at least comparable effectiveness than aerobic exercise. Pilates can be considered a reliable complementary treatment for people with depressive disorders. These findings should be interpreted considering the different types of practice administered as well as the different duration of the programs or rating scales used to assess mood symptoms. Studies with a more homogenous design are needed to confirm and make generalizable the results presented in this review.</p>","PeriodicalId":13698,"journal":{"name":"International Clinical Psychopharmacology","volume":" ","pages":"53-61"},"PeriodicalIF":2.1,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11781551/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139566260","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-03-01Epub Date: 2024-05-20DOI: 10.1097/YIC.0000000000000551
Sean D Hood, Olatunji Odufowora-Sita, Jean-Baptiste Briere, Marco Lucchino, Fatma Khrouf, Elzbieta Olewinska, Paulina Pierzchala, Marwa Mezghani, Mateusz Nikodem, Pierre Lévy
This systematic literature review aimed to assess the efficacy and tolerability of agomelatine versus approved medications for the treatment of generalized anxiety disorder (GAD) in adult patients. We selected randomized controlled trials on various medications used to treat GAD in adult patients. An existing systematic literature review ( Kong et al ., 2020 ) was used to identify relevant studies published before 2020. Outcomes of remission and discontinuation due to adverse events (AEs) were analyzed, following a random-effects network meta-analysis approach. Of 25 identified studies, 20 and 22 studies were included in the network meta-analysis for studying the remission and discontinuation (due to AEs) outcomes, respectively. A statistically significant difference in the remission rate was observed between agomelatine and pregabalin [odds ratio (OR), 2.22; 95% confidence interval (CI), 1.19-4.21]. For the other comparators, the results were nonsignificant; however, all the point estimates were in favor of agomelatine. Similarly, for discontinuation because of AEs, the point estimates leaned consistently toward agomelatine suggesting its higher tolerability. The probabilities of agomelatine having the highest remission rate and lowest discontinuation (due to AEs) rate were 67% and 68%, respectively. Based on its demonstrated effectiveness and tolerability, agomelatine can be considered as a drug of choice for the treatment of GAD.
{"title":"Systematic review and network meta-analysis of agomelatine for the treatment of generalized anxiety disorder in adult patients.","authors":"Sean D Hood, Olatunji Odufowora-Sita, Jean-Baptiste Briere, Marco Lucchino, Fatma Khrouf, Elzbieta Olewinska, Paulina Pierzchala, Marwa Mezghani, Mateusz Nikodem, Pierre Lévy","doi":"10.1097/YIC.0000000000000551","DOIUrl":"10.1097/YIC.0000000000000551","url":null,"abstract":"<p><p>This systematic literature review aimed to assess the efficacy and tolerability of agomelatine versus approved medications for the treatment of generalized anxiety disorder (GAD) in adult patients. We selected randomized controlled trials on various medications used to treat GAD in adult patients. An existing systematic literature review ( Kong et al ., 2020 ) was used to identify relevant studies published before 2020. Outcomes of remission and discontinuation due to adverse events (AEs) were analyzed, following a random-effects network meta-analysis approach. Of 25 identified studies, 20 and 22 studies were included in the network meta-analysis for studying the remission and discontinuation (due to AEs) outcomes, respectively. A statistically significant difference in the remission rate was observed between agomelatine and pregabalin [odds ratio (OR), 2.22; 95% confidence interval (CI), 1.19-4.21]. For the other comparators, the results were nonsignificant; however, all the point estimates were in favor of agomelatine. Similarly, for discontinuation because of AEs, the point estimates leaned consistently toward agomelatine suggesting its higher tolerability. The probabilities of agomelatine having the highest remission rate and lowest discontinuation (due to AEs) rate were 67% and 68%, respectively. Based on its demonstrated effectiveness and tolerability, agomelatine can be considered as a drug of choice for the treatment of GAD.</p>","PeriodicalId":13698,"journal":{"name":"International Clinical Psychopharmacology","volume":" ","pages":"62-74"},"PeriodicalIF":2.1,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11781552/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141158576","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-03-01Epub Date: 2025-01-29DOI: 10.1097/YIC.0000000000000561
Jeroen De Troij, Chris Bervoets
This study evaluates the impact of neuroscience-based nomenclature (NbN) training on psychiatric residents in Flanders, Belgium. Addressing Zemach et al.'s findings on NbN's potential, we investigated its application in clinical practice. We assessed changes in knowledge, prescribing habits, and communication skills through focus groups and a longitudinal survey. Our results indicated no statistically significant shifts post-training, highlighting the complexity of integrating NbN into clinical practice. These findings underscore the critical need for psychopharmacological nomenclature and psychopathology to evolve in tandem, ensuring that advancements in understanding mental disorders align with pharmacological education.
{"title":"Points regarding neuroscience-based nomenclature: evaluating its impact on psychiatric residency training.","authors":"Jeroen De Troij, Chris Bervoets","doi":"10.1097/YIC.0000000000000561","DOIUrl":"10.1097/YIC.0000000000000561","url":null,"abstract":"<p><p>This study evaluates the impact of neuroscience-based nomenclature (NbN) training on psychiatric residents in Flanders, Belgium. Addressing Zemach et al.'s findings on NbN's potential, we investigated its application in clinical practice. We assessed changes in knowledge, prescribing habits, and communication skills through focus groups and a longitudinal survey. Our results indicated no statistically significant shifts post-training, highlighting the complexity of integrating NbN into clinical practice. These findings underscore the critical need for psychopharmacological nomenclature and psychopathology to evolve in tandem, ensuring that advancements in understanding mental disorders align with pharmacological education.</p>","PeriodicalId":13698,"journal":{"name":"International Clinical Psychopharmacology","volume":"40 2","pages":"119-122"},"PeriodicalIF":2.1,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143065446","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-03-01Epub Date: 2024-05-10DOI: 10.1097/YIC.0000000000000552
Alice Caldiroli, Letizia M Affaticati, Enrico Capuzzi, Davide La Tegola, Fabrizia Colmegna, Massimo Clerici, Antonios Dakanalis, Massimiliano Buoli
A strong interplay exists between sleep and dietary habits, and sleep disturbances have been repeatedly documented in individuals with eating disorders (EDs). The orexin system - implicated in sleep regulation, energy homeostasis, and food reward - may represent a mechanist link between sleep alterations and disordered eating behaviors. Daridorexant is a dual orexin receptor antagonist (DORA) recently approved for the treatment of insomnia, with demonstrated efficacy and tolerability. Owing to its action on orexin neurons, the compound represents an intriguing option for addressing both sleep-related and core symptoms of EDs. By inhibiting motor hyperactivity, daridorexant may reduce excessive physical exercise in individuals with anorexia nervosa (AN) restricting type. Additionally, the compound may exert anti-binge effects, suggesting broad applicability in binge ED, bulimia nervosa, and binge/purging AN. In this framework, daridorexant emerges as a promising therapeutic option, offering a multifaceted approach to improving circadian rhythms, energy balance, and overall quality of life in individuals with diverse ED subtypes.
睡眠与饮食习惯之间存在着强烈的相互作用,睡眠障碍已多次被记录在饮食失调(ED)患者的病例中。奥曲肽系统与睡眠调节、能量平衡和食物奖赏有关,它可能是睡眠改变与饮食失调行为之间的机理联系。Daridorexant 是一种双重奥曲肽受体拮抗剂(DORA),最近被批准用于治疗失眠症,其疗效和耐受性均已得到证实。由于其对奥曲肽神经元的作用,该化合物是解决睡眠相关症状和肥胖症核心症状的一个令人感兴趣的选择。通过抑制运动亢进,daridorexant 可减少神经性厌食症(AN)限制型患者的过度运动。此外,该化合物还可能具有抗暴饮暴食的作用,这表明它广泛适用于暴饮暴食性厌食症、神经性贪食症和暴饮暴食/暴食性厌食症。在这一框架下,daridorexant 成为一种很有前景的治疗选择,它提供了一种多方面的方法来改善昼夜节律、能量平衡和不同 ED 亚型患者的整体生活质量。
{"title":"The potential use of daridorexant in eating disorders: beyond the treatment of insomnia?","authors":"Alice Caldiroli, Letizia M Affaticati, Enrico Capuzzi, Davide La Tegola, Fabrizia Colmegna, Massimo Clerici, Antonios Dakanalis, Massimiliano Buoli","doi":"10.1097/YIC.0000000000000552","DOIUrl":"10.1097/YIC.0000000000000552","url":null,"abstract":"<p><p>A strong interplay exists between sleep and dietary habits, and sleep disturbances have been repeatedly documented in individuals with eating disorders (EDs). The orexin system - implicated in sleep regulation, energy homeostasis, and food reward - may represent a mechanist link between sleep alterations and disordered eating behaviors. Daridorexant is a dual orexin receptor antagonist (DORA) recently approved for the treatment of insomnia, with demonstrated efficacy and tolerability. Owing to its action on orexin neurons, the compound represents an intriguing option for addressing both sleep-related and core symptoms of EDs. By inhibiting motor hyperactivity, daridorexant may reduce excessive physical exercise in individuals with anorexia nervosa (AN) restricting type. Additionally, the compound may exert anti-binge effects, suggesting broad applicability in binge ED, bulimia nervosa, and binge/purging AN. In this framework, daridorexant emerges as a promising therapeutic option, offering a multifaceted approach to improving circadian rhythms, energy balance, and overall quality of life in individuals with diverse ED subtypes.</p>","PeriodicalId":13698,"journal":{"name":"International Clinical Psychopharmacology","volume":" ","pages":"115-118"},"PeriodicalIF":2.1,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140898039","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-01Epub Date: 2024-02-06DOI: 10.1097/YIC.0000000000000533
Gianluca Borgiani, Chiara Possidente, Chiara Fabbri, Vincenzo Oliva, Mirjam Bloemendaal, Alejandro Arias Vasquez, Ted G Dinan, Eduard Vieta, Marco Menchetti, Diana De Ronchi, Alessandro Serretti, Giuseppe Fanelli
This review synthesizes the evidence on associations between antidepressant use and gut microbiota composition and function, exploring the microbiota's possible role in modulating antidepressant treatment outcomes. Antidepressants exert an influence on measures of gut microbial diversity. The most consistently reported differences were in β-diversity between those exposed to antidepressants and those not exposed, with longitudinal studies supporting a potential causal association. Compositional alterations in antidepressant users include an increase in the Bacteroidetes phylum, Christensenellaceae family, and Bacteroides and Clostridium genera, while a decrease was found in the Firmicutes phylum, Ruminococcaceae family, and Ruminococcus genus. In addition, antidepressants attenuate gut microbial differences between depressed and healthy individuals, modulate microbial serotonin transport, and influence microbiota's metabolic functions. These include lyxose degradation, peptidoglycan maturation, membrane transport, and methylerythritol phosphate pathways, alongside gamma-aminobutyric acid metabolism. Importantly, baseline increased α-diversity and abundance of the Roseburia and Faecalibacterium genera, in the Firmicutes phylum, are associated with antidepressant response, emerging as promising biomarkers. This review highlights the potential for gut microbiota as a predictor of treatment response and emphasizes the need for further research to elucidate the mechanisms underlying antidepressant-microbiota interactions. More homogeneous studies and standardized techniques are required to confirm these initial findings.
{"title":"The bidirectional interaction between antidepressants and the gut microbiota: are there implications for treatment response?","authors":"Gianluca Borgiani, Chiara Possidente, Chiara Fabbri, Vincenzo Oliva, Mirjam Bloemendaal, Alejandro Arias Vasquez, Ted G Dinan, Eduard Vieta, Marco Menchetti, Diana De Ronchi, Alessandro Serretti, Giuseppe Fanelli","doi":"10.1097/YIC.0000000000000533","DOIUrl":"10.1097/YIC.0000000000000533","url":null,"abstract":"<p><p>This review synthesizes the evidence on associations between antidepressant use and gut microbiota composition and function, exploring the microbiota's possible role in modulating antidepressant treatment outcomes. Antidepressants exert an influence on measures of gut microbial diversity. The most consistently reported differences were in β-diversity between those exposed to antidepressants and those not exposed, with longitudinal studies supporting a potential causal association. Compositional alterations in antidepressant users include an increase in the Bacteroidetes phylum, Christensenellaceae family, and Bacteroides and Clostridium genera, while a decrease was found in the Firmicutes phylum, Ruminococcaceae family, and Ruminococcus genus. In addition, antidepressants attenuate gut microbial differences between depressed and healthy individuals, modulate microbial serotonin transport, and influence microbiota's metabolic functions. These include lyxose degradation, peptidoglycan maturation, membrane transport, and methylerythritol phosphate pathways, alongside gamma-aminobutyric acid metabolism. Importantly, baseline increased α-diversity and abundance of the Roseburia and Faecalibacterium genera, in the Firmicutes phylum, are associated with antidepressant response, emerging as promising biomarkers. This review highlights the potential for gut microbiota as a predictor of treatment response and emphasizes the need for further research to elucidate the mechanisms underlying antidepressant-microbiota interactions. More homogeneous studies and standardized techniques are required to confirm these initial findings.</p>","PeriodicalId":13698,"journal":{"name":"International Clinical Psychopharmacology","volume":"40 1","pages":"3-26"},"PeriodicalIF":2.1,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11594561/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142768517","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-01Epub Date: 2024-11-27DOI: 10.1097/YIC.0000000000000507
Paula Jhoana Escobedo-Aedo, Irene Pans, Enrique Baca-García, Jose de Leon, María-Luisa Barrigón, Santiago Ovejero
{"title":"Dropped-Head syndrome: a possible new variant of clozapine-induced inflammation during titration.","authors":"Paula Jhoana Escobedo-Aedo, Irene Pans, Enrique Baca-García, Jose de Leon, María-Luisa Barrigón, Santiago Ovejero","doi":"10.1097/YIC.0000000000000507","DOIUrl":"10.1097/YIC.0000000000000507","url":null,"abstract":"","PeriodicalId":13698,"journal":{"name":"International Clinical Psychopharmacology","volume":"40 1","pages":"41-45"},"PeriodicalIF":2.1,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142750833","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-01Epub Date: 2024-01-22DOI: 10.1097/YIC.0000000000000527
Louis Chevalier, Samuel Bulteau, Louis Cheval, Jalal Charron, Anne Sauvaget, Andrew Laurin
Intranasal esketamine is used in France for treatment-resistant depression. Dissociative symptoms are common side effects during treatment sessions. We report a case of delayed spontaneous dissociative symptoms following esketamine administration. A 20-year-old female with treatment-resistant depression received esketamine treatment. Dissociative symptoms occurred during sessions and persisted at a distance, often accompanied by anxiety. Delayed dissociative phenomena disappeared within the fourth week of treatment by esketamine. The literature mainly discusses dissociation during esketamine treatment sessions, with limited data on differed spontaneous episodes. Three hypotheses are discussed concerning the mechanism of occurrence of these dissociative phenomena, including esketamine's direct effect, central nervous system sensitization, and anxiety-induced dissociation. We present the first case of differed spontaneous dissociative effects after intranasal esketamine administration for treatment-resistant depression. Our main hypothesis suggests that esketamine may act as a 'pattern' for dissociative experiences, heightening the patient's ability to discern these phenomena during other instances of dissociation, such as acute anxiety attacks. Further research is needed to validate this hypothesis.
{"title":"Differed spontaneous dissociative symptoms following the use of esketamine intranasal spray in a patient suffering from treatment-resistant depression: a case report.","authors":"Louis Chevalier, Samuel Bulteau, Louis Cheval, Jalal Charron, Anne Sauvaget, Andrew Laurin","doi":"10.1097/YIC.0000000000000527","DOIUrl":"10.1097/YIC.0000000000000527","url":null,"abstract":"<p><p>Intranasal esketamine is used in France for treatment-resistant depression. Dissociative symptoms are common side effects during treatment sessions. We report a case of delayed spontaneous dissociative symptoms following esketamine administration. A 20-year-old female with treatment-resistant depression received esketamine treatment. Dissociative symptoms occurred during sessions and persisted at a distance, often accompanied by anxiety. Delayed dissociative phenomena disappeared within the fourth week of treatment by esketamine. The literature mainly discusses dissociation during esketamine treatment sessions, with limited data on differed spontaneous episodes. Three hypotheses are discussed concerning the mechanism of occurrence of these dissociative phenomena, including esketamine's direct effect, central nervous system sensitization, and anxiety-induced dissociation. We present the first case of differed spontaneous dissociative effects after intranasal esketamine administration for treatment-resistant depression. Our main hypothesis suggests that esketamine may act as a 'pattern' for dissociative experiences, heightening the patient's ability to discern these phenomena during other instances of dissociation, such as acute anxiety attacks. Further research is needed to validate this hypothesis.</p>","PeriodicalId":13698,"journal":{"name":"International Clinical Psychopharmacology","volume":" ","pages":"37-40"},"PeriodicalIF":2.1,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139566334","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-01Epub Date: 2024-11-27DOI: 10.1097/YIC.0000000000000528
Michael E Thase, Paul P Yeung, Ludmyla Rekeda, Meng Liu, Shane Varughese
To characterize the safety and tolerability of adjunctive cariprazine in patients with major depressive disorder (MDD) and inadequate response to monotherapy antidepressant treatment (ADT). Post hoc analyses evaluated pooled data from 2 fixed-dose phase 3 cariprazine studies (1.5 and 3 mg/d [approved doses for MDD]). In a separate safety analysis, cariprazine 0.1-4.5 mg/d was evaluated using data from the 2 fixed-dose trials plus 3 flexible-dose studies grouped by modal-daily dose. In the pooled phase 3 studies (placebo = 503, 1.5 mg/d = 502, 3 mg/d = 503), overall cariprazine-treated patients had high rates of study completion (90%). Patients had mostly mild/moderate treatment-emergent adverse events that caused premature discontinuation of 4.3%. Only akathisia, nausea, and insomnia occurred in ≥5% of cariprazine patients (any group) and at twice the rate of placebo; potential dose-dependent responses were observed for akathisia and insomnia. Cariprazine had a neutral metabolic profile, with mean weight increase of <1 kg. Modal-dose results were similar, and both analyses were consistent with the known safety profile of cariprazine across its approved indications. Adjunctive cariprazine therapy was safe and generally well tolerated in patients with MDD who had not obtained an adequate response to ADT monotherapy; no new safety signals were identified.
{"title":"Safety and tolerability of cariprazine for the adjunctive treatment of major depressive disorder: a pooled analysis of phase 2b/phase 3 clinical trials.","authors":"Michael E Thase, Paul P Yeung, Ludmyla Rekeda, Meng Liu, Shane Varughese","doi":"10.1097/YIC.0000000000000528","DOIUrl":"10.1097/YIC.0000000000000528","url":null,"abstract":"<p><p>To characterize the safety and tolerability of adjunctive cariprazine in patients with major depressive disorder (MDD) and inadequate response to monotherapy antidepressant treatment (ADT). Post hoc analyses evaluated pooled data from 2 fixed-dose phase 3 cariprazine studies (1.5 and 3 mg/d [approved doses for MDD]). In a separate safety analysis, cariprazine 0.1-4.5 mg/d was evaluated using data from the 2 fixed-dose trials plus 3 flexible-dose studies grouped by modal-daily dose. In the pooled phase 3 studies (placebo = 503, 1.5 mg/d = 502, 3 mg/d = 503), overall cariprazine-treated patients had high rates of study completion (90%). Patients had mostly mild/moderate treatment-emergent adverse events that caused premature discontinuation of 4.3%. Only akathisia, nausea, and insomnia occurred in ≥5% of cariprazine patients (any group) and at twice the rate of placebo; potential dose-dependent responses were observed for akathisia and insomnia. Cariprazine had a neutral metabolic profile, with mean weight increase of <1 kg. Modal-dose results were similar, and both analyses were consistent with the known safety profile of cariprazine across its approved indications. Adjunctive cariprazine therapy was safe and generally well tolerated in patients with MDD who had not obtained an adequate response to ADT monotherapy; no new safety signals were identified.</p>","PeriodicalId":13698,"journal":{"name":"International Clinical Psychopharmacology","volume":" ","pages":"27-36"},"PeriodicalIF":2.1,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11594553/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139563327","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}