International Clinical Psychopharmacology最新文献

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Brexpiprazole augmentation in treatment-resistant obsessive-compulsive disorder: a preliminary retrospective observational study. 布瑞吡拉唑增强治疗难治性强迫症:一项初步回顾性观察研究。
IF 2.1 3区 医学
International Clinical Psychopharmacology Pub Date : 2025-02-06 DOI: 10.1097/YIC.0000000000000583
Luca Giacovelli, Eleonora Piccoli, Paola Landi, Matteo Vismara, Beatrice Benatti, Bernardo Dell'Osso
{"title":"Brexpiprazole augmentation in treatment-resistant obsessive-compulsive disorder: a preliminary retrospective observational study.","authors":"Luca Giacovelli, Eleonora Piccoli, Paola Landi, Matteo Vismara, Beatrice Benatti, Bernardo Dell'Osso","doi":"10.1097/YIC.0000000000000583","DOIUrl":"10.1097/YIC.0000000000000583","url":null,"abstract":"<p><p>Obsessive-compulsive disorder (OCD) is a chronic illness associated with significant functional impairment. Monotherapy with serotonin reuptake inhibitors (SRIs) often leads to only partial improvement of symptoms. In such cases, a common, well established, treatment approach for most patients is the augmentation of SRI therapy with antipsychotic medications. Brexpiprazole is an atypical antipsychotic agent that acts as a partial agonist of 5-HT1A, D2, and D3 receptors. Purpose of this retrospective observational study was to evaluate the effectiveness and tolerability of brexpiprazole as augmentation to SRIs in patients with treatment-resistant OCD. This preliminary study included a sample of 10 patients diagnosed with treatment-resistant OCD who underwent a 12-week trial of augmentative brexpiprazole, starting at a dose of 1 mg/day, with dosage adjustments based on clinical judgment. Treatment response was assessed through changes in the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) total score from baseline to the end of the 12-week observation period. Adverse events were systematically recorded. Significant improvement was observed after the 12-week period: at the endpoint, seven patients (70%) achieved a ≥25% reduction in Y-BOCS total score compared to baseline, with five of them (50% of the overall sample) showing a more robust clinical response (≥35% reduction). Mild adverse effects, such as sedation and weight gain, were reported by two participants (20% of the overall sample). These findings suggest that brexpiprazole may offer a promising effectiveness and tolerability profile in the management of treatment-resistant OCD.</p>","PeriodicalId":13698,"journal":{"name":"International Clinical Psychopharmacology","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2025-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143255480","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}
引用次数: 0
Differentiating aspects of oral and long-acting injectable antipsychotic drugs for tailoring the therapy of schizophrenia in clinical practice: a narrative review. 在临床实践中区分口服和长效注射抗精神病药物对精神分裂症治疗的影响:一篇叙述性综述。
IF 2.1 3区 医学
International Clinical Psychopharmacology Pub Date : 2025-01-22 DOI: 10.1097/YIC.0000000000000578
Andrea Fagiolini, Alessandro Cuomo, Domenico De Berardis, Bernardo Dell'Osso, Maurizio Pompili, Gianluca Serafini
{"title":"Differentiating aspects of oral and long-acting injectable antipsychotic drugs for tailoring the therapy of schizophrenia in clinical practice: a narrative review.","authors":"Andrea Fagiolini, Alessandro Cuomo, Domenico De Berardis, Bernardo Dell'Osso, Maurizio Pompili, Gianluca Serafini","doi":"10.1097/YIC.0000000000000578","DOIUrl":"https://doi.org/10.1097/YIC.0000000000000578","url":null,"abstract":"<p><p>Schizophrenia is a serious psychiatric condition requiring continuous treatment with antipsychotic medications available in different formulations, including oral antipsychotics (OAPs) and long-acting injectables (LAIs). This narrative review aims to comprehensively outline the advantages and disadvantages of OAPs and LAIs to support clinicians in choosing different formulations based on the presentation of clinical symptoms. An electronic search of the PubMed database was performed in June 2024, and additional articles were retrieved from the references or personal knowledge of the authors. Relevant advantages of OAPs identified in the literature include dosing flexibility, ease of discontinuation, lower cost, autonomy of patient administration, shorter time to steady-state, and wide choice of molecules, including risk of nonadherence, plasma level fluctuations, food and drug interactions, and polypharmacy. LAIs' advantages include improved adherence leading to reduced relapse rates and hospitalizations, patient convenience, and stable drug levels while disadvantages include discomfort of injection, possible stigma, less manageable drug interactions, organization of administration centers, and patient preference possibly contrary to physician preference. When treating schizophrenia, it is critical to consider patients' needs, preferences, and history of medication adherence. Combining patient education with individualized treatment plans may optimize outcomes and improve the quality of life.</p>","PeriodicalId":13698,"journal":{"name":"International Clinical Psychopharmacology","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2025-01-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143004952","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}
引用次数: 0
Intravenous trazodone for the treatment of psychomotor agitation and associated symptoms in major depressive disorder patients experiencing a depressive episode with mixed features. 静脉曲唑酮治疗伴有混合特征的抑郁发作的重度抑郁症患者的精神运动性躁动及相关症状
IF 2.1 3区 医学
International Clinical Psychopharmacology Pub Date : 2025-01-13 DOI: 10.1097/YIC.0000000000000580
Pietro Carmellini, Alessandro Cuomo, Caterina Pierini, Simone Pardossi, Mario Pinzi, Elisa Mariantoni, Andrea Fagiolini
{"title":"Intravenous trazodone for the treatment of psychomotor agitation and associated symptoms in major depressive disorder patients experiencing a depressive episode with mixed features.","authors":"Pietro Carmellini, Alessandro Cuomo, Caterina Pierini, Simone Pardossi, Mario Pinzi, Elisa Mariantoni, Andrea Fagiolini","doi":"10.1097/YIC.0000000000000580","DOIUrl":"https://doi.org/10.1097/YIC.0000000000000580","url":null,"abstract":"<p><p>Psychomotor agitation is a challenging symptom of major depressive disorder with mixed features (MDD-MF), often worsening outcomes and complicating treatment. This retrospective study assessed the efficacy and tolerability of intravenous trazodone in 97 hospitalized patients with MDE-MF. Symptom severity was evaluated using montgomery asberg depression rating Scale (MADRS), young mania rating scale, hamilton anxiety rating scale, GAD-7, and clinical global impression scale-severity of illness (CGI-S) scales, with significant reductions in agitation, anxiety, and irritability observed early during treatment. Correlation analyses revealed significant negative associations between intravenous (IV) trazodone dosage and improvements in MADRS (r = -0.23; P < 0.05), item 5 of GAD-7 (r = -0.27; P < 0.001), and CGI-S scores (r = -0.22; P < 0.05). Therapy duration also correlated negatively with improvements in GAD-7 item 5 (r = -0.29; P < 0.001) and CGI-S (r = -0.27; P < 0.001), indicating diminishing returns with prolonged treatment. Regression analyses showed that therapy duration, but not dosage, significantly influenced improvements in GAD-7 item 5 and CGI-S. Trazodone was well-tolerated, with only mild side effects in 11.3% of patients. These findings suggest that IV trazodone effectively reduces agitation and related symptoms in MDD-MF, particularly in the early treatment phase, emphasizing the importance of optimizing treatment duration. Future studies should investigate individualized dosing strategies and explore long-term outcomes in this population.</p>","PeriodicalId":13698,"journal":{"name":"International Clinical Psychopharmacology","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2025-01-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143004954","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}
引用次数: 0
Managing depression in the elderly: real-world clinical considerations and perspectives. 老年人抑郁症的管理:现实世界的临床考虑和观点。
IF 2.1 3区 医学
International Clinical Psychopharmacology Pub Date : 2025-01-09 DOI: 10.1097/YIC.0000000000000577
Siegfried Kasper, Raffaele Antonelli Incalzi, Marco Bozzali, Pedro Morgado, Marcin Siwek
{"title":"Managing depression in the elderly: real-world clinical considerations and perspectives.","authors":"Siegfried Kasper, Raffaele Antonelli Incalzi, Marco Bozzali, Pedro Morgado, Marcin Siwek","doi":"10.1097/YIC.0000000000000577","DOIUrl":"https://doi.org/10.1097/YIC.0000000000000577","url":null,"abstract":"<p><p>This study aims to elucidate current trends in clinical practice for managing depression in elderly patients, focusing on the utilization of pharmacotherapeutics and integrated care models to improve patient outcomes. A comprehensive survey was conducted among physicians from various European countries to gather insights into prescribing habits, treatment patterns, and the impact of comorbidities on therapeutic choices, with a focus on trazodone. The participants included psychiatrists, general practitioners, and neurologists actively involved in elderly depression care. The findings reveal a preference among physicians for using antidepressants like trazodone, due to efficacy and tolerability. Selective serotonin reuptake inhibitors and serotonin-noradrenaline reuptake inhibitors were also commonly prescribed, while tricyclic antidepressants and monoamine oxidase inhibitors were less favored. Psychiatric conditions and sleep disturbances significantly influenced treatment decisions. The survey underscored the importance of multidisciplinary management and the crucial role of caregivers in the treatment process. Effective management of depression in the elderly demands a precision approach that incorporates a thorough understanding of pharmacology, comorbidities, and a collaborative approach to maximize the effects of treatment while trying to minimize polypharmacy and the co-occurring side effects. The study highlights the need for tailored treatment strategies that address the complex needs of the elderly to enhance their quality of life and treatment outcomes.</p>","PeriodicalId":13698,"journal":{"name":"International Clinical Psychopharmacology","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2025-01-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142970559","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}
引用次数: 0
Age matters when improving symptoms of anxiety, depression, and sleepiness in patients with obstructive sleep apnea treated with continuous positive airway pressure. 在持续气道正压治疗的阻塞性睡眠呼吸暂停患者中,年龄对焦虑、抑郁和嗜睡症状的改善有影响。
IF 2.1 3区 医学
International Clinical Psychopharmacology Pub Date : 2025-01-08 DOI: 10.1097/YIC.0000000000000579
Amitoj Singh, Sanket Meghpara, Rijesh Niraula, Lynn Keenan, Lourdes M DelRosso
{"title":"Age matters when improving symptoms of anxiety, depression, and sleepiness in patients with obstructive sleep apnea treated with continuous positive airway pressure.","authors":"Amitoj Singh, Sanket Meghpara, Rijesh Niraula, Lynn Keenan, Lourdes M DelRosso","doi":"10.1097/YIC.0000000000000579","DOIUrl":"https://doi.org/10.1097/YIC.0000000000000579","url":null,"abstract":"<p><p>Obstructive sleep apnea (OSA) is a prevalent sleep disorder linked to significant daytime sleepiness and mood disturbances. Continuous positive airway pressure (CPAP) therapy is the standard treatment for OSA, but its effects on mental health outcomes, are not well understood. This study aimed to evaluate the impact of CPAP on daytime sleepiness, depressive symptoms, and anxiety symptoms while assessing how improvements vary with age. A total of 98 participants diagnosed with OSA were included in this study. Pretreatment and posttreatment scores for daytime sleepiness [Epworth Sleepiness Scale (ESS)], depression [Patient Health Questionnaire (PHQ)], and anxiety [Generalized Anxiety Disorder (GAD)] were collected. Improvements were calculated as the difference between pretreatment and posttreatment scores. Age, sex, ethnicity, apnea-hypopnea index, and CPAP compliance, were analyzed. Significant improvements were observed across all age groups after CPAP treatment: ESS scores improved by a mean of 5.6 points (P < 0.001), PHQ scores improved by 6.3 points (P < 0.001), and GAD scores improved by 1.1 points (P = 0.002). CPAP therapy effectively reduced daytime sleepiness, depression, and anxiety in patients with OSA, with significant age-related differences in outcomes. Younger individuals benefited most from treatment.</p>","PeriodicalId":13698,"journal":{"name":"International Clinical Psychopharmacology","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2025-01-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142948370","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}
引用次数: 0
The bidirectional interaction between antidepressants and the gut microbiota: are there implications for treatment response? 抗抑郁药和肠道菌群之间的双向相互作用:对治疗反应有影响吗?
IF 2.1 3区 医学
International Clinical Psychopharmacology Pub Date : 2025-01-01 Epub Date: 2024-02-06 DOI: 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
{"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}
引用次数: 0
When antidepressants meet the gut microbiota: implications and challenges. 当抗抑郁药遇到肠道菌群:影响和挑战。
IF 2.1 3区 医学
International Clinical Psychopharmacology Pub Date : 2025-01-01 Epub Date: 2024-11-27 DOI: 10.1097/YIC.0000000000000558
Sofia Cussotto, Romain Colle, Denis J David, Emmanuelle Corruble
{"title":"When antidepressants meet the gut microbiota: implications and challenges.","authors":"Sofia Cussotto, Romain Colle, Denis J David, Emmanuelle Corruble","doi":"10.1097/YIC.0000000000000558","DOIUrl":"10.1097/YIC.0000000000000558","url":null,"abstract":"","PeriodicalId":13698,"journal":{"name":"International Clinical Psychopharmacology","volume":"40 1","pages":"46-48"},"PeriodicalIF":2.1,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142750842","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}
引用次数: 0
Dropped-Head syndrome: a possible new variant of clozapine-induced inflammation during titration. 低垂头综合征:氯氮平在滴定过程中引起炎症的一种可能的新变体。
IF 2.1 3区 医学
International Clinical Psychopharmacology Pub Date : 2025-01-01 Epub Date: 2024-11-27 DOI: 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}
引用次数: 0
Differed spontaneous dissociative symptoms following the use of esketamine intranasal spray in a patient suffering from treatment-resistant depression: a case report. 病例报告:一名耐药抑郁症患者使用埃司氯胺酮鼻内喷雾剂后出现的自发分离症状。
IF 2.1 3区 医学
International Clinical Psychopharmacology Pub Date : 2025-01-01 Epub Date: 2024-01-22 DOI: 10.1097/YIC.0000000000000527
Louis Chevalier, Samuel Bulteau, Louis Cheval, Jalal Charron, Anne Sauvaget, Andrew Laurin
{"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}
引用次数: 0
Safety and tolerability of cariprazine for the adjunctive treatment of major depressive disorder: a pooled analysis of phase 2b/phase 3 clinical trials. 卡利普嗪辅助治疗重度抑郁障碍的安全性和耐受性:2b期/3期临床试验的汇总分析。
IF 2.1 3区 医学
International Clinical Psychopharmacology Pub Date : 2025-01-01 Epub Date: 2024-11-27 DOI: 10.1097/YIC.0000000000000528
Michael E Thase, Paul P Yeung, Ludmyla Rekeda, Meng Liu, Shane Varughese
{"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}
引用次数: 0
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