{"title":"Clozapine Use in Down Syndrome: A Surprising Paucity of Evidence.","authors":"Mark Ainsley Colijn","doi":"10.1097/JCP.0000000000001953","DOIUrl":"10.1097/JCP.0000000000001953","url":null,"abstract":"","PeriodicalId":15455,"journal":{"name":"Journal of Clinical Psychopharmacology","volume":" ","pages":"170-171"},"PeriodicalIF":2.9,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142978508","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}
{"title":"Analysis of Duloxetine-Related Adverse Events Using the Food and Drug Administration Adverse Event Reporting System: Implications for Monitoring and Management.","authors":"Meng Zhu, Shengxia Lv, Feiye Zhu, Yongsheng Zhang","doi":"10.1097/JCP.0000000000001966","DOIUrl":"10.1097/JCP.0000000000001966","url":null,"abstract":"<p><strong>Background: </strong>The objective of this study was to examine the characteristics of adverse drug reactions of duloxetine and investigate the potential precautions that may exist beyond the drug label.</p><p><strong>Methods: </strong>This study used data from the Food and Drug Administration Adverse Event Reporting System database 2004-2023 and the linked information of duloxetine. Four algorithms used to evaluate the correlation between duloxetine and adverse events include reporting odds ratio, proportional reporting ratio, Bayesian confidence propagation neural network, and multi-item gamma Poisson shrinker.</p><p><strong>Results: </strong>Adverse reactions involving duloxetine were associated with 24 System Organ Classes. Among them, the three most frequent systems affected were psychiatric disorders (reporting odds ratio [ROR] 5.05), nervous system disorders (ROR 2.27), and general medical conditions and administration site conditions (ROR 0.83). Of particular note, the number of reported cases and the risk of occurrence of adverse events of drug withdrawal syndrome (n = 7498), nausea (n = 7942), and headache (n = 5732) were the highest, increasing each year and reached a peak submission in 2017. More importantly, the occurrence of reproductive system and breast disorders (chisq 317.85) was not mentioned in the drug leaflet.</p><p><strong>Conclusions: </strong>Psychiatric and nervous system disorders are the most frequently reported adverse events associated with duloxetine, with drug withdrawal syndrome, nausea, and headache being especially common. The emergence of mood-related symptoms, such as agitation and irritability, underscores the need for vigilant monitoring of mental health. Additionally, potential risks affecting the reproductive system suggest areas for further attention. These findings highlight the importance of proactive monitoring to improve patient safety during duloxetine treatment.</p>","PeriodicalId":15455,"journal":{"name":"Journal of Clinical Psychopharmacology","volume":" ","pages":"96-105"},"PeriodicalIF":2.9,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143408111","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}
{"title":"Question: Is Pimozide Associated With Male Infertility?","authors":"Richard I Shader","doi":"10.1097/JCP.0000000000001972","DOIUrl":"10.1097/JCP.0000000000001972","url":null,"abstract":"","PeriodicalId":15455,"journal":{"name":"Journal of Clinical Psychopharmacology","volume":" ","pages":"174"},"PeriodicalIF":2.9,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143364624","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}
{"title":"Premature Ejaculation After Discontinuation of Venlafaxine in a Case of Bipolar Depression.","authors":"Nidhisha Bajaj, Yash Bajaj","doi":"10.1097/JCP.0000000000001970","DOIUrl":"10.1097/JCP.0000000000001970","url":null,"abstract":"","PeriodicalId":15455,"journal":{"name":"Journal of Clinical Psychopharmacology","volume":" ","pages":"162-163"},"PeriodicalIF":2.9,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143370825","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}
Nadir Yalçın, İzgi Bayraktar, Asli Akyol, Ilter Deger, Mehmet Fatih İman, Emre Mutlu, Sertaç Ak, Füsun Özmen, Melih Ö Babaoglu
{"title":"Pharmacogenetic Variant Related Higher-Than-Expected Clozapine Concentrations and Clozapine/Norclozapine Ratios in a Patient With Treatment-Resistant Schizoaffective Disorder: A Case Report.","authors":"Nadir Yalçın, İzgi Bayraktar, Asli Akyol, Ilter Deger, Mehmet Fatih İman, Emre Mutlu, Sertaç Ak, Füsun Özmen, Melih Ö Babaoglu","doi":"10.1097/JCP.0000000000001973","DOIUrl":"10.1097/JCP.0000000000001973","url":null,"abstract":"","PeriodicalId":15455,"journal":{"name":"Journal of Clinical Psychopharmacology","volume":" ","pages":"163-165"},"PeriodicalIF":2.9,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143399304","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}
{"title":"Comparison of Effectiveness and Tolerability of Clonidine and Trihexyphenidyl in Clozapine-Induced Hypersalivation.","authors":"Puangpet Pansawat, Wattanapong Pansawat, Sipanut Silaket, Teeraporn Sadira Supapaan, Tuanthon Boonlue","doi":"10.1097/JCP.0000000000001968","DOIUrl":"10.1097/JCP.0000000000001968","url":null,"abstract":"<p><strong>Purpose/background: </strong>Clozapine-induced hypersalivation is one of the most common bothersome adverse reactions of clozapine. The management strategies for this condition remain inadequately studied and understood. The objective of the study is to compare the effectiveness and tolerability of (1) trihexyphenidyl 5 mg/d, (2) clonidine 0.15 mg/d, or (3) a reduction of clozapine dosage by 25 to 50 mg/d for managing clozapine-induced hypersalivation.</p><p><strong>Methods/procedures: </strong>A randomized, open-label, non-placebo-controlled clinical trial was conducted from December 2023 to May 2024. Eligible patients were randomly assigned to 1 of 3 groups. Primary outcomes were assessed using the Drooling Severity and Frequency Scale (DSFS) and the Nocturnal Hypersalivation Rating Scale (NHRS) at baseline, week 4, and week 8. Quality of life assessed using the pharmaceutical therapy for quality of life short version and adverse drug reactions were recorded as secondary outcomes.</p><p><strong>Findings/results: </strong>A total of 67 patients were randomly assigned to 1 of 3 treatment groups. By week 8, significant reductions in DSFS and NHRS scores were observed in all groups, with clonidine showing the greatest improvement. Trihexyphenidyl was also effective, whereas reducing clozapine dose resulted in more modest improvements. Quality of life improved significantly across all groups, with the greatest improvement observed in the clonidine group. The most common adverse effects were dry mouth, constipation, drowsiness, and dizziness.</p><p><strong>Implications/conclusions: </strong>Clonidine and trihexyphenidyl appear to be more effective options for managing clozapine-induced hypersalivation compared to clozapine dose reduction.</p>","PeriodicalId":15455,"journal":{"name":"Journal of Clinical Psychopharmacology","volume":" ","pages":"76-84"},"PeriodicalIF":2.9,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143364621","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}
Christine M Pulido, Ifeanyi S Walson, Amy Yang, Catherine S Stika, Dorothy K Sit, Katherine L Wisner
{"title":"Differentiating Depressive Symptoms From Side Effects in Individuals With Major Depressive Disorder With Postpartum Onset.","authors":"Christine M Pulido, Ifeanyi S Walson, Amy Yang, Catherine S Stika, Dorothy K Sit, Katherine L Wisner","doi":"10.1097/JCP.0000000000001928","DOIUrl":"10.1097/JCP.0000000000001928","url":null,"abstract":"<p><strong>Purpose: </strong>Somatic symptoms are commonly seen in major depressive disorder (MDD) with postpartum onset and can be similar to side effects of antidepressant medications. The aim of this study is to determine whether the decline in depressive symptoms measured by the Structured Interview Guide for the Hamilton Depression Rating Scale with Atypical Depression Supplement (SIGH-ADS) is significantly associated with the decrease in somatic symptoms identified by the Asberg scale.</p><p><strong>Methods: </strong>A secondary analysis of data from a randomized controlled trial was conducted. The original 8-week trial included 62 participants and assessed the efficacy of sertraline versus estradiol transdermal patches and their respective placebos for MDD with postpartum onset. The SIGH-ADS scale was used to assess depression severity and the Asberg scale was used to evaluate treatment emergent side effects, defined as an increase of ≥2 from baseline measures. Correlation analyses were performed between total scale scores. The scales were compared to establish symptoms, which overlapped across scales versus symptoms, which were unique to each scale.</p><p><strong>Results: </strong>Positive correlations were observed between the SIGH-ADS and Asberg scales and across the 8-week trial in all 3 treatment groups (correlation coefficient range 0.468-0.712). Headache was the most frequent treatment emergent side effect (10 occurrences). Fourteen symptoms were found to overlap between the 2 scales.</p><p><strong>Conclusions: </strong>These findings underscore the importance of reviewing somatic symptoms before administering medication to discern true treatment emergent side effects, especially in populations recovering from labor and delivery. Somatic symptoms decline in parallel with depressive symptom scores during treatment, suggesting they are indicative of underlying illness rather than side effects.</p>","PeriodicalId":15455,"journal":{"name":"Journal of Clinical Psychopharmacology","volume":" ","pages":"106-110"},"PeriodicalIF":2.9,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142769469","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}
Salah-Eddine El Jabiry, Fatima Benkarroum, Mohammed Barrimi, Fatima Elghazouani, Bouchra Oneib
{"title":"Risperidone-Associated Stuttering in Patient With Schizophrenia: A Case Report.","authors":"Salah-Eddine El Jabiry, Fatima Benkarroum, Mohammed Barrimi, Fatima Elghazouani, Bouchra Oneib","doi":"10.1097/JCP.0000000000001950","DOIUrl":"10.1097/JCP.0000000000001950","url":null,"abstract":"","PeriodicalId":15455,"journal":{"name":"Journal of Clinical Psychopharmacology","volume":" ","pages":"157-160"},"PeriodicalIF":2.9,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142921837","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}
Robert James Flanagan, Stephen John Obee, Alice Hyun Min Kim, Susanna Every-Palmer
{"title":"Clozapine Dosage in Treatment-Refractory Schizophrenia: A Reply to Dr Grover and Colleagues.","authors":"Robert James Flanagan, Stephen John Obee, Alice Hyun Min Kim, Susanna Every-Palmer","doi":"10.1097/JCP.0000000000001955","DOIUrl":"10.1097/JCP.0000000000001955","url":null,"abstract":"","PeriodicalId":15455,"journal":{"name":"Journal of Clinical Psychopharmacology","volume":" ","pages":"172-173"},"PeriodicalIF":2.9,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142978507","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}
Suresh Durgam, Susan G Kozauer, Willie R Earley, Changzheng Chen, Jason Huo, Hassan Lakkis, Stephen Stahl, Roger S McIntyre
{"title":"Lumateperone for the Treatment of Major Depressive Disorder With Mixed Features or Bipolar Depression With Mixed Features: A Randomized Placebo-Controlled Trial.","authors":"Suresh Durgam, Susan G Kozauer, Willie R Earley, Changzheng Chen, Jason Huo, Hassan Lakkis, Stephen Stahl, Roger S McIntyre","doi":"10.1097/JCP.0000000000001964","DOIUrl":"10.1097/JCP.0000000000001964","url":null,"abstract":"<p><strong>Background: </strong>This randomized, double-blind, placebo-controlled trial (ClinicalTrials.gov identifer NCT04285515) evaluated efficacy and safety of lumateperone to treat major depressive episodes (MDEs) associated with major depressive disorder (MDD) or bipolar depression with mixed features.</p><p><strong>Procedures: </strong>Patients (18-75 years) with Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5)-defined MDD with mixed features (n = 185) or bipolar disorder with mixed features (n = 200) and experiencing an MDE were randomized 1:1 to 6-week placebo (n = 195) or lumateperone 42 mg (n = 193). Primary and key secondary endpoints were change from baseline to day 43 in Montgomery-Åsberg Depression Rating Scale Total and Clinical Global Impression Scale-Severity (CGI-S) scores in 3 populations with combined MDD/bipolar depression, individual MDD, and individual bipolar depression. Safety included adverse events (AEs), extrapyramidal symptoms, and laboratory parameters.</p><p><strong>Results: </strong>Lumateperone met the primary endpoint, significantly improving Montgomery-Åsberg Depression Rating Scale total score at day 43 in populations with combined MDD/bipolar depression (least squares mean difference vs placebo [LSMD], -5.7; 95% confidence interval [CI], -7.60,-3.84; effect size [ES], -0.64; P < 0.0001), MDD (LSMD, -5.9; 95% CI, -8.61,-3.29; ES, -0.67; P < 0.0001), and bipolar depression (LSMD, -5.7; 95% CI, -8.29,-3.05; ES, -0.64; P < 0.0001). Lumateperone significantly improved CGI-S and Young Mania Rating Scale total scores at day 43 in these populations. Lumateperone was well-tolerated. Treatment-emergent AEs (≥5%, twice placebo) in the combined population were somnolence (placebo, 1.6%; lumateperone, 12.5%), dizziness (placebo, 2.1%; lumateperone, 12.0%), and nausea (placebo, 1.6%; lumateperone, 9.9%). There were no mania/hypomania treatment-emergent AEs with lumateperone and minimal extrapyramidal symptoms or metabolic risk.</p><p><strong>Conclusions: </strong>Lumateperone 42 mg significantly improved depression symptoms and disease severity and was generally safe and well-tolerated in patients with MDD or bipolar depression with mixed features.</p>","PeriodicalId":15455,"journal":{"name":"Journal of Clinical Psychopharmacology","volume":" ","pages":"67-75"},"PeriodicalIF":2.9,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11882193/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143408128","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}