{"title":"Examining Alternative Inclusion Criteria Based on Core Symptoms of Depression in Antidepressant Clinical Trials.","authors":"Evyn M Peters, Saba Aziz, Lloyd Balbuena","doi":"10.1097/JCP.0000000000001926","DOIUrl":"10.1097/JCP.0000000000001926","url":null,"abstract":"","PeriodicalId":15455,"journal":{"name":"Journal of Clinical Psychopharmacology","volume":"45 1","pages":"46-47"},"PeriodicalIF":2.9,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142877231","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}
Jessica L Heaton, Siobhan A Campbell, Hayley A Bradley, Roger T Mulder, Lesley Dixon, Jacki Henderson, Julia J Rucklidge
{"title":"Broad-Spectrum Micronutrients or Antidepressants for Antenatal Depression: Effect on Maternal and Infant Birth Outcomes in an Observational Secondary Analysis of NUTRIMUM.","authors":"Jessica L Heaton, Siobhan A Campbell, Hayley A Bradley, Roger T Mulder, Lesley Dixon, Jacki Henderson, Julia J Rucklidge","doi":"10.1097/JCP.0000000000001934","DOIUrl":"10.1097/JCP.0000000000001934","url":null,"abstract":"<p><strong>Purpose/background: </strong>One-fifth of women experience antenatal depression. Untreated antenatal depression is associated with increased risk of adverse birth outcomes. This study investigated the effect of broad-spectrum micronutrients (BSM; vitamins and minerals), used to treat antenatal depression (NUTRIMUM trial), on birth outcomes.</p><p><strong>Methods/procedures: </strong>Birth outcomes of 129 mother-infant pairs were obtained from hospital medical records or personal health records for home births. Pairs from NUTRIMUM exposed to ≥8 weeks of BSM antenatally (MN; n = 55) were compared to pairs exposed to antidepressants antenatally (MED; n = 20) and a reference group (REF; n = 54) of pairs not exposed to trial BSM or antidepressants.</p><p><strong>Findings/results: </strong>Groups were comparable on demographic variables. At study entry, MN and MED had depression scores in the moderate range, statistically higher than REF (nonclinical range). MN and REF did not differ significantly for gestational age, preterm births, infant size, or infant resuscitation. There were significantly lower rates of postpartum hemorrhage in MN relative to REF (7.7% vs 30%; RR = 0.26, 95% CI [0.08-0.84]). Gestational age at birth was higher for MN (39.5 weeks) than MED (38.5 weeks; d = 0.67, 95% CI [0.15-1.20], P = 0.03) as well as infant birth length (52.2 vs 50.0 cm; d = 0.77, 95% CI [0.21-1.33], P = 0.02), and rates of infant resuscitation were lower (14.5% vs 45%; RR = 0.33, 95% CI [0.15-0.73]). Days of BSM exposure was positively associated with birth weight ( r = 0.32, P = 0.008) and length ( r = 0.25, P = 0.04).</p><p><strong>Implications/conclusions: </strong>Micronutrients used to alleviate antenatal depression may mitigate negative effects of depression on birth outcomes and showed more favorable birth outcomes compared with antidepressants.</p>","PeriodicalId":15455,"journal":{"name":"Journal of Clinical Psychopharmacology","volume":" ","pages":"4-15"},"PeriodicalIF":2.9,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142769466","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":"Citalopram Associated with the Development of Tinnitus in an Adolescent Girl: A Case Report.","authors":"Hasibe Ağır, Fatma Coşkun","doi":"10.1097/JCP.0000000000001937","DOIUrl":"10.1097/JCP.0000000000001937","url":null,"abstract":"","PeriodicalId":15455,"journal":{"name":"Journal of Clinical Psychopharmacology","volume":"45 1","pages":"57-58"},"PeriodicalIF":2.9,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142877229","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}
Liliana Patarroyo-Rodriguez, Jennifer L Vande Voort, Simon Kung, Sarah K Brown, Stefanie Cavalcanti, Matthew J Ritter, Balwinder Singh
{"title":"Noncardiac Chest Pain and Hypertensive Urgency During Long-term Intravenous Racemic Ketamine for Treatment-Resistant Depression.","authors":"Liliana Patarroyo-Rodriguez, Jennifer L Vande Voort, Simon Kung, Sarah K Brown, Stefanie Cavalcanti, Matthew J Ritter, Balwinder Singh","doi":"10.1097/JCP.0000000000001939","DOIUrl":"10.1097/JCP.0000000000001939","url":null,"abstract":"","PeriodicalId":15455,"journal":{"name":"Journal of Clinical Psychopharmacology","volume":"45 1","pages":"49-52"},"PeriodicalIF":2.9,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11745506/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142877234","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}
{"title":"The Treatment of Iatrogenic Anorgasmia in a Male Patient on Clozapine for Treatment-Resistant Schizophrenia: The Role of Pseudoephedrine.","authors":"Paul O'Connell, Mohamed Alsaffar","doi":"10.1097/JCP.0000000000001930","DOIUrl":"10.1097/JCP.0000000000001930","url":null,"abstract":"","PeriodicalId":15455,"journal":{"name":"Journal of Clinical Psychopharmacology","volume":" ","pages":"55-57"},"PeriodicalIF":2.9,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142620493","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":"Recurrent Pancreatitis Associated With Atomoxetine Use in a 9-Year-Old Boy: A Case Report.","authors":"Ömer Faruk Bulut, Ali Karayağmurlu","doi":"10.1097/JCP.0000000000001938","DOIUrl":"10.1097/JCP.0000000000001938","url":null,"abstract":"","PeriodicalId":15455,"journal":{"name":"Journal of Clinical Psychopharmacology","volume":" ","pages":"48-49"},"PeriodicalIF":2.9,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142750456","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":"Ethics in Psychedelic Science: Promises and Responsibilities.","authors":"Dominic Sisti","doi":"10.1097/JCP.0000000000001944","DOIUrl":"10.1097/JCP.0000000000001944","url":null,"abstract":"","PeriodicalId":15455,"journal":{"name":"Journal of Clinical Psychopharmacology","volume":" ","pages":"1-3"},"PeriodicalIF":2.9,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142729107","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}
Michael T Sapko, Cortney Kolesar, Ian R Sharp, Jonathan C Javitt
{"title":"Quality Assurance of Depression Ratings in Psychiatric Clinical Trials.","authors":"Michael T Sapko, Cortney Kolesar, Ian R Sharp, Jonathan C Javitt","doi":"10.1097/JCP.0000000000001936","DOIUrl":"10.1097/JCP.0000000000001936","url":null,"abstract":"<p><strong>Background: </strong>Extensive experience with antidepressant clinical trials indicates that interrater reliability (IRR) must be maintained to achieve reliable clinical trial results. Contract research organizations have generally accepted 6 points of rating disparity between study site raters and central \"master raters\" as concordant, in part because of the personnel turnover and variability within many contract research organizations. We developed and tested an \"insourced\" model using a small, dedicated team of rater program managers (RPMs), to determine whether 3 points of disparity could successfully be demonstrated as a feasible standard for rating concordance.</p><p><strong>Methods: </strong>Site raters recorded and scored all Montgomery-Åsberg Depression Rating Scale (MADRS) interviews. Audio files were independently reviewed and scored by RPMs within 24 to 48 hours. Concordance was defined as the absolute difference in MADRS total score of 3 points or less. A MADRS total score that differed by 4 or more points triggered a discussion with the site rater and additional training, as needed.</p><p><strong>Results: </strong>In a sample of 236 ratings (58 patients), IRR between site ratings and blinded independent RPM ratings was 94.49% (223/236). The lowest concordance, 87.93%, occurred at visit 2, which was the baseline visit in the clinical trial. Concordance rates at visits 3, 4, 5, and 6 were 93.75%, 96.08%, 97.30%, and 100.00%, respectively. The absolute mean difference in MADRS rating pairs was 1.77 points (95% confidence interval: 1.58-1.95). The intraclass correlation was 0.984 and an η2 = 0.992 (F = 124.35, P < 0.0001).</p><p><strong>Conclusions: </strong>Rigorous rater training together with real-time monitoring of site raters by RPMs can achieve a high degree of IRR on the MADRS.</p>","PeriodicalId":15455,"journal":{"name":"Journal of Clinical Psychopharmacology","volume":"45 1","pages":"28-31"},"PeriodicalIF":2.9,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142877238","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}