Joyce H L Lui, Andrea Chronis-Tuscano, Daniel Almirall, Kathryn B Whitlock, William French, Mark A Stein
{"title":"Sequencing Stimulant Medication and Behavioral Parent Training in Multiplex ADHD Families: A Pilot SMART.","authors":"Joyce H L Lui, Andrea Chronis-Tuscano, Daniel Almirall, Kathryn B Whitlock, William French, Mark A Stein","doi":"10.4088/JCP.24m15463","DOIUrl":"10.4088/JCP.24m15463","url":null,"abstract":"<p><p><b>Objective:</b> To examine the effects of treatment sequence of parent stimulant medication (MED) and behavioral parent training (BPT) on child, maternal, and parenting outcomes among multiplex attention-deficit/hyperactivity disorder (ADHD) families using a pilot Sequential Multiple Assignment Randomized Trial (SMART) design.</p><p><p><b>Methods:</b> To be eligible, mothers had to meet <i>DSM-IV</i> diagnostic criteria for ADHD, and their children had to have elevated ADHD symptoms. Thirty-five mother-child dyads were randomized at baseline and again at week 8. The resulting 4 sequences were MED MED, BPT-BPT, MED-BPT, and BPT MED. Outcomes included child ADHD symptoms, child impairment, maternal ADHD symptoms, and parenting at week 16. Data were collected from September 2012 to December 2016.</p><p><p><b>Results:</b> The BPT-MED sequence demonstrated the most favorable outcomes for child ADHD symptoms (effect size= -0.36) and child impairment (effect sizes -0.33 to -0.51). All 3 sequences involving medication demonstrated similar impact on maternal ADHD symptoms (effect sizes ranged from -0.32 to -0.48). The BPT-MED (effect sizes ranged from 0.30 to 0.35) had the most favorable effects on positive parenting outcomes. For negative parenting outcomes, BPT-MED (effect size= -0.50 for self report) and BPT-BPT (effect size= -0.08 for observation) had the most favorable outcomes.</p><p><p><b>Conclusions:</b> Overall, based on this pilot SMART, combination treatment may be helpful for most multiplex ADHD families, and sequencing treatments with BPT first followed by stimulant medication for the mother may be the most promising approach to improve child ADHD symptoms, impairment, and parenting. These results require replication with a fully powered SMART design. We conclude with considerations for implementing a model of care for multiplex ADHD families.</p><p><p><b>Trial Registration:</b> ClinicalTrials.gov identifier: NCT01816074.</p>","PeriodicalId":50234,"journal":{"name":"Journal of Clinical Psychiatry","volume":"86 1","pages":""},"PeriodicalIF":4.5,"publicationDate":"2025-02-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11947710/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143505725","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Mary Hobart, Denise Chang, Nanco Hefting, Lori L Davis
{"title":"Brexpiprazole in Combination With Sertraline and as Monotherapy in Posttraumatic Stress Disorder: A Full-Factorial Randomized Clinical Trial.","authors":"Mary Hobart, Denise Chang, Nanco Hefting, Lori L Davis","doi":"10.4088/JCP.24m15577","DOIUrl":"10.4088/JCP.24m15577","url":null,"abstract":"<p><p><b>Objective:</b> To investigate the efficacy, safety, and tolerability of brexpiprazole in combination with sertraline and as monotherapy for posttraumatic stress disorder (PTSD).</p><p><p><b>Methods:</b> The trial comprised a 1-week placebo run-in period followed by an 11-week, randomized, double-blind, active-referenced, placebo-controlled, parallel-arm treatment period (with 14-day follow-up). The trial ran from January 2017-November 2018 at 48 clinical trial sites in the United States. Adult outpatients with PTSD (<i>DSM-5</i>) were randomized (1:1:1:1) to oral brexpiprazole + sertraline, brexpiprazole + placebo, sertraline + placebo, or placebo + placebo. Doses were flexible (brexpiprazole 1-3 mg/d; sertraline 100-200 mg/d). The primary endpoint was change in Clinician-Administered PTSD Scale for <i>DSM-5</i> (CAPS-5) total score from randomization (Week 1) to Week 10. Safety assessments included adverse events.</p><p><p><b>Results:</b> Among 321 randomized participants, completion rates were 58/82 (70.7%) for brexpiprazole + sertraline, 50/75 (66.7%) for brexpiprazole +placebo, 59/81 (72.8%) for sertraline + placebo, and 64/83 (77.1%) for placebo+placebo. At Week 10, brexpiprazole + sertraline demonstrated greater improvement in CAPS-5 total score (randomization, 35.7; least-squares [LS] mean change, -16.4; n = 77) vs sertraline + placebo (randomization, 36.5; LS mean change, -11.4; n = 75) with LS mean difference, -5.08 (95% CI, -8.96 to -1.20; <i>P=</i> .011), and also vs brexpiprazole + placebo and vs placebo+ placebo.</p><p><p>Brexpiprazole + placebo and sertraline + placebo did not differ from placebo + placebo. Treatment emergent adverse events with incidence ≥10% were weight increased (12.5%) and somnolence (10.0%) for brexpiprazole + sertraline, akathisia (13.3%) for brexpiprazole + placebo, and nausea (20.3%) and dry mouth (12.7%) for sertraline + placebo.</p><p><p><b>Conclusions:</b> Brexpiprazole in combination with sertraline (but not as monotherapy) has potential to be a new efficacious treatment for PTSD, with a safety profile consistent with brexpiprazole in approved indications.</p><p><p><b>Trial Registration:</b> ClinicalTrials.gov identifier: NCT03033069.</p>","PeriodicalId":50234,"journal":{"name":"Journal of Clinical Psychiatry","volume":"86 1","pages":""},"PeriodicalIF":4.5,"publicationDate":"2025-02-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143505782","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Norman R Greenberg, Florence Yu, Richard A Friedman
{"title":"A Case of Semaglutide-Induced Euphoria in a Patient With Bipolar Disorder.","authors":"Norman R Greenberg, Florence Yu, Richard A Friedman","doi":"10.4088/JCP.25cr15778","DOIUrl":"https://doi.org/10.4088/JCP.25cr15778","url":null,"abstract":"","PeriodicalId":50234,"journal":{"name":"Journal of Clinical Psychiatry","volume":"86 2","pages":""},"PeriodicalIF":4.5,"publicationDate":"2025-02-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143505726","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Maurizio Fava, Luca Pani, Sara De Martin, Andrew J Cutler, Charles W Gorodetzky, Frank J Vocci, Frank L Sapienza, Thomas R Kosten, Cornelia Kröger, Paggard Champasa, Clotilde Guidetti, Stefano Comai, Andrea Mattarei, Franco Folli, David Bushnell, Sergio Traversa, Charles E Inturrisi, Paolo L Manfredi, Marco Pappagallo
{"title":"Long-Term Safety and Efficacy of Esmethadone in Patients With Major Depressive Disorder: Findings From a 12-Month Open-Label Study.","authors":"Maurizio Fava, Luca Pani, Sara De Martin, Andrew J Cutler, Charles W Gorodetzky, Frank J Vocci, Frank L Sapienza, Thomas R Kosten, Cornelia Kröger, Paggard Champasa, Clotilde Guidetti, Stefano Comai, Andrea Mattarei, Franco Folli, David Bushnell, Sergio Traversa, Charles E Inturrisi, Paolo L Manfredi, Marco Pappagallo","doi":"10.4088/JCP.24m15438","DOIUrl":"10.4088/JCP.24m15438","url":null,"abstract":"<p><p><b>Background:</b> Esmethadone is a novel <i>N</i>-methyl-D-aspartate receptor (NMDAR) uncompetitive antagonist in development as adjunctive treatment for major depressive disorder (MDD).</p><p><p><b>Methods:</b> This 12-month, open-label study evaluated the safety and efficacy of esmethadone in patients with MDD meeting <i>DSM-5</i> criteria who completed 1 of 3 double-blind studies (<i>rollover</i>) and in patients with MDD and no prior participation in esmethadone studies (<i>de novo</i>). Safety was assessed from adverse events, laboratory parameters, vital signs, electrocardiogram, and the Columbia-Suicide Severity Rating Scale. Efficacy assessments used measures of depression, anxiety, sleep, sexual function, cognitive function, and quality of life. The safety population comprised patients who received at least 1 dose of study drug, and the full analysis set (FAS) comprised patients who had at least 1 postbaseline efficacy assessment.</p><p><p><b>Results:</b> Safety population included 624 patients; FAS included 586 patients (384 <i>rollover</i> and 202 de novo); mean age was 42.9 (13.6) years, and mean baseline Montgomery-Asberg Depression Rating Scale (MADRS10) was 34.5 (4.8). Most common treatment-related treatment emergent adverse events were headache (4.6%), nausea (4.2%), and dizziness (2.6%). There were no signals of meaningful neurological, cardiovascular, metabolic, or sexual adverse events and no case of suicide or suicidal attempt. For the FAS, mean (SD) change from baseline for MADRS10 at 3, 6, 9, and 12 months was -20.1 (10.7), -21.0 (10.8), -21.6 (10.7), and -21.6 (10.4). For the de novo population, mean (SD) was -19.9 (10.0), -19.9 (10.4), -20.1 (10.2), and -22.5 (9.7). Consistent improvements occurred with other tested efficacy measures.</p><p><p><b>Conclusions:</b> Long-term treatment with esmethadone was safe and well tolerated. The antidepressant efficacy of esmethadone was sustained over 12 months.</p><p><p><b>Trial Registration:</b> ClinicalTrials.gov identifier: NCT04855760.</p>","PeriodicalId":50234,"journal":{"name":"Journal of Clinical Psychiatry","volume":"86 1","pages":""},"PeriodicalIF":4.5,"publicationDate":"2025-02-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143505724","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Target Trial Emulation: A Concept Simply Explained.","authors":"Chittaranjan Andrade","doi":"10.4088/JCP.25f15796","DOIUrl":"10.4088/JCP.25f15796","url":null,"abstract":"<p><p>Target trial emulation (TTE) is an observational, quasi-experimental research design that emulates a randomized clinical trial (RCT) structure within a large set of observational data; the \"target trial\" is a hypothetical RCT that would have ideally answered the research question. TTEs can address study objectives that, for ethical or logistic reasons, cannot easily be examined in RCTs. Advantages of TTEs over conventional approaches to observational data are that TTEs can reduce bias, improve the understanding of findings, and facilitate causal inference. This article explains what TTEs are, how TTEs are performed, and how TTEs differ from observational studies, quasi controlled studies, and RCTs. Prevalent user bias and immortal time bias are explained, as is how TTEs are designed to avoid these biases. Strengths and limitations of TTEs are discussed. This article also presents 2 recent studies: one, comprising 3 TTEs that examined scholastic outcomes in children gestationally exposed to benzodiazepines and z-drugs in different periods during pregnancy; and the other, a TTE that examined manic switch as an outcome in bipolar depression patients who received antidepressant treatment. The TTEs found that early, mid, or late pregnancy exposure to benzodiazepines or z-drugs was not associated with impairment in fifth-grade numeracy and literacy performance; and that, in patients with bipolar depression, antidepressant drugs (with or without concurrent mood stabilizers) did not increase the 1-year risk of hypomania, mania, or mixed episodes, nor did they reduce the risk of recurrence of bipolar depression. The TTEs that yielded these results had limitations, and so these findings are suggestive, not definitive. As a general conclusion, TTEs may be viewed as pragmatic, naturalistic, real-world emulations of RCTs, with some advantages over conventional observational studies, but they cannot drive causal inference.</p>","PeriodicalId":50234,"journal":{"name":"Journal of Clinical Psychiatry","volume":"86 1","pages":""},"PeriodicalIF":4.5,"publicationDate":"2025-02-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143400556","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Correction. Ketamine vs Electroconvulsive Therapy in the Management of Treatment-Resistant Depression: Do We Need More Data?","authors":"","doi":"10.4088/JCP.25lcx15827","DOIUrl":"10.4088/JCP.25lcx15827","url":null,"abstract":"<p><p>This corrects the article DOI: 10.4088/JCP.24br15655.</p>","PeriodicalId":50234,"journal":{"name":"Journal of Clinical Psychiatry","volume":"86 1","pages":""},"PeriodicalIF":4.5,"publicationDate":"2025-02-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143411385","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"The Need for Guidance on Ketamine/Esketamine Use in Real-World Clinical Settings.","authors":"Alina Wilkowska, Wiesław Jerzy Cubała","doi":"10.4088/JCP.24lr15709","DOIUrl":"https://doi.org/10.4088/JCP.24lr15709","url":null,"abstract":"","PeriodicalId":50234,"journal":{"name":"Journal of Clinical Psychiatry","volume":"86 2","pages":""},"PeriodicalIF":4.5,"publicationDate":"2025-02-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143392188","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
David A Bender, Sandeep M Nayak, Joshua S Siegel, David J Hellerstein, Baris C Ercal, Eric J Lenze
{"title":"Psychological Support Approaches in Psychedelic Therapy: Results From a Survey of Psychedelic Practitioners.","authors":"David A Bender, Sandeep M Nayak, Joshua S Siegel, David J Hellerstein, Baris C Ercal, Eric J Lenze","doi":"10.4088/JCP.24m15521","DOIUrl":"10.4088/JCP.24m15521","url":null,"abstract":"<p><p><b>Objective:</b> To assess the viewpoints of psychedelic practitioners in research settings on approaches to psychological support for psychedelic treatments.</p><p><p><b>Methods:</b> An anonymous survey was distributed via email to contacts listed on ClinicalTrials.gov for clinical trials of psilocybin and LSD, personal contacts of authors, and through snowball sampling. The survey included Likert type, multiple choice, free response, and demographic items. Responses to survey items were coded to represent either emotive (emphasizing human and spiritual elements) or neuromodulatory (emphasizing biological drug effects) approaches to psychedelic treatment. Summative scores (\"E-Scores\") were determined to quantitatively represent preferences. Data were collected from March 2023 to July 2023.</p><p><p><b>Results:</b> Forty qualified respondents completed the survey. Respondents came from varying educational backgrounds (42.5% MD/DO and 57.5% other) and practiced in at least 4 countries, 11 U.S. states, and 16 institutions. Respondents had overseen a total of 1,656 psychedelic sessions (average = 41.4). There was a substantial range of response for many items (average range = 84.2% of maximum). Exploratory factor analysis identified 4 latent factors: The Importance of Trust, The Role of Spirituality, Creating an Emotional Setting, and Conceptualizing Negative Experiences. The average respondent held a slight preference for an emotive approach. Respondents who received training at the Multidisciplinary Association for Psychedelic Studies (MAPS) or the California Institute of Integral Studies (CIIS) had significantly greater emotive preference compared to other respondents (<i>P</i> < .05).</p><p><p><b>Conclusions:</b> Among psychedelic researchers, there is no consensus on certain psychological support strategies for psychedelic treatments. There is an aggregate preference for an emotive approach to psychological support, which is higher among individuals receiving training at certain institutions.</p>","PeriodicalId":50234,"journal":{"name":"Journal of Clinical Psychiatry","volume":"86 1","pages":""},"PeriodicalIF":4.5,"publicationDate":"2025-02-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143391902","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Farah Khorassani, Nana Entsuah-Boateng, Michael Sayer, Aya Ozaki
{"title":"Racial Disparities in Mood Stabilizer Prescribing in Mania in Nonpsychotic, Hospitalized Patients With Bipolar I Disorder.","authors":"Farah Khorassani, Nana Entsuah-Boateng, Michael Sayer, Aya Ozaki","doi":"10.4088/JCP.24m15524","DOIUrl":"10.4088/JCP.24m15524","url":null,"abstract":"<p><p><b>Objective:</b> To investigate racial disparities in the first-time prescription of mood stabilizers for first-episode mania in nonpsychotic, hospitalized patients with bipolar I disorder, specifically comparing the rates of lithium and valproic acid prescription between non-Hispanic Black and non-Hispanic White patients.</p><p><p><b>Methods:</b> A retrospective cohort study was conducted using the TriNetX database. We included eligible hospitalized non Hispanic Black and non-Hispanic White patients newly diagnosed with bipolar I disorder without psychotic features between January 1, 2014, and December 31, 2023. Propensity score matching was employed to create balanced comparison populations of non-Hispanic Black and non-Hispanic White patients, controlling for factors that may influence medication selection. A measure of association analysis was performed to calculate and compare the fraction of patients with either lithium or valproic acid use in both cohorts. Odds ratios were assessed.</p><p><p><b>Results:</b> The study included 1,582 patients (N = 791 per cohort). After propensity matching, baseline characteristics were well balanced. Lithium was prescribed to 24% of White patients compared to 15% of Black patients (odds ratio [OR] 1.82, 95% CI, 1.41-2.35, <i>P</i> < .05). Conversely, valproic acid was prescribed to 20% of Black patients compared to 12% of White patients (OR 0.53 95% CI, 0.40-0.71, <i>P</i> < .05).</p><p><p><b>Conclusions:</b> Significant disparities in the prescription rates of valproic acid and lithium were observed, with Black patients more likely to receive valproic acid and less likely to receive lithium compared to their White counterparts. Efforts to address these inequities should involve addressing structural, patient-related, and clinician-related factors that may contribute to our findings.</p>","PeriodicalId":50234,"journal":{"name":"Journal of Clinical Psychiatry","volume":"86 1","pages":""},"PeriodicalIF":4.5,"publicationDate":"2025-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143392080","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Association Between Suicidal Behaviors and Obstructive Sleep Apnea Based on the STOP-Bang Questionnaire: A Nationwide Population-Based Study.","authors":"Chang Hoon Han, Joohyng Son, Jae Ho Chung","doi":"10.4088/JCP.24m15345","DOIUrl":"10.4088/JCP.24m15345","url":null,"abstract":"<p><p><b>Objectives:</b> We studied the association between obstructive sleep apnea (OSA) based on STOP-Bang questionnaire and suicidal risk behaviors (ideations, plans, and attempts) in the general population using a nationally representative sample from South Korea.</p><p><p><b>Methods:</b> Data were obtained from 11,917 adults (aged ≥40 years) who participated in the Korea National Health and Nutrition Examination Survey (2019-2020). Multiple logistic regression analyses were used to evaluate the association between suicidal behaviors and intermediate-high risk OSA (STOP-Bang score ≥3).</p><p><p><b>Results:</b> Poor health status, severe stress, less sleep time, poor quality of life, and depression were significantly more common in the intermediate-high risk OSA group compared to the low risk OSA group. The proportions of the intermediate-high risk OSA group who had suicidal ideation (2.5%), suicidal planning (1.8%), and suicidal attempts (0.5%) were higher than those in the low risk OSA group (1.1%, 1.2%, 0.1%; <i>P</i> < .001, respectively). A multivariate analysis after adjusting revealed that the odds ratios for suicidal ideations, planning, and attempts were 1.42 (95% confidence interval [CI]: 1.00-2.02), 1.21 (95% CI: 1.01-1.77), and 3.29 (95% CI: 1.50-7.24), respectively, in the intermediate-high risk OSA group.</p><p><p><b>Conclusions:</b> Moderate-high risk groups of OSA based on the STOP-Bang questionnaire were associated with suicidal behaviors in a Korean population.</p>","PeriodicalId":50234,"journal":{"name":"Journal of Clinical Psychiatry","volume":"86 1","pages":""},"PeriodicalIF":4.5,"publicationDate":"2025-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143391965","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}