Mary Hobart, Denise Chang, Nanco Hefting, Lori L Davis
{"title":"Brexpiprazole联合舍曲林单药治疗创伤后应激障碍：一项全因子随机临床试验。","authors":"Mary Hobart, Denise Chang, Nanco Hefting, Lori L Davis","doi":"10.4088/JCP.24m15577","DOIUrl":null,"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":4.5000,"publicationDate":"2025-02-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"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\":null,\"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. 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Brexpiprazole in Combination With Sertraline and as Monotherapy in Posttraumatic Stress Disorder: A Full-Factorial Randomized Clinical Trial.
Objective: To investigate the efficacy, safety, and tolerability of brexpiprazole in combination with sertraline and as monotherapy for posttraumatic stress disorder (PTSD).
Methods: 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 (DSM-5) 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 DSM-5 (CAPS-5) total score from randomization (Week 1) to Week 10. Safety assessments included adverse events.
Results: 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; P= .011), and also vs brexpiprazole + placebo and vs placebo+ placebo.
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.
Conclusions: 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.
期刊介绍：
For over 75 years, The Journal of Clinical Psychiatry has been a leading source of peer-reviewed articles offering the latest information on mental health topics to psychiatrists and other medical professionals.The Journal of Clinical Psychiatry is the leading psychiatric resource for clinical information and covers disorders including depression, bipolar disorder, schizophrenia, anxiety, addiction, posttraumatic stress disorder, and attention-deficit/hyperactivity disorder while exploring the newest advances in diagnosis and treatment.
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