Trial reportJournal of clinical psychopharmacology
Fixed-Dose Brexpiprazole and Sertraline Combination Therapy for the Treatment of Posttraumatic Stress Disorder: A Phase 3, Randomized Trial.
Trial report in Journal of clinical psychopharmacology. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04174170 (A Phase 3, Multicenter, Randomized, Double-blind Trial of Fixed-Dose Brexpiprazole as Combination Therapy With Sertraline in the Treatment of Adults With Post-traumatic Stress Disorder), which is not on this map. Not yet cited in PubMed.
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The trial behind it
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A Phase 3, Multicenter, Randomized, Double-blind Trial of Fixed-Dose Brexpiprazole as Combination Therapy With Sertraline in the Treatment of Adults With Post-traumatic Stress Disorder
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Authors and funding
9 authors.
Funding
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Abstract
purposeThis trial aimed to investigate the efficacy, safety, and tolerability of fixed-dose brexpiprazole in combination with sertraline for posttraumatic stress disorder (PTSD).
methodsThis was a phase 3, randomized, parallel-arm trial in adult outpatients with PTSD, across 95 sites in the United States (ClinicalTrials.gov: NCT04174170). After a 1-week placebo run-in, participants entered 11 weeks of randomized (1:1:1) double-blind treatment with brexpiprazole 2 mg/d+sertraline 150 mg/d, brexpiprazole 3 mg/d+sertraline 150 mg/d, or sertraline 150 mg/d+placebo (active control). The primary endpoint was the change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total score from randomization (week 1) to week 10. Safety was also assessed.
findingsThe trial (October 2019 to August 2023) screened 1821 participants, and randomized 553 (brexpiprazole 2 mg+sertraline, n=191; brexpiprazole 3 mg+sertraline, n=185; and sertraline+placebo, n=177). All groups showed CAPS-5 total score reductions [LS mean (SE) change at week 10: brexpiprazole 2 mg+sertraline, -16.5 (1.2), n=132; brexpiprazole 3 mg+sertraline, -18.3 (1.2), n=124; and sertraline+placebo, -17.6 (1.2), n=130]. LS mean differences (95% CI) versus sertraline+placebo at week 10: brexpiprazole 2 mg+sertraline, 1.03 (-2.09 to 4.16), P =0.52; brexpiprazole 3 mg+sertraline, -0.71 (-3.88 to 2.46), P =0.66. Treatment-emergent adverse events with incidence ≥5% for either brexpiprazole+sertraline group were headache (brexpiprazole 2 mg+sertraline, 7.0%; brexpiprazole 3 mg+sertraline, 5.6%; and sertraline+placebo, 7.6%), nausea (4.9%; 8.3%; 8.7%), and diarrhea (3.8%; 6.1%; 6.4%).
conclusionsPTSD symptom improvement was similar with fixed-dose brexpiprazole+sertraline and sertraline+placebo; the primary endpoint was not met. This differs from 2 prior trials that showed greater efficacy for brexpiprazole+sertraline versus sertraline+placebo. No new safety signals were observed.
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