Keypoint: A poster at the 2024 ASCP Annual Meeting shared data from 3 randomized clinical trials on the safety and tolerability of this treatment combination.
CONFERENCE REPORTER
A poster at the 2024 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting shared an analysis of safety data from 3 clinical trials exploring the safety and efficacy of a combination therapy of brexpiprazole and sertraline in the treatment of posttraumatic stress disorder (PTSD).
The 3 trials aimed to evaluate the safety and efficacy of brexpiprazole combined with sertraline for the treatment of PTSD.1 These trials included Trial 0612 (Phase 2; NCT03033069), Trial 0713 (Phase 3; NCT04124614), and Trial 0724 (Phase 3; NCT04174170). In all of the trials, participants were male and female outpatients aged 18 to 65 years who had received a DSM-5 diagnosis of PTSD and had experienced symptoms for at least 6 months. Each trial involved an 11-week randomized, double-blind phase.
Trial 061 randomized patients into 4 groups: brexpiprazole (1 to 3 mg/day) with sertraline (100 to 200 mg/day), brexpiprazole with placebo, sertraline with placebo, and placebo. Trial 071 compared brexpiprazole (2 to 3 mg/day) with sertraline (150 mg/day) against sertraline with placebo. And Trial 072 tested 3 groups: brexpiprazole (2 mg/day) with sertraline (150 mg/day), brexpiprazole (3 mg/day) with sertraline, and sertraline with placebo.
The primary endpoint for these studies was the change in the Clinician Administered PTSD Scale for DSM-5 (CAPS-5) total score from baseline to week 10. Safety assessments included treatment-emergent adverse events (TEAEs), changes in body weight, incidence of suicidality, and deaths.
Results showed that the incidence of TEAEs varied across the trials. In Trial 061 (n=316), TEAEs were reported in 72.5% of the brexpiprazole plus sertraline group, 70.7% in the brexpiprazole plus placebo group, 69.6% in the sertraline plus placebo group, and 78.0% in the placebo group. In Trial 071 (n=401), 60.0% in the brexpiprazole plus sertraline group experienced TEAEs compared with 58.2% in the sertraline plus placebo group. In Trial 072 (n=537), TEAEs were 51.4% in the brexpiprazole 2 mg/day plus sertraline group, 48.3% in the brexpiprazole 3 mg/day plus sertraline group, and 51.2% in the sertraline plus placebo group.
When data from the 3 studies were pooled, the overall incidence of TEAEs was similar between the brexpiprazole plus sertraline group (55.5%) and the sertraline plus placebo group (56.2%). Common TEAEs included nausea, headache, weight gain, and diarrhea. Notably, weight gain was more common in the brexpiprazole plus sertraline group (5.2%) compared with the sertraline plus placebo group (1.3%).
The mean change in body weight from baseline to week 12 was an increase of 1.5 kg for the brexpiprazole plus sertraline group, whereas the sertraline plus placebo group saw a slight decrease of 0.2 kg. The incidence of suicidality-related TEAEs was lower in the brexpiprazole plus sertraline group (0.6%) compared with the sertraline plus placebo group (1.1%). Three deaths occurred across the studies, each in different treatment arms, but none were deemed related to the study treatments.
The investigators concluded that the combination of brexpiprazole and sertraline appears to be safe and well-tolerated in patients with PTSD, with no new safety concerns emerging from the trials. They added that this combination therapy holds potential as a new treatment option for PTSD, subject to confirmation of its efficacy.
Note: This article originally appeared on Psychiatric Times
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