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Brexpiprazole and Sertraline Combination Treatment Improves PTSD Symptoms

Combining brexpiprazole and sertraline in treatment of post-traumatic stress disorder (PTSD) significantly improved PTSD symptoms when compared with sertraline and placebo treatment, according to results from a randomized clinical trial published in JAMA Psychiatry. 

“Brexpiprazole plus sertraline was also associated with improvements in depression, anxiety, and psychosocial functioning,” authors noted. “A low rate of discontinuation due to adverse events indicated that brexpiprazole plus sertraline treatment was tolerated by most participants. Overall, this trial demonstrated the utility of the combination of brexpiprazole plus sertraline as a new efficacious treatment for PTSD.”

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The parallel-design, double-blind, randomized clinical trial was conducted from October 2019 to August 2023 at 86 sites across the US. After a 1-week placebo run-in, 11 weeks of treatment were administered to adult outpatients with PTSD using brexpiprazole (2-3 mg/day, flexible dose) and sertraline (150 mg/day), or sertraline (150 mg/day) and placebo in a 1:1 ratio. The primary outcome was the change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total scores from randomization (week 1) to week 10, measuring PTSD symptom severity. Safety was assessed by monitoring adverse events.

A total of 416 participants were included in the study (mean age, 37.4 years; 74.5% female). Of those, 137 of 214 participants (64.0%) in the brexpiprazole and sertraline group and 113 of 202 participants (55.9%) in the sertraline and placebo group completed the study. At week 10, combining brexpiprazole and sertraline demonstrated statistically significant, greater improvement in CAPS-5 total score (mean [SD] at randomization, 38.4 [7.2]; LS mean [SE] change, −19.2 [1.2]; n = 148) than sertraline and placebo (randomization, 38.7 [7.8]; change, −13.6 [1.2]; n = 134), with LS mean difference, −5.59 (95% CI, −8.79 to −2.38; P < .001). 

Treatment-emergent adverse events with incidence of 5% or greater for brexpiprazole and sertraline (and corresponding incidences for sertraline and placebo) were nausea (25 of 205 [12.2%] and 23 of 196 [11.7%]), fatigue (14 of 205 [6.8%] and 8 of 196 [4.1%]), weight increase (12 of 205 [5.9%] and 3 of 196 [1.5%]), and somnolence (11 of 205 [5.4%] and 5 of 196 [2.6%]). In the brexpiprazole and sertraline group, 8 participants discontinued due to adverse events (3.9%) and 20 discontinued in the control group (10.2%)

Authors noted that possible limitations of this study include the patient eligibility criteria, restrictions on concomitant therapy, and the lack of non-US sites, limiting generalizability of results.

 

Reference
Davis LL, Behl S, Lee D, et al. Brexpiprazole and sertraline combination treatment in posttraumatic stress disorder: a phase 3 randomized clinical trial. JAMA Psychiatry. Published online December 18, 2024. doi:10.1001/jamapsychiatry.2024.3996