Individuals with posttraumatic stress disorder (PTSD) who took a combination of sertraline and the antipsychotic brexpiprazole showed significantly greater symptom improvement than those who took sertraline plus placebo, according to a study in JAMA Psychiatry.
“The selective serotonin reuptake inhibitors (SSRIs), sertraline and paroxetine, are the only US Food and Drug Administration–approved pharmacotherapies for PTSD,” wrote Lori L. Davis, M.D., of the University of Alabama at Birmingham Heersink School of Medicine, and colleagues. Yet SSRIs aren’t particularly effective for some PTSD symptoms such as hyperarousal, and about 40% of patients do not respond at all, the authors added. “Taken together, this evidence indicates an unmet need for new PTSD treatment options.”
For this clinical trial—supported by Otsuka Pharmaceutical and H. Lundbeck A/S—Davis and colleagues enrolled 450 adults with PTSD of at least six months duration and no comorbid depression. All participants received placebo pills for one week, and those who did not show a strong placebo response were randomly assigned sertraline (150 mg/day) plus brexpiprazole (2-3 mg/day) or sertraline plus placebo for 11 more weeks.
Among the 416 participants (74.5% female) who entered the active-treatment period of the study, those who received sertraline plus brexpiprazole showed a 19.2-point reduction in their PTSD symptoms (assessed with the Clinician-Administered PTSD Scale for DSM-5, or CAPS-5) after nine weeks, compared with a 13.6-point reduction in the sertraline-plus-placebo group. Sertraline plus brexpiprazole was superior to sertraline plus placebo for all four CAPS-5 symptom clusters: intrusive thoughts, avoidance behaviors, arousal, and negative mood.
Participants who took sertraline plus brexpiprazole also showed strong improvements in their depressive symptoms, anxiety symptoms, and psychosocial functioning.
The combination therapy was also well-tolerated, Davis and colleagues noted; the most common treatment-related side effects were nausea and fatigue, and only 4% of participants discontinued due to side effects.
For related information, see the Psychiatric News article, “Guided Anesthetic Injection May Help Patients With PTSD.”
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