Finally, a New Option for Posttraumatic Stress Disorder?

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Finally, a New Option for Posttraumatic Stress Disorder?
Post-Traumatic Stress DisorderPost-Traumatic Stress SyndromePosttraumatic Stress Disorder
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A drug that combines an atypical antipsychotic and an SSRI is under FDA review, and if approved will be the first FDA-approved medication for PTSD in more than 20 years.

A drug that combines the atypical antipsychotic brexpiprazole and the selective serotonin reuptake inhibitor sertraline provides significantly greater relief of posttraumatic stress disorder symptoms than sertraline plus placebo, results of a phase 3 trial showed.

“And what is really cool, what’s really impactful is the combination worked better than sertraline plus placebo on a brief inventory of psychosocial functioning,” study investigator Lori L.

“New medications that might address the important ‘effectiveness gap’ in PTSD could help to reduce the remaining distress, disability, and suicide risk associated with PTSD.” included 416 adults aged 18-65 years with a DSM-5 diagnosis of PTSD and symptoms for at least 6 months prior to screening. Patients underwent a 1-week placebo-run in period followed by randomization to daily oral brexpiprazole 2-3 mg plus sertraline 150 mg or daily sertraline 150 mg plus placebo for 11 weeks.

At the last visit, the mean change in body weight from baseline was an increase of 1.3 kg for brexpiprazole plus sertraline vs 0 kg for sertraline alone. Rates of fatigue and somnolence were also higher with brexpiprazole plus sertraline.“We’ve looked at that data and the sertraline/placebo response was a lot higher, so it was not due to a lack of response with the combination but due to a more robust response with the active control,” Davis said.

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Post-Traumatic Stress Disorder Post-Traumatic Stress Syndrome Posttraumatic Stress Disorder Post-Traumatic Stress Disorder (PTSD) U.S. Food And Drug Administration United States Food And Drug Administration FDA Food And Drug Administration (FDA) Food And Drug Administration Atypical Antipsychotics Second Generation Antipsychotics Stress Antipsychotics Neuroleptics

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