Side effects occur without reduction in posttraumatic stress disorder symptoms in veterans
TUESDAY, Aug. 2 (HealthDay News) -- The second-generation antipsychotic risperidone is not an effective treatment for veterans with chronic military-related posttraumatic stress disorder (PTSD) not responding to serotonin reuptake-inhibitors (SRIs) treatment, according to a study published in the Aug. 3 violence/human rights-themed issue of the Journal of the American Medical Association.
John H. Krystal, M.D., from the Veterans Affairs Connecticut Healthcare System in West Haven, and colleagues investigated the efficacy of risperidone as an adjunct to ongoing pharmacologic and psychosocial treatments in 247 veterans with chronic military-related PTSD and ongoing symptoms despite at least two adequate SRI treatments. Between 2007 and 2010, participants were randomly assigned to risperidone (up to 4 mg once daily) or placebo. The primary outcome was the total score on Clinician-Administered PTSD Scale (CAPS). Other scores analyzed included Montgomery-Asberg Depression Rating Scale, Hamilton Anxiety Scale, Clinical Global Impression Scale, and Veterans RAND 36-Item Health Survey.
The investigators found no significant effects of risperidone treatment on the primary outcome measure, with the two groups showing a mean difference of 3.74 in the CAPS score and no significant change in the baseline to 24 weeks' CAPS score (−16.3 and −12.5 in the risperidone and placebo groups, respectively). A mixed model analysis of all time points also showed no significant difference in CAPS score. Risperidone did not reduce symptoms of depression or anxiety nor increase the quality of life. Adverse events, including self-reported weight gain, fatigue, somnolence, and hypersalivation were significantly more common with risperidone than placebo.
"Among patients with military-related PTSD with SRI-resistant symptoms, six-month treatment with risperidone compared with placebo did not reduce PTSD symptoms," the authors write.
Two of the study authors disclosed financial ties to the pharmaceutical industry, including Janssen Pharmaceutica. The study was partially funded by Ortho-McNeil Janssen Scientific Affairs.
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