Despite its widespread use in veterans’ facilities, risperidone (Risperdal) appears to be ineffective in the treatment of posttraumatic stress disorder (PTSD) in veterans, according to a new study. Risperdal has not been approved by the U.S. Food and Drug Administration (FDA) to treat PTSD, but doctors often prescribe medications for ailments that have not undergone government approval.
John Krystal, M.D., of the VA Connecticut Healthcare System, and colleagues conducted the six-month, randomized, placebo-controlled multicenter study at 23 different Veterans Administration outpatient medical centers.
Of the 367 patients screened, 296 were diagnosed with military-related PTSD and had ongoing symptoms despite at least two adequate antidepresseant treatments with selective serotonin reuptake inhibitors (SSRIs), and 247 contributed to analysis of the primary outcome measure.
Patients in the study received risperidone (up to 4 mg, once daily) or placebo combined with other therapy. Symptoms of PTSD, depression, anxiety and other health outcomes were gauged via various scales and surveys.
After analysis of the data, the researchers found no statistically significant difference between risperidone and placebo in reducing measures of PTSD symptoms after six months of treatment.
Posttraumatic stress disorder is among the most common and disabling psychiatric disorders among military personnel serving in combat. No psychiatric medication is approved by the FDA to treat it. However, antidepressants are commonly prescribed for some symptoms of PTSD.
Within the U.S. Department of Veterans Affairs (VA), 89 percent of veterans diagnosed with PTSD and treated with pharmacotherapy are prescribed SSRIs, the most common type of antidepressant.
“However, [S]SRIs appear to be less effective in men than in women and less effective in chronic PTSD than in acute PTSD. Thus, it may not be surprising that an SRI study in veterans produced negative results. Second-generation antipsychotics (SGAs) are commonly used medications for SRI-resistant PTSD symptoms, despite limited evidence supporting this practice,” the authors write.
Researchers wondered whether risperidone (Risperdal) added to an ongoing pharmacotherapy regimen would be more effective than placebo for reducing chronic military-related PTSD symptoms among veterans whose symptoms did not respond to at least two adequate SSRI treatments.
The researchers also discovered that risperidone was not statistically superior to placebo on any of the other outcomes, including improvement on measures of quality of life, depression, anxiety, or paranoia/psychosis.
Overall, the rate of adverse events during treatment was low but appeared related to dosing of risperidone.
“In summary, risperidone, the second most widely prescribed second-generation antipsychotic within VA for PTSD and the best data-supported adjunctive pharmacotherapy for PTSD, did not reduce overall PTSD severity, produce global improvement, or increase quality of life in patients with chronic SRI-resistant military-related PTSD symptoms.
“Overall, the data do not provide strong support for the current widespread prescription of risperidone to patients with chronic [S]SRI-resistant military-related PTSD symptoms, and these findings should stimulate careful review of the benefits of these medications in patients with chronic PTSD,” the authors conclude.
In treating military-related PTSD, Charles W. Hoge, M.D., of the Walter Reed Army Medical Center, writes that “significant improvements in population care for war veterans will require innovative approaches to increase treatment reach.”
“Research is required to better understand the perceptions war veterans have concerning mental health care, acceptability of care, willingness to continue with treatment, and ways to communicate with veterans that validate their experiences as warriors.”
The study appears in the August 3 issue of the Journal of the American Medical Association.