November 1st, 2011

Study: Drug does not reduce PTSD severity

A recent study showed that a widely-prescribed medication within the Department of Veterans Affairs used in the treatment of posttraumatic stress disorder did not reduce overall PTSD severity

Risperidone (Risperdal) is the second most widely prescribed second-generation antipsychotic within the VA for PTSD. Two serotonin reuptake inhibitors have FDA approval for the treatment of PTSD, but they appear to be less effective in men than women and less effective in chronic PTSD than acute PTSD, according to the study. Second-generation antipsychotics like Risperidone (which is not approved by the FDA to treat PTSD) are commonly prescribed as an add-on treatment for veterans suffering from chronic PTSD who have not responded to the SRIs.

John H. Krystal, M.D., of the VA Connecticut Healthcare System, was lead author in the study, which appeared in the Journal of the American Medical Association. Participants were all diagnosed with chronic, military-related PTSD, with SRI-resistant symptoms. Patients received Risperidone or placebo, and after six months, no statistically significant difference was found between Risperidone and the placebo in reducing measures of PTSD symptoms or in measures for quality of life, depression and anxiety.

Krystal says the findings may encourage doctors to try other medications that might have a greater chance of being effective and stimulate the field to look for new treatments of PTSD, whether psychosocial or pharmacologic. “So far all of the medications we have to treat PTSD were developed to treat other conditions,” Krystal says. “They were sort of adopted by the doctors treating PTSD. We need to better understand the neurobiology of PTSD so we can use that knowledge to develop more specific treatments.”

Krystal says there are suggestions that Risperidone can be effective for psychosis when in the context of PTSD; and, in the study, it was associated with a reduction in re-experiencing and hyperarousal symptoms associated with PTSD.

But the magnitude of the improvement was small if you compare the placebo group with the group taking the medication, he says. Krystal notes symptoms improved in both groups over the six-month period. “Both patients would say they had a noticeable improvement – it’s just the difference of getting an inactive medication and an active medication wasn’t significant.”

The fact that both groups showed improvement may highlight why Risperidone is still frequently prescribed.

“Doctors do not have the benefit of a placebo comparison,” he sys. “All they have is this experience of taking a pill and seeing if or not (the patient) gets better.

“So that means that in some cases, people who got better got better for other reasons. It highlights one of the differences between research study and clinical practice. In the research study, we can tell the drug is more effective than the placebo but in clinical practice that can be very hard to determine.”

In the study, adverse effects in the Risperidone group included weight gain and fatigue.

Krystal encourages discussion between doctors and patients who fall into this particular category. “In some of these people it would be useful to consider whether a taper of the medication, or even a trial or discontinuation, would be helpful,” Krystal says. “But these kinds of steps need to be taken extremely cautiously, because there are many reasons Risperidone can be helpful.”

By Pamela Berard

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