Study: Common Medication Given for PTSD Has No Benefit

by U.S. Medicine

September 7, 2011

WASHINGTON — An antipsychotic medication commonly used by VA to treat combat-related PTSD has been found to have no discernible benefit. Patients taking the drug risperidone (Risperdal) did no better than those taking a placebo, according to a recent VA-run study.

Veterans’ advocates expressed dismay that patients were being given medication that was “pretty much useless.”

Second-Line Drug

Currently, selective serotonin reuptake inhibitors (SSRIs) such as Paxil and  Zoloft, are the only FDA-approved medications for PTSD. They primarily affect the neurotransmitter serotonin, which helps regulate mood, anxiety, sleep and other body functions. A number of controlled trials have shown these drugs to be effective in treating PTSD, and they remain the preferred first-line pharmaceuticals in treatment. Smaller trials have also been conducted on newer antidepressants in treating PTSD and in treating the comorbid major depressive disorder that frequently accompanies PTSD.

However, even the FDA-approved SSRIs have shown minimal impact on chronic PTSD, so many VA patients do not respond to SSRI therapy or have residual symptoms following the use of SSRIs. In these cases, physicians may turn to atypical antipsychotics, such as Risperdal.

Risperdal has been found successful in treating schizophrenia, bipolar disorder and some of the symptoms of autistic disorder. The drug acts primarily on the dopaminergic and serotonergic systems and is commonly used to treat behavior problems such as aggression, self-injury and sudden mood changes seen in autistic teenagers and children.

It and other second-generation antipsychotics have been used also by VA physicians as adjunctive therapy for PTSD patients who did not respond to first-line medications. Doctors believed it could improve the hyperarousal and re-experiencing symptoms of PTSD in the same way it improved other behavioral problems.

Prior to this most recent study, there was one positive trial for risperidone as monotherapy. That trial looked at women with PTSD related to sexual assault and domestic abuse. There also were three positive trials and two negative trials of risperidone as adjunctive therapy. Most of these were in veterans with combat-related PTSD.

Nearly 87,000 VA patients suffering from PTSD — approximately 20% of VA’s total number of PTSD patients — were prescribed an antipsychotic in 2009.

Study: Common Medication Given for PTSD Has No Benefit Cont.

Failure to Respond

To better determine whether atypical antipsychotics were truly effective in treating PTSD, researchers at the VA Connecticut Healthcare System looked at 267 PTSD patients spread across 23 facilities. The patients all had Clinician-Administered PTSD Scale (CAPS) scores of greater than 50, had failed to respond to at least two antidepressants and were not responding to SSRI treatments.

The patients were randomized for either risperidone as adjunctive therapy or placebo for six months. Researchers then examined the patients’ CAPS scores. The results showed a CAPS score decline of 16.3 points in the risperidone group and 12.5 points in the placebo group. The difference of four points was not statistically significant, the researchers said.

Looking at secondary outcomes, such as anxiety levels and quality of life, they found no significant difference between the two groups. The biggest difference between the two groups was in adverse events, with weight gain, fatigue, somnolence and hypersalivation occurring at a much greater frequency in the risperidone section. The study was published in the August 3 issue of the Journal of the American Medical Association.

These latest findings have veterans’ advocates worried that VA is relying on unproven medications and that the end result will be a further erosion of trust between veterans and the department.

“I am greatly concerned that veterans suffering the ‘invisible wounds of war’ are receiving equally invisible care,” said Jimmie Foster, national commander of the American Legion. Foster expressed concern that, not only is Risperdal not approved by the FDA for treating PTSD, but also the approved drugs are not very effective against chronic PTSD.

“It is alarming that fully 20% of the [veterans] treated for PTSD last year were given a medication that has proven to be pretty much useless,” he said.

Last year, the American Legion created an informal committee to investigate the efficacy of existing treatments for PTSD and TBI. High on the list of the committee’s concerns is the misapplication of medications to treat PTSD and the overall lack of effective medications. The Legion will advocate for congressional hearings into the problems VA and DoD have experienced treating PTSD and for VA to speed up research into screening and treatment.

Currently, Risperdal remains on VA’s list of recommended medications to treat PTSD. According to VA officials, the department may be undertaking a review of its use in the near future. However, VA must conduct a policy review prior to any dissemination of any new recommendations.

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