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Are we cherry picking participants for studies of antidepressants?
Date:4/28/2009

r of the Epidemiology Data Center, University of Pittsburgh Graduate School of Public Health. "This raises major concerns about whether results from traditional phase III studies can be generalized to most people with depression, who also often suffer from anxiety, substance abuse and other medical and psychiatric problems."

When Dr. Wisniewski and colleagues further assessed how well patients did on treatment, they found that those who met the eligibility criteria for phase III trials had better outcomes, including higher remission rates, less severe side effects and serious adverse events. The depression remission rate in the patients who met the criteria was 34.4 percent, compared to only 24.7 percent in the ineligible group. Additionally, the drug response rate also was higher in the eligible group 51.6 percent compared to 39.1 percent of the ineligible group.

"Results from research studies suggest more optimistic outcomes than may exist for real-world patients receiving treatment for depression," said Dr. Wisniewski. Although phase III eligibility criteria could be changed to include a broader population of patients, Dr. Wisniewski cautions that this could come at the cost of more serious side effects in patients who have co-morbidities and are generally sicker. These patients may not be able to safely tolerate the drugs being tested. Instead, he suggests medical care providers who treat patients with depression use their professional judgment by noting that most phase III findings are based on patients who may be very different than those under their care.


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Contact: Clare Collins
CollCX@upmc.edu
412-647-3555
University of Pittsburgh Schools of the Health Sciences
Source:Eurekalert

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