Depression and antidepressant drugs

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Antidepressant trials exclude most 'real world' patients with depression

More than 80 percent of people with depression in the general population aren't eligible for clinical trials of antidepressant drugs.

At least five patients would need to be screened to enroll just one patient meeting the typical inclusion and exclusion criteria for antidepressant registration trials (ARTs), suggests the new research by Drs. Sheldon Preskorn and Matthew Macaluso of University of Kansas School of Medicine-Wichita and Dr. Madhukar Trivedi of Southwestern Medical School, Dallas. The study highlights some major differences between patients with depression seen in everyday clinical practice and those enrolled in ARTs--the studies of antidepressants that lead to FDA drug approval.

The researchers hope their work will help drug developers understand how inclusion and exclusion criteria may affect enrollment in ARTs, and help them in developing an appropriate recruitment plan and timeline. "The timelines in most drug studies are unrealistically short and their recruitment plans are often woefully inadequate, resulting in studies that take longer than expected to complete and frequent budget overruns," Drs. Preskorn, Macaluso, and Trivdei write. Failure to consider the effort needed for ART recruitment might lead to lost revenue, delays in bringing a drug to market, or failure to develop a potentially effective medication.

The findings may also help to explain to healthcare practitioners why ARTs tend to overestimate the benefits of antidepressant treatment in "real world" patients with depression. "Obviously," the researchers add, "the more patients who are excluded from the ARTs, the greater the chances that the results will not generalize to the routine clinical practice."

Journal of Psychiatric Practice




















Depression and antidepressant drugs

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