Antidepressant Trials Exclude Vast Majority of Depressed Patients
the Psychiatry Advisor take:
Clinical trials for new antidepressant drugs prevent the vast majority of people with depression from enrolling in them, according to a new study.
Due to strict inclusion and exclusion criteria, more than four out of five of people with depression are deemed ineligible from participating in the trials. However, excluding so many participants from trials may mean that those who are enrolled do not accurately represent “real world” depressed patients.
Sheldon Preskorn, MD and Matthew Macaluso, DO, of the University of Kansas School of Medicine-Wichita, and colleagues analyzed more than 4,000 patients who took part in the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study. STAR*D was the largest and longest study of depression treatment completed in history. And, to make sure that “real world” depressed people were included, the study used minimal exclusion criteria.
However, over 82% of STAR*D patients would be deemed ineligible for new antidepressant trials, according to a list of “usual” inclusion and exclusion criteria, the researchers reported in the Journal of Psychiatric Practice. Fourteen percent would be excluded due to age as the trials don’t enroll adults over 65 years old. And 15% wouldn’t make the cut since their depression wasn’t severe enough, based on enrollment criteria.
“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,” the researchers wrote.
More than 80% of depressed patients would be deemed ineligible for clinical trials of antidepressant drugs due to strict exclusion criteria.
A provocative new study suggests that more than 80% of people with depression in the general population aren't eligible for clinical trials of antidepressant drugs.
Researchers comment that 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).
Drs. Sheldon Preskorn and Matthew Macaluso of University of Kansas School of Medicine-Wichita and Dr. Madhukar Trivedi of Southwestern Medical School in Dallas led the study.
The investigation illuminates some major differences between patients with depression seen in everyday clinical practice and those enrolled in ARTs. This awareness is meaningful as ARTs commonly lead to FDA drug approval for depression medications.