Review Says Depression Standard of Care Needs Reappraisal

July 19, 2010

Review calls for reappraisal of Depression Standard of Care

Following the review of four meta-analyses of efficacy trials submitted to the FDA, as well as the largest antidepressant effectiveness trial ever, STAR*D (Sequenced Treatment Alternatives to Relieve Depression), researchers from NeuroAdvantage, LLC, Clarksvilled, MD, and the Department of Psychology, American University, Washington, DC, have concluded that their findings “argue for a reappraisal of the current recommended standard of care of depression.”

Looking at the meta-analyses of FDA trials, the researchers determined that, collectively, they suggested that “antidepressants are only marginally efficacious compared to placebos and document profound publication bias that inflates their apparent efficacy.” The team also wrote that the four meta-analyses “document a second form of bias in which researchers fail to report the negative results for the pre-specified primary outcome measure submitted to the FDA, while highlighting in published studies positive results from a secondary or even a new measure as though it was their primary measure of interest.”

In analyzing STAR*D, the team found that the study authors reported modest levels of antidepressant therapy effectives that were probably even higher than in actuality, “with an apparent progressively increasing dropout rate across each study phase.”

Read the full review on the Psychotherapy and Psychosomaticswebsite.

Learn more about the meta-analyses and STAR*D

  • Reporting Bias in Drug Trials Submitted to the Food and Drug Administration: A Review of Publication and Presentation
  • Selective Publication of Antidepressant Trials and Its Influence on Apparent Efficacy
  • The Emperor’s New Drugs: An Analysis of Antidepressant Medication Data Submitted to the U.S. Food and Drug Administration
  • Can Phase III Trial Results of Antidepressant Medications Be Generalized to Clinical Practice? A STAR*D Report