Study: Drug Trials Risky for Patients With Mental Illness
Study Examines Risk of Death in Patients with Psychiatric Illness Participating in Drug Trials
CHICAGO – An analysis of the risk of death among patients with psychiatric illness participating in psychopharmacology clinical trials suggests that overall mortality risk was high and associated with psychiatric diagnosis, especially schizophrenia, depression and bipolar disorder, according to a report published by JAMA Psychiatry, a JAMA Network publication.
Several investigators have raised the possibility that pharmacotherapy may worsen the already increased mortality risk for patients with severe psychiatric illness, according to the study background.
“We undertook this study to find out whether an alternate method of inquiry would confirm previous reports of increased mortality risk in psychiatric patients and to assess whether pharmacotherapy worsens this risk compared with placebo,” Arif Khan, M.D., of the Northwest Clinical Research Center, Bellevue, Wash., and colleagues write in the study.
Researchers reviewed U.S. Food and Drug Administration (FDA) Summary Basis of Approval (SBA) reports for new drug approvals between 1990 and 2011, and 43 reports met researchers’ criteria for evaluation because they used the patient exposure years (PEY) method of assessment. A total of 92,542 patients with psychiatric illnesses participated in clinical trials.
Compared with the general adult population, patients with schizophrenia had the highest mortality risk (3.8-fold increase), followed by patients with depression (3.15-fold increase) and bipolar disorder (3-fold increase). Suicide accounted for 109 of all 265 deaths (41.1 percent), according to the study results.
“Furthermore, three-to-four month exposure to modern psychotropic agents, such as atypical antipsychotic agents, selective serotonin reuptake inhibitors, and selective serotonin-norepinephrine reuptake inhibitors does not worsen this risk. Given the inherent limitations of the FDA SBA reports, further research is needed to support firm conclusions,” the study concludes.
(JAMA Psychiatry. Published online August 28, 2013. doi:10.1001/jamapsychiatry.2013.149. Available pre-embargo to the media at http://media.jamanetwork.com.)
Editor’s Note: Conflict of interest disclosures are detailed in the article. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.
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Posted: August 2013