Antidepressant trials often exclude individuals with suicidality
Individuals with suicidality often are excluded from antidepressant trials, which creates uncertainty about medication efficacy and safety in segments of the target population, according to study findings published in Journal of Clinical Psychiatry.
“Prescribers face significant uncertainty regarding the effectiveness of many antidepressants in suicidal patients,” Ana S. Iltis, PhD, director of the Center for Bioethics, Health and Society at Wake Forest University in North Carolina, told Healio Psychiatry. “Clinicians who treat depressed patients with suicidal ideation or prior suicide attempts ideally should favor antidepressant medications with documented efficacy for suicidal ideation and behavior.”
Many studies have documented health inequities in different populations, including individuals with mental health disorders. Inequities may be a result of exclusion from biomedical research, as well as underreporting of the exclusion and inclusion criteria and enrolled participants’ relevant characteristics. This underreporting masks information about the applicability of results to the target population, the researchers wrote.
Iltis and colleagues gained insight into the underrepresentation of those with suicidality in clinical trials by documenting their exclusion from trials used to secure FDA approval for antidepressants, as well as describing barriers to inclusion and identifying potential steps for overcoming barriers. Specifically, they read the FDA labels for 14 antidepressants approved between 1991 and 2013, publications described on labels and ClinicalTrials.gov entries for registered labels to assess inclusion and exclusion criteria for efficacy trials for major depressive disorder or depression.
Of 36 publications for drugs approved from 1991 to 2000, 26 did not mention suicidality, seven excluded individuals with suicidality but did not describe using an instrument to assess suicidality, two excluded individuals with suicidality and described using at least one instrument to assess suicidality, and one included individuals with suicidality. Of 28 publications identified for drugs approved from 2000 to 2013, four did not mention suicidality, 12 excluded individuals with suicidality but did not describe using an instrument to assess suicidality, 12 excluded individuals with suicidality and described using at least one instrument to assess suicidality, and none included individuals with suicidality.
Iltis and colleagues noted that more stringent criteria for assessment and exclusion based on suicidality were likely applied for drugs approved after 2000.
“I suspect this is the tip of the iceberg and only one example of a category of medications for which the results are not truly generalizable to the target population — the range of patients likely to be prescribed those medications,” Iltis told Healio Psychiatry. “There is much room for improvement in clinical research.” – by Joe Gramigna
Disclosures: Iltis reports no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.