Patients who have had suicidal thoughts are often excluded from antidepressant trials. The FDA says they don’t need to be
The FDA is making clear that patients with a history of suicidal thoughts or behaviors can be included in clinical trials.
by Megan Thielking
Jun 28, 2018
4 minutes
The Food and Drug Administration is overhauling its guidance for developing treatments for major depressive disorder for the first time since 1977 — and this time around, it’s making clear that patients with a history of suicidal thoughts or behaviors can be included in clinical trials.
Drug companies often rule out potential research participants with a recent history of suicidal thoughts or behavior, citing safety concerns or other issues. In a new draft guidance, the FDA says that patients with a history of suicidal thoughts or behavior “need not be systematically excluded” from clinical trials.
“Although this [exclusion] has been and is acceptable, we would encourage
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