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 In a new draft guidance, the FDA says that patients with a history of suicidal thoughts or behavior “need not be systematically excluded” from clinical trials.
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Excluding patients who’ve had suicidal thoughts or have attempted suicide leaves patients and clinicians in a bind: They can’t be certain the drugs will work for patients most in need of more effective treatments at a time when the U.S. suicide rate is climbing.
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Experts point to several reasons drug companies might be reluctant to include such patients in their trials, including liability. Drug companies wouldn’t want to be blamed if a patient dies by suicide during a clinical trial.
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“I feel the ethics dictate we study [depression] more. These illnesses kill people. And we’re losing a lot of people because we don’t have more effective treatments,” said [Dr. John] Greden.
Read full, original post: Patients who have had suicidal thoughts are often excluded from antidepressant trials. The FDA says they don’t need to be
