Patients with suicidal thoughts can be included in depression clinical trials, FDA says


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 In a new draft guidance, the FDA says that patients with a history of suicidal thoughts or behavior “need not be systematically excluded” from clinical trials.

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.

Related article:  Why lumping transgender teens into a single group in mental health studies is missing an opportunity to help them

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.

“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

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