STAT

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.
The FDA has issued a new draft guidance on antidepressant drug development.

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 In a new draft guidance, the FDA says that patients with a history of suicidal thoughts or behavior “need not be systematically excluded” from clinical trials.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

You’re reading a preview, subscribe to read more.

More from STAT

STAT2 min read
STAT+: Pharmalittle: We’re Reading About Lilly Buying A Plant, A Pfizer Antibiotic, And More
Eli Lilly agreed to acquire a manufacturing facility in Wisconsin from Nexus Pharmaceuticals to produce injectable medicines amid shortages of Mounjaro and Zepbound.
STAT2 min read
STAT+: Pharmalittle: We’re Reading About An OptumRx Contract, 340B Dispute Resolution, And More
Cardinal Health announced its pharmaceutical distribution contracts with UnitedHealth's OptumRx unit will not be renewed after they expire in June.
STAT2 min read
STAT+: Pharmalittle: We’re Reading About CVS And Humira Biosimilars, Schumer’s Broken Insulin Promise, And More
New prescriptions for biosimilar versions of Humira, one of the best-selling drugs in the U.S., surged to 36% from just 5% during the first week of April.

Related Books & Audiobooks