Depressive Disorder Drug Development Guidance

FDA has issued a draft guidance, Major Depressive Disorder: Developing Drugs for Treatment, to aid sponsors in clinical development of drugs for the monotherapeutic, combination, and adjunctive treatment of major depressive disorder. “Specifically,” the document says, “this guidance addresses FDA’s current thinking regarding the overall development program and clinical trial designs for antidepressant drug products.” The draft is intended to be a focus for continued discussions among the Division of Psychiatry Products, pharmaceutical sponsors, the academic community, and the public.

The guidance does not address bipolar disorder and also does not address development of nonpharmacologic treatments for depression. And it does not contain discussion of the general issues of statistical analysis or clinical trial design.

The draft revises a 9/1977 guidance and will replace that document once the new one is finalized.