Part A of the study was an open-label design with morning dosing of SAGE-217 for 7 days and included 16 participants, 8 of whom qualified for, and entered, Part B.
Part B had a double-blind, placebo-controlled, randomized withdrawal design with morning dosing for 7 days.
Part C was an open-label design with morning and evening dosing for 14 days and included a different set of 18 participants.
Parts A and B were stopped early (in advance of the planned sample size).
This study was previously posted by Sage Therapeutics. In November 2023, sponsorship of the trial was transferred to Biogen.