Evaluating SAGE-217 for Prevention of Relapse in Adults with MDD
Research type
Research Study
Full title
A phase 3, randomized, double-blind, placebo-controlled study of the efficacy and safety of SAGE-217 with a fixed, repeated treatment regimen on relapse prevention in adults with major depressive disorder
IRAS ID
271446
Contact name
Gillian Andor
Contact email
Sponsor organisation
Sage Therapeutics, Inc
Eudract number
2019-002640-25
ISRCTN Number
ISRCTN00000000
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 3 months, 1 days
Research summary
This trial will investigate the efficacy (effectiveness), long-term safety and tolerability of a fixed, repeated treatment regimen of SAGE-217 of up to a year for preventing relapse in patients with major depressive disorder (MDD) who previously responded to Open-label treatment with SAGE-217.
It is estimated depression affects over 300 million people globally. MDD is diagnosed if a patient expresses at least 5 depressive symptoms out of 9 within a 2 week period. These include depressed mood and/or loss of interest, changes which affect appetite or weight, sleep, psychomotor activity, energy, feelings of guilt, concentration ability and suicidality.
Although antidepressants are the common treatment for depressive disorders, studies have highlighted their limited efficacy, with low remission rates and untreated symptoms. Recent studies suggest a deficit in γ-aminobutyric acid (GABA) plays a role in causing depression and therefore poses an alternative avenue for treatment.
This study will recruit 546 participants at 70 sites around the globe who, at screening; are between 16 and 65 years of age, in good physical health and have experienced 1 major depressive episode (MDE) in the previous 5 years.
Participants will be excluded if they have attempted suicide in the current MDD episode or if they have taken antidepressants within 60 days prior to day 1.The study will consist of 2 stages. Stage 1 will assess response and tolerability over a treatment period of approximately 8 weeks, with participants taking a single dose of the study drug each day alongside food, beginning on day 1 and continuing for 14 consecutive days. Participants who exhibit a response and tolerate the study drug will be eligible for stage 2. During the 40-week stage 2 participants take either study drug or a placebo daily over five 14-day treatment periods, each separated by a 6 week follow up period.
REC name
London - Central Research Ethics Committee
REC reference
19/LO/1728
Date of REC Opinion
9 Dec 2019
REC opinion
Further Information Favourable Opinion