What the trial was testing
The trial enrolled 102 patients with depression. The study was sponsored by Biogen and tracked outcomes across the full group of patients who matched the trial's eligibility profile.
It was initial testing (phase 2). Trials at this stage are designed to produce evidence regulators and physicians can act on — not just observations to follow up later.
What the results showed
Depression scores dropped 7 points more with SAGE-217 than placebo after two weeks.
The New England journal of medicine · 2019 · NCT03000530
These findings — that depression symptom scores improved 7 points more with the medication than placebo — were published in the The New England journal of medicine and represent the headline result of the study.
Researchers tracked outcomes across 102 patients enrolled in the trial. The result was consistent enough across the group that the team felt confident reporting it.
What this means for patients
For patients with depression, this result changes the calculus on what to ask their care team about. Whether it changes day-to-day care depends on factors like disease subtype, prior treatments, and where the patient is in their care journey.
What you can do now
This was an initial testing study and SAGE-217 is not yet FDA-approved for depression. The trial was small and only lasted two weeks, so doctors need more information about long-term safety and how it compares to existing antidepressants. Talk to your doctor about approved depression treatments and whether any trials for similar medications are enrolling.
Eligibility for the treatments mentioned above depends on specific test results and clinical history. Bring this summary, the trial name, and your most recent labs or pathology report to your next visit.
Open depression trials
Creating Health Course Study for People With Rheumatological Conditions and Mood Disorders
The goal of this project is to critically evaluate the effectiveness of an online health program designed to improve diet and self-care in patients with rheumatological conditions, including rheumatoid arthritis (RA), Sjogren's syndrome (SS), systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), psoriatic arthritis (PsA), anxiety disorders, depressive disorders and moderate depression. Additionally, investigators will assess the program's effectiveness, as well as the challenges and facilitators involved in using an online wellness program to reduce fatigue and enhance the quality of life in patients suffering from these conditions.
Activating Social Resources in Psychotherapy-Seeking Individuals: Effectiveness and Timing of a Social Support Just-in-Time Adaptive Intervention
This study evaluates a Just-In-Time Adaptive Intervention (JITAI) aiming to foster social support processes for adults with elevated depressive symptoms awaiting outpatient psychotherapy. Utilizing a daily-level micro-randomized trial (MRT) design conducted over 21 days, participants are assessed six times daily. Participants are randomized across four conditions: (1) vulnerability-triggered, (2) vulnerability and receptivity-triggered, (3) support-need-triggered, and (4) a no-intervention control. The primary objective of this study is to evaluate the effectiveness of the JITAI in reducing daily depressive symptoms and increasing received social support (primary outcomes), as well as reducing daily loneliness and enhancing perceived social support (secondary outcomes). Furthermore, the study aims to compare the relative efficacy of three distinct triggering strategies to identify the most effective timing for intervention delivery.