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Completed Phase 2 Interventional Results available

A Study to Evaluate SAGE-217 in Participants With Bipolar I/II Disorder With a Current Major Depressive Episode

ClinicalTrials.gov ID: NCT03692910

Public ClinicalTrials.gov record NCT03692910. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 30, 2026, 3:11 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A 2-Part Study (Open-label Followed by Double-blind, Randomized, Placebo-controlled, Parallel Group) of the Safety, Tolerability, Pharmacokinetics, and Efficacy of SAGE-217 in the Treatment of Subjects With Bipolar I/II Disorder With a Current Major Depressive Episode

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This is an open-label study evaluating the safety, tolerability, pharmacokinetics, and efficacy of SAGE-217 in the treatment of participants with bipolar I/II disorder with a current major depressive episode.

Study identification

NCT ID
NCT03692910
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Biogen
Industry
Enrollment
35 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 65 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 23, 2018 (Actual)
Primary completion
May 21, 2019 (Actual)
Completion
May 21, 2019 (Actual)
Last update posted
Dec 13, 2023

2018 – 2019

United States locations

U.S. sites
11
U.S. states
6
U.S. cities
11
Facility City State ZIP Site status
Sage Investigational Site Little Rock Arkansas 72211 —
Sage Investigational Site Garden Grove California 92845 —
Sage Investigational Site Lemon Grove California 91945 —
Sage Investigational Site Orange California 92868 —
Sage Investigational Site Jacksonville Florida 32256 —
Sage Investigational Site Lauderhill Florida 33319 —
Sage Investigational Site Orlando Florida 32801 —
Sage Investigational Site Decatur Georgia 30030 —
Sage Investigational Site St Louis Missouri 63141 —
Sage Investigational Site Austin Texas 78754 —
Sage Investigational Site Richardson Texas 75080 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03692910, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 13, 2023 · Synced Oct 30, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03692910 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →