CompletedPhase 2

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

United States35 participantsStarted 2018-08-23

Plain-language summary

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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. Participant had a history of suicide attempt.
. Participant had current suicidal ideation with plans.
. Participant had a history of rapid cycling bipolar disorder.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Part A: Number of Participants With at Least One Treatment-Emergent Adverse Events (TEAEs)

Timeframe: From first dose of study drug up to Day 42

Part A: Number of Participants With TEAEs, Graded by Severity

Timeframe: From first dose of study drug up to Day 42

Part A: Percentages of Participants With Response to Suicidal Ideation and Suicidal Behavior Based on the Columbia-Suicide Severity Rating Scale (C-SSRS)

Timeframe: Baseline, Post-baseline (any time up to Day 42)

Part A: Change From Baseline in the Young Mania Rating Scale (YMRS) Total Score

Timeframe: Baseline, Days 3, 8, 12, 15, 21, 28, 35, and 42, Last value on treatment (up to Day 14), Last value on study (up to Day 42)

Part B: Change From Baseline in the 17-Item Hamilton Depression Rating Scale (HAM-D) Total Score

Timeframe: Baseline up to Day 42

Trial details

NCT IDNCT03692910

SponsorBiogen

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-05-21

Results submitted2022-03-23

View on ClinicalTrials.gov More Bipolar Disorder I trials

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. Participant had a history of suicide attempt.
. Participant had current suicidal ideation with plans.
. Participant had a history of rapid cycling bipolar disorder.

What they're measuring

Part A: Number of Participants With at Least One Treatment-Emergent Adverse Events (TEAEs)

Timeframe: From first dose of study drug up to Day 42

Part A: Number of Participants With TEAEs, Graded by Severity

Timeframe: From first dose of study drug up to Day 42

Part A: Percentages of Participants With Response to Suicidal Ideation and Suicidal Behavior Based on the Columbia-Suicide Severity Rating Scale (C-SSRS)

Timeframe: Baseline, Post-baseline (any time up to Day 42)

Part A: Change From Baseline in the Young Mania Rating Scale (YMRS) Total Score

Timeframe: Baseline, Days 3, 8, 12, 15, 21, 28, 35, and 42, Last value on treatment (up to Day 14), Last value on study (up to Day 42)

Part B: Change From Baseline in the 17-Item Hamilton Depression Rating Scale (HAM-D) Total Score

Timeframe: Baseline up to Day 42