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CompletedNCT03692910

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

This study evaluated the safety and effectiveness of SAGE-217 for people with bipolarity.

Medication studyAges 18–65United States
The study in practice

Understand this study

What did researchers investigate?

This study evaluated the safety and effectiveness of SAGE-217 for people with bipolarity.

Who was this study for?

This study was for people with type I bipolarity. Listed age limits: 18 years to 65 years. Other eligibility criteria applied.

Listed locations
Little Rock and 10 more locationsSee all locations and recruitment
Study phase
Phase 2Usually explores whether the intervention may work, while continuing to monitor safety.
Study clarity

Study information

Study start dateStarted: August 23, 2018
Recruitment status
Completed
Enrollment listed in the registry
35
Sponsor
Biogen
Sponsor type
Unknown or unclear
Study type
Drug
Intervention type
Medication / drug
Study phase
Phase 2Usually explores whether the intervention may work, while continuing to monitor safety.
Locations
United States
Age range
From 18 Years to 65 Years
Official registry ID
NCT03692910
Official title
Show the full 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

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Recruitment & locations

Completed

Little Rock · Garden Grove · Lemon Grove

8 more locations
  • Orange
  • Jacksonville
  • Lauderhill
  • Orlando
  • Decatur
  • St Louis
  • Austin
  • Richardson
FAQ

Questions about this study

What did researchers investigate?

This study evaluated the safety and effectiveness of SAGE-217 for people with bipolarity.

Who is behind this study?

The study sponsor is Biogen.

Did this study involve medication?

Yes. The study involved medication, including SAGE-217 and Placebo.

Who was this study for?

This study was for people with type I bipolarity. Listed age limits: 18 years to 65 years. Other eligibility criteria applied.

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