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

Biogen

Status and phase: Completed; Phase 2

Conditions: Bipolar Disorder I; Major Depressive Episode; Bipolar Disorder II

Treatments: Drug: SAGE-217; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03692910

217-BPD-201

Details and patient eligibility

About

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.

Full description

This study was previously posted by Sage Therapeutics. In November 2023, sponsorship of the trial was transferred to Biogen.

Enrollment: 35 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Participant had a documented history of hypomanic or manic episode and a diagnosis of bipolar I or bipolar II disorder with a current major depressive episode.

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 3 patient groups, including a placebo group

Part A (Open-label): SAGE-217

Experimental group

Description:

Participants self-administered SAGE-217, 30 milligrams (mg), oral capsule, once daily (QD), in the evening, from Day 1 to Day 14.

Treatment:

Drug: SAGE-217

Part B (Double-blind): SAGE-217

Experimental group

Description:

Participants were to receive SAGE-217, 30 mg, oral capsule, QD, in the evening, from Day 1 to Day 14 in Part B of the study. However, as per the Sponsor's decision, the Part B of the study was not conducted.

Treatment:

Drug: SAGE-217

Part B (Double-blind): Placebo

Placebo Comparator group

Description:

Participants were to receive SAGE-217 matching placebo capsule, orally, QD, in the evening, from Day 1 to Day 14 in Part B of the study. However, as per the Sponsor's decision, the Part B of the study was not conducted.

Treatment:

Drug: Placebo