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

NCT ID: NCT03692910

Last Updated: 2023-12-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-23

Study Completion Date

2019-05-21

Brief Summary

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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.

Detailed Description

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

Conditions

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Bipolar Disorder I Bipolar Disorder II Major Depressive Episode

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part A (Open-label): SAGE-217

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

Group Type EXPERIMENTAL

SAGE-217

Intervention Type DRUG

SAGE-217 capsule

Part B (Double-blind): SAGE-217

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.

Group Type EXPERIMENTAL

SAGE-217

Intervention Type DRUG

SAGE-217 capsule

Part B (Double-blind): Placebo

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

SAGE-217 matching placebo capsule

Interventions

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SAGE-217

SAGE-217 capsule

Intervention Type DRUG

Placebo

SAGE-217 matching placebo capsule

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biogen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sage Investigational Site

Little Rock, Arkansas, United States

Site Status

Sage Investigational Site

Garden Grove, California, United States

Site Status

Sage Investigational Site

Lemon Grove, California, United States

Site Status

Sage Investigational Site

Orange, California, United States

Site Status

Sage Investigational Site

Jacksonville, Florida, United States

Site Status

Sage Investigational Site

Lauderhill, Florida, United States

Site Status

Sage Investigational Site

Orlando, Florida, United States

Site Status

Sage Investigational Site

Decatur, Georgia, United States

Site Status

Sage Investigational Site

St Louis, Missouri, United States

Site Status

Sage Investigational Site

Austin, Texas, United States

Site Status

Sage Investigational Site

Richardson, Texas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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http://www.sagerx.com

Related Info

Other Identifiers

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217-BPD-201

Identifier Type: -

Identifier Source: org_study_id