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

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

September 12, 2018

First Posted Date ^ICMJE

October 2, 2018

Last Update Posted Date

October 3, 2018

Actual Study Start Date ^ICMJE

August 19, 2018

Estimated Primary Completion Date

July 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The safety and tolerability of SAGE-217 as assessed by the frequency and severity of adverse events.[ Time Frame: 14 Days ]

The safety and tolerability of SAGE-217 as assessed by suicidal ideation and behavior using the Columbia Suicide Severity Rating Scale (C-SSRS).[ Time Frame: 14 Days ]

The safety and tolerability of SAGE-217 as assessed by mania using the Young Mania Rating Scale (YMRS).[ Time Frame: 14 Days ]

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Change from baseline in the 17-item HAM-D total score.[ Time Frame: 42 Days ]
Change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score.[ Time Frame: 42 Days ]

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

This is an open-label study evaluating 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.

Detailed Description

This posting addresses Part A

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation:
Intervention Model: Single Group Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

Drug: SAGE-217
SAGE-217

Study Arms

Experimental: SAGE-217

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

September 2019

Estimated Primary Completion Date

July 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria: 1. Subject has 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. Subject has a history of suicide attempt. 2. Subject has current suicidal ideation with plans. 3. Subject has a history of rapid cycling bipolar disorder.

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

，

Study Sponsor ^ICMJE

Sage Therapeutics

Collaborators ^ICMJE

Investigators ^ICMJE

PRS Account

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

请使用微信扫码报名