Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03692910
Recruitment Status : Completed
First Posted : October 2, 2018
Last Update Posted : May 1, 2019
Sponsor:
Information provided by (Responsible Party):
Sage Therapeutics

Tracking Information
First Submitted Date  ICMJE September 12, 2018
First Posted Date  ICMJE October 2, 2018
Last Update Posted Date May 1, 2019
Actual Study Start Date  ICMJE August 19, 2018
Actual Primary Completion Date March 23, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 29, 2019)
  • The safety and tolerability of SAGE-217 as assessed by the frequency and severity of adverse events. [ Time Frame: 42 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: 42 Days ]
  • The safety and tolerability of SAGE-217 as assessed by mania using the Young Mania Rating Scale (YMRS). [ Time Frame: 42 Days ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 1, 2018)
  • 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 ]
Change History Complete list of historical versions of study NCT03692910 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 29, 2019)
  • Change from baseline in the 17-item HAM-D total score. [ Time Frame: 15 Days ]
  • Change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score. [ Time Frame: 15 Days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 1, 2018)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Bipolar Disorder I
  • Bipolar Disorder II
  • Major Depressive Episode
Intervention  ICMJE Drug: SAGE-217
SAGE-217
Study Arms  ICMJE Experimental: SAGE-217
Intervention: Drug: SAGE-217
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 29, 2019)
35
Original Estimated Enrollment  ICMJE
 (submitted: October 1, 2018)
30
Actual Study Completion Date  ICMJE March 23, 2019
Actual Primary Completion Date March 23, 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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03692910
Other Study ID Numbers  ICMJE 217-BPD-201
Has Data Monitoring Committee No
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  ICMJE Not Provided
Responsible Party Sage Therapeutics
Study Sponsor  ICMJE Sage Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Sage Therapeutics
Verification Date April 2019

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