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

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.

Condition or disease Intervention/treatment Phase
Bipolar Disorder I Bipolar Disorder II Major Depressive Episode Drug: SAGE-217 Phase 2

Detailed Description:
This posting addresses Part A

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 19, 2018
Actual Primary Completion Date : March 23, 2019
Actual Study Completion Date : March 23, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SAGE-217 Drug: SAGE-217
SAGE-217




Primary Outcome Measures :
  1. The safety and tolerability of SAGE-217 as assessed by the frequency and severity of adverse events. [ Time Frame: 42 Days ]
  2. 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 ]
  3. The safety and tolerability of SAGE-217 as assessed by mania using the Young Mania Rating Scale (YMRS). [ Time Frame: 42 Days ]

Secondary Outcome Measures :
  1. Change from baseline in the 17-item HAM-D total score. [ Time Frame: 15 Days ]
  2. Change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score. [ Time Frame: 15 Days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03692910


Locations
Layout table for location information
United States, Arkansas
Sage Investigational Site
Little Rock, Arkansas, United States, 72211
United States, California
Sage Investigational Site
Garden Grove, California, United States, 92845
Sage Investigational Site
Lemon Grove, California, United States, 91945
Sage Investigational Site
Orange, California, United States, 92868
United States, Florida
Sage Investigational Site
Jacksonville, Florida, United States, 32256
Sage Investigational Site
Lauderhill, Florida, United States, 33319
Sage Investigational Site
Orlando, Florida, United States, 32801
United States, Georgia
Sage Investigational Site
Decatur, Georgia, United States, 30030
United States, Missouri
Sage Investigational Site
Saint Louis, Missouri, United States, 63141
United States, Texas
Sage Investigational Site
Austin, Texas, United States, 78754
Sage Investigational Site
Richardson, Texas, United States, 75080
Sponsors and Collaborators
Sage Therapeutics

Additional Information:
Layout table for additonal information
Responsible Party: Sage Therapeutics
ClinicalTrials.gov Identifier: NCT03692910     History of Changes
Other Study ID Numbers: 217-BPD-201
First Posted: October 2, 2018    Key Record Dates
Last Update Posted: May 1, 2019
Last Verified: April 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Disease
Bipolar Disorder
Depression
Depressive Disorder
Depressive Disorder, Major
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders
Behavioral Symptoms
Mood Disorders