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A Study to Evaluate SAGE-217 in Subjects With Moderate to Severe Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT03000530
Recruitment Status : Completed
First Posted : December 22, 2016
Last Update Posted : October 5, 2018
Sponsor:
Information provided by (Responsible Party):
Sage Therapeutics

Brief Summary:
This is a two-part (open-label followed by double-blind) study evaluating the safety, tolerability, pharmacokinetics, and efficacy of SAGE-217 in approximately 98 subjects diagnosed with moderate to severe Major Depressive Disorder.

Condition or disease Intervention/treatment Phase
Major Depression Drug: SAGE-217 Drug: Placebo Phase 2

Detailed Description:

Part A of the study is an open-label design with dosing of SAGE-217 for 14 days.

Part B of the study is a randomized, double-blind, parallel-group, placebo-controlled design. Eligible subjects will be randomized to SAGE-217 or placebo for 14 days.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Two-Part (Open-Label Followed by Double-Blind) Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of SAGE-217 in the Treatment of Adult Subjects With Moderate to Severe Major Depressive Disorder
Study Start Date : December 2016
Actual Primary Completion Date : October 4, 2017
Actual Study Completion Date : October 31, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SAGE-217 dosing
SAGE-217
Drug: SAGE-217
Placebo Comparator: Placebo
Placebo
Drug: Placebo



Primary Outcome Measures :
  1. Safety and tolerability, as assessed by adverse events [Part A] [ Time Frame: 14 days ]
  2. Safety and tolerability, as assessed by clinical laboratory measures [Part A] [ Time Frame: 14 days ]
  3. Safety and tolerability, as assessed by vital signs [Part A] [ Time Frame: 14 days ]
  4. Safety and tolerability, as assessed by electrocardiograms (ECGs) [Part A] [ Time Frame: 14 days ]
  5. Safety and tolerability, as assessed by suicidal ideation using the Columbia-Suicide Severity Rating Scale (C-SSRS) [Part A] [ Time Frame: 14 days ]
  6. The effect of treatment with SAGE-217 compared to placebo on depressive symptoms in patients with Major Depressive Disorder as assessed by the Hamilton Rating Scale for Depression (HAM-D) total score [Part B] [ Time Frame: 14 days ]

Secondary Outcome Measures :
  1. The effect of treatment with SAGE-217 on depressive symptoms in patients with Major Depressive Disorder as assessed by the Hamilton Rating Scale for Depression (HAM-D) total score [Part A] [ Time Frame: 14 days ]
  2. Safety and tolerability, as assessed by adverse events [Part B] [ Time Frame: 14 days ]
  3. Safety and tolerability, as assessed by clinical laboratory measures [Part B] [ Time Frame: 14 days ]
  4. Safety and tolerability, as assessed by vital signs [Part B] [ Time Frame: 14 days ]
  5. Safety and tolerability, as assessed by electrocardiograms (ECGs) [Part B] [ Time Frame: 14 days ]
  6. Safety and tolerability, as assessed by suicidal ideation using the Columbia-Suicide Severity Rating Scale (C-SSRS) [Part B] [ Time Frame: 14 days ]


Information from the National Library of Medicine

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

Inclusion Criteria:

  • Subject has a diagnosis of Major Depressive Disorder that has been present for at least a 4-week period as diagnosed by Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I)

Exclusion Criteria:

  • Subject has a history of suicide attempt
  • Subject has a history of treatment-resistant depression, defined as persistent depressive symptoms despite treatment with adequate doses of antidepressants from two different classes for an adequate amount of time
  • Active psychosis
  • Medical history of seizures
  • Medical history of bipolar disorder, schizophrenia, and/or schizoaffective 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): NCT03000530


Locations
United States, California
Sage Investigational Site
Garden Grove, California, United States, 92845
United States, Florida
Sage Investigational Site
Orlando, Florida, United States, 32806
United States, Georgia
Sage Investigational Site
Atlanta, Georgia, United States, 30331
United States, Louisiana
Sage Investigational Site
Lake Charles, Louisiana, United States, 70629
United States, New Jersey
Sage Investigational Site
Berlin, New Jersey, United States, 08009
United States, Ohio
Sage Investigational Site
Dayton, Ohio, United States, 45417
United States, Texas
Sage Investigational Site
Austin, Texas, United States, 78754
United States, Virginia
Sage Investigational Site
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
Sage Therapeutics
Investigators
Study Director: Christopher Silber, MD Sage Therapeutics

Additional Information:
Responsible Party: Sage Therapeutics
ClinicalTrials.gov Identifier: NCT03000530     History of Changes
Other Study ID Numbers: 217-MDD-201
First Posted: December 22, 2016    Key Record Dates
Last Update Posted: October 5, 2018
Last Verified: December 2017

Keywords provided by Sage Therapeutics:
Depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders