Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: NCT03000530
Recruitment Status : Completed
First Posted : December 22, 2016
Last Update Posted : February 8, 2019
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.


Layout table for study information
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
Actual Study Start Date : December 7, 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 of SAGE-217 as assessed by the frequency and severity of adverse events [Part A] [ Time Frame: 28 Days ]
  2. Safety and tolerability of SAGE-217 as assessed by clinical laboratory measures [Part A] [ Time Frame: Between Day 1 and Day 28 ]
  3. Safety and tolerability of SAGE-217 as assessed by vital signs [Part A] [ Time Frame: Between Day 1 and Day 28 ]
  4. Safety and tolerability of SAGE-217 as assessed by electrocardiograms (ECGs) [Part A] [ Time Frame: Between Day 1 and Day 28 ]
  5. Safety and tolerability of SAGE-217 as assessed by suicidal ideation using the Columbia-Suicide Severity Rating Scale (C-SSRS) [Part A] [ Time Frame: Between Day 1 and Day 28 ]
  6. Reduction in depressive symptoms, compared to placebo, as assessed by the change in the 17-item Hamilton Rating Scale for Depression (HAM-D) total score from baseline to Day 15 [Part B] [ Time Frame: 15 Days ]
  7. Safety and tolerability of SAGE-217 as assessed by the Stanford Sleepiness Scale (SSS) score [Part A] [ Time Frame: 15 Days ]
  8. Safety and tolerability of SAGE-217 as assessed by physical examination [Part A] [ Time Frame: Between Day 1 and Day 28 ]

Secondary Outcome Measures :
  1. Reduction in depressive symptoms as assessed by the change from baseline in HAM-D total score at Day 15 and all other time points [Part A] [ Time Frame: Between Day 1 and Day 28 ]
  2. Safety and tolerability of SAGE-217 as assessed by the frequency and severity of adverse events [Part B] [ Time Frame: Between Day 1 and Day 42 ]
  3. Safety and tolerability of SAGE-217 as assessed by clinical laboratory measures [Part B] [ Time Frame: 14 days ]
  4. Safety and tolerability of SAGE-217 as assessed by vital signs [Part B] [ Time Frame: 14 days ]
  5. Safety and tolerability of SAGE-217 as assessed by electrocardiograms (ECGs) [Part B] [ Time Frame: 14 days ]
  6. Safety and tolerability of SAGE-217 as assessed by suicidal ideation using the Columbia-Suicide Severity Rating Scale (C-SSRS) [Part B] [ Time Frame: 14 days ]
  7. Reduction in depressive symptoms as assessed by HAM-D response [Part A] [ Time Frame: Between Day 1 and Day 28 ]
  8. Reduction in depressive symptoms as assessed by HAM-D remission [Part A] [ Time Frame: Between Day 1 and Day 28 ]
  9. Reduction in depressive symptoms as assessed by change from baseline in the Montgomery and Asberg Depression Rating Scale (MADRS) total score at Day 15 and all other time points [Part A] [ Time Frame: Between Day 1 and Day 28 ]
  10. Reduction in depressive symptoms as assessed by change from baseline in HAM-D subscale and individual item scores at Day 15 and all other time points [Part A] [ Time Frame: Between Day 1 and Day 28 ]
  11. Reduction in depressive symptoms as assessed by change from baseline in Hamilton Anxiety Rating Scale (HAM-A) total score at all time points [Part A] [ Time Frame: Between Day 1 and Day 28 ]
  12. Reduction in depressive symptoms as assessed by Clinical Global Impression-Improvement (CGI-I) response [Part A] [ Time Frame: Between Day 1 and Day 28 ]
  13. Safety and tolerability of SAGE-217 as assessed by the Stanford Sleepiness Scale (SSS) score [Part B] [ Time Frame: 15 Days ]
  14. Safety and tolerability of SAGE-217 as assessed by physical examination [Part B] [ Time Frame: Between Day 1 and Day 42 ]
  15. Reduction in depressive symptoms, compared to placebo, as assessed by the change in the 17-item HAM-D total score from baseline at all time points [Part B] [ Time Frame: Between Day 1 and Day 42 ]
  16. Reduction in depressive symptoms, compared to placebo, as assessed by HAM-D response [Part B] [ Time Frame: Between Day 1 and Day 42 ]
  17. Reduction in depressive symptoms, compared to placebo, as assessed by HAM-D remission [Part B] [ Time Frame: Between Day 1 and Day 42 ]
  18. Reduction in depressive symptoms, compared to placebo, as assessed by the change from baseline in the MADRS total score at Day 15 and all other time points [Part B] [ Time Frame: Between Day 1 and Day 42 ]
  19. Reduction in depressive symptoms, compared to placebo, as assessed by the change from baseline in HAM-D subscale and individual item scores at all time points [Part B] [ Time Frame: Between Day 1 and Day 42 ]
  20. Reduction in depressive symptoms, compared to placebo, as assessed by the change from baseline in HAM-A total score at Day 15 and all other time points [Part B] [ Time Frame: Between Day 1 and Day 42 ]
  21. Reduction in depressive symptoms, compared to placebo, as assessed by CGI-I response [Part B] [ Time Frame: Between Day 2 and Day 42 ]


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:

  • 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
Layout table for location information
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
Layout table for investigator information
Study Director: Christopher Silber, MD Sage Therapeutics

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal 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: February 8, 2019
Last Verified: February 2019
Keywords provided by Sage Therapeutics:
Depression
Additional relevant MeSH terms:
Layout table for MeSH terms
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders