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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 : February 8, 2019
Sponsor:
Information provided by (Responsible Party):
Sage Therapeutics

Tracking Information
First Submitted Date  ICMJE December 14, 2016
First Posted Date  ICMJE December 22, 2016
Last Update Posted Date February 8, 2019
Actual Study Start Date  ICMJE December 7, 2016
Actual Primary Completion Date October 4, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 4, 2019)
  • Safety and tolerability of SAGE-217 as assessed by the frequency and severity of adverse events [Part A] [ Time Frame: 28 Days ]
  • Safety and tolerability of SAGE-217 as assessed by clinical laboratory measures [Part A] [ Time Frame: Between Day 1 and Day 28 ]
  • Safety and tolerability of SAGE-217 as assessed by vital signs [Part A] [ Time Frame: Between Day 1 and Day 28 ]
  • Safety and tolerability of SAGE-217 as assessed by electrocardiograms (ECGs) [Part A] [ Time Frame: Between Day 1 and Day 28 ]
  • 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 ]
  • 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 ]
  • Safety and tolerability of SAGE-217 as assessed by the Stanford Sleepiness Scale (SSS) score [Part A] [ Time Frame: 15 Days ]
  • Safety and tolerability of SAGE-217 as assessed by physical examination [Part A] [ Time Frame: Between Day 1 and Day 28 ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 19, 2016)
  • Safety and tolerability, as assessed by adverse events [Parts A and B] [ Time Frame: 14 days ]
  • Safety and tolerability, as assessed by clinical laboratory measures [Parts A and B] [ Time Frame: 14 days ]
  • Safety and tolerability, as assessed by vital signs [Parts A and B] [ Time Frame: 14 days ]
  • Safety and tolerability, as assessed by electrocardiograms (ECGs) [Parts A and B] [ Time Frame: 14 days ]
  • Safety and tolerability, as assessed by suicidal ideation using the Columbia-Suicide Severity Rating Scale (C-SSRS) [Parts A and B] [ Time Frame: 14 days ]
Change History Complete list of historical versions of study NCT03000530 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 4, 2019)
  • 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 ]
  • 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 ]
  • Safety and tolerability of SAGE-217 as assessed by clinical laboratory measures [Part B] [ Time Frame: 14 days ]
  • Safety and tolerability of SAGE-217 as assessed by vital signs [Part B] [ Time Frame: 14 days ]
  • Safety and tolerability of SAGE-217 as assessed by electrocardiograms (ECGs) [Part B] [ Time Frame: 14 days ]
  • 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 ]
  • Reduction in depressive symptoms as assessed by HAM-D response [Part A] [ Time Frame: Between Day 1 and Day 28 ]
  • Reduction in depressive symptoms as assessed by HAM-D remission [Part A] [ Time Frame: Between Day 1 and Day 28 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Reduction in depressive symptoms as assessed by Clinical Global Impression-Improvement (CGI-I) response [Part A] [ Time Frame: Between Day 1 and Day 28 ]
  • Safety and tolerability of SAGE-217 as assessed by the Stanford Sleepiness Scale (SSS) score [Part B] [ Time Frame: 15 Days ]
  • Safety and tolerability of SAGE-217 as assessed by physical examination [Part B] [ Time Frame: Between Day 1 and Day 42 ]
  • 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 ]
  • Reduction in depressive symptoms, compared to placebo, as assessed by HAM-D response [Part B] [ Time Frame: Between Day 1 and Day 42 ]
  • Reduction in depressive symptoms, compared to placebo, as assessed by HAM-D remission [Part B] [ Time Frame: Between Day 1 and Day 42 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Reduction in depressive symptoms, compared to placebo, as assessed by CGI-I response [Part B] [ Time Frame: Between Day 2 and Day 42 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 19, 2016)
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 [Parts A and B] [ Time Frame: 14 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 Moderate to Severe Major Depressive Disorder
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Major Depression
Intervention  ICMJE
  • Drug: SAGE-217
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: SAGE-217 dosing
    SAGE-217
    Intervention: Drug: SAGE-217
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Publications * Gunduz-Bruce H, Silber C, Kaul I, Rothschild AJ, Riesenberg R, Sankoh AJ, Li H, Lasser R, Zorumski CF, Rubinow DR, Paul SM, Jonas J, Doherty JJ, Kanes SJ. Trial of SAGE-217 in Patients with Major Depressive Disorder. N Engl J Med. 2019 Sep 5;381(10):903-911. doi: 10.1056/NEJMoa1815981.

*   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: November 30, 2017)
102
Original Estimated Enrollment  ICMJE
 (submitted: December 19, 2016)
62
Actual Study Completion Date  ICMJE October 31, 2017
Actual Primary Completion Date October 4, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
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 NCT03000530
Other Study ID Numbers  ICMJE 217-MDD-201
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sage Therapeutics
Study Sponsor  ICMJE Sage Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Christopher Silber, MD Sage Therapeutics
PRS Account Sage Therapeutics
Verification Date February 2019

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