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A Study to Evaluate the Efficacy of SAGE-217 in the Treatment of Adult Subjects With Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT03672175
Recruitment Status : Recruiting
First Posted : September 14, 2018
Last Update Posted : April 9, 2019
Sponsor:
Information provided by (Responsible Party):
Sage Therapeutics

Brief Summary:
This study is a phase 3, multicenter, double-blind, randomized, placebo-controlled study evaluating the efficacy of SAGE-217 in the treatment of adult subjects with major depressive disorder

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: SAGE-217 Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy of SAGE-217 in the Treatment of Adult Subjects With Major Depressive Disorder
Actual Study Start Date : December 7, 2018
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SAGE-217 (low dose) Drug: SAGE-217
Sage-217

Experimental: SAGE-217 (high dose) Drug: SAGE-217
Sage-217

Placebo Comparator: Placebo Drug: Placebo
Placebo




Primary Outcome Measures :
  1. Change from baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D) total score. [ Time Frame: 15 Days ]

Secondary Outcome Measures :
  1. Change from baseline in the 17-item HAM-D total score at other timepoints. [ Time Frame: Up to 182 Days ]
  2. Change from baseline in the Clinical Global Impression - Improvement (CGI-I) response, defined as "much improved" or "very much improved". [ Time Frame: Up to 182 Days ]
  3. Change from baseline in Clinical Global Impression - Severity (CGI-S) score. [ Time Frame: Up to 182 Days ]
  4. Change from baseline in Hamilton Anxiety Rating Scale (HAM-A) total score. [ Time Frame: 42 Days ]
  5. Change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS). [ Time Frame: 42 Days ]
  6. Incidence and severity of adverse events/serious adverse events. [ Time Frame: Up to 182 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:

1. Subject has a diagnosis of MDD with symptoms that have been present for at least a 4-week period.

Exclusion Criteria:

  1. Subject has active psychosis.
  2. Subject has attempted suicide associated with the current episode of MDD.
  3. Subject has a 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): NCT03672175


Contacts
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Contact: Handan Gunduz-Bruce, MD, MBA 617-949-2883 handan.gunduz-bruce@sagerx.com

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Sponsors and Collaborators
Sage Therapeutics

Additional Information:
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Responsible Party: Sage Therapeutics
ClinicalTrials.gov Identifier: NCT03672175     History of Changes
Other Study ID Numbers: 217-MDD-301
First Posted: September 14, 2018    Key Record Dates
Last Update Posted: April 9, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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