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

NCT ID: NCT03000530

Last Updated: 2023-11-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-07

Study Completion Date

2017-11-08

Brief Summary

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This is a two-part (open-label followed by double-blind) study evaluating the safety, tolerability, pharmacokinetics, and efficacy of SAGE-217 in 102 participants diagnosed with moderate to severe Major Depressive Disorder.

Detailed Description

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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 participants were randomized to SAGE-217 or placebo for 14 days.

This study was previously posted by Sage Therapeutics. In November 2023, sponsorship of the trial was transferred to Biogen.

Conditions

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Major Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Part A: SAGE-217

Participants received SAGE-217, 30 milligrams (mg), oral solution, once daily for 14 days, as tolerated.

Group Type EXPERIMENTAL

SAGE-217

Intervention Type DRUG

Part B: Placebo

Eligible participants received matching placebo capsules once daily for 14 days.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Part B: SAGE-217

Eligible participants received SAGE-217, 30 mg, oral capsules, once daily for 14 days.

Group Type EXPERIMENTAL

SAGE-217

Intervention Type DRUG

Interventions

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SAGE-217

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Participant 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

* Participant has a history of suicide attempt
* Participant 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
* Participant has active psychosis
* Participant has a medical history of seizures
* Participant has a medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biogen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sage Investigational Site

Garden Grove, California, United States

Site Status

Sage Investigational Site

Orlando, Florida, United States

Site Status

Sage Investigational Site

Atlanta, Georgia, United States

Site Status

Sage Investigational Site

Lake Charles, Louisiana, United States

Site Status

Sage Investigational Site

Berlin, New Jersey, United States

Site Status

Sage Investigational Site

Dayton, Ohio, United States

Site Status

Sage Investigational Site

Austin, Texas, United States

Site Status

Sage Investigational Site

Charlottesville, Virginia, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 31483961 (View on PubMed)

Suthoff E, Kosinski M, Arnaud A, Hodgkins P, Gunduz-Bruce H, Lasser R, Silber C, Sankoh AJ, Li H, Werneburg B, Jonas J, Doherty J, Kanes SJ, Bonthapally V. Patient-reported health-related quality of life from a randomized, placebo-controlled phase 2 trial of zuranolone in adults with major depressive disorder. J Affect Disord. 2022 Jul 1;308:19-26. doi: 10.1016/j.jad.2022.03.068. Epub 2022 Apr 2.

Reference Type DERIVED
PMID: 35378149 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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http://www.sagerx.com

Related Info

Other Identifiers

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217-MDD-201

Identifier Type: -

Identifier Source: org_study_id