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A Study to Evaluate the Safety, Tolerability, and Efficacy of SAGE-217 Compared to Placebo in Adult Participants With Comorbid Major Depressive Disorder (MDD) and Insomnia

NCT ID: NCT03771664

Last Updated: 2023-11-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-04

Study Completion Date

2020-01-17

Brief Summary

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This study is a randomized, double-blind, placebo-controlled study of the safety, tolerability, and efficacy of SAGE-217 compared to placebo in adult participants with comorbid major depressive disorder (MDD) and insomnia.

Detailed Description

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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 Depressive Disorder Insomnia

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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Placebo

Participants received SAGE-217 matching placebo capsules (single-blind), orally, once daily prior to Day 1 (Days -2 and -1) followed by self-administration of SAGE-217 matching placebo capsules, orally, once daily for 12 days. Thereafter participants received SAGE-217 matching placebo capsules, orally, once daily, 30 minutes prior to lights out \[polysomnography (PSG)\] on Days 13 and 14 (double-blind). Thereafter participants self-administered SAGE-217 matching placebo capsules (single-blind), orally, once daily on Days 15 to 21.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered as capsules.

SAGE-217

Participants received SAGE-217 matching placebo capsules (single-blind), orally, once daily prior to Day 1 (Days -2 and -1) followed by self-administration of SAGE-217, 30 milligrams (mg) capsules, orally, once daily for 12 days. Thereafter participants received SAGE-217, 30 mg capsules, orally, once daily, 30 minutes prior to lights out (PSG) on Days 13 and 14 (double-blind). Thereafter participants self-administered SAGE-217 matching placebo capsules (single-blind), orally, once daily on Days 15 to 21.

Group Type EXPERIMENTAL

SAGE-217

Intervention Type DRUG

Administered as capsules.

Interventions

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SAGE-217

Administered as capsules.

Intervention Type DRUG

Placebo

Administered as capsules.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Participant had a diagnosis of MDD as diagnosed by structured clinical interview for diagnostic and statistical manual of mental disorders, fifth edition, clinical trials version (SCID-5-CT), with symptoms that have been present for at least a 4-week period.
2. Participant had a diagnosis of Insomnia that is confirmed at screening based on the diagnostic and statistical manual of mental disorders, fifth edition (DSM-5) diagnostic criteria using the SCID-5-CT.
3. Participant had an Insomnia Severity Index (ISI) score greater than or equal to (\>=) 15 (moderate to severe insomnia).
4. Participant had a Montgomery-Åsberg Depression Rating Scale (MADRS) score of ≥28 prior to dosing and a Hamilton Rating Scale for Depression (HAM-D) total score of ≥20.

Exclusion Criteria

1. Participant had attempted suicide associated within the current episode of MDD.
2. Participant had onset of the current depressive episode during pregnancy or 4 weeks postpartum, or the participant had presented for screening during the 6-month postpartum period.
3. Participant had a medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder.
4. Participant had a medical history of seizures.
5. Participant had active psychosis per Investigator assessment.
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 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

Little Rock, Arkansas, United States

Site Status

Sage Investigational Site

Rogers, Arkansas, United States

Site Status

Sage Investigational Site

Garden Grove, California, United States

Site Status

Sage Investigational Site

Oceanside, California, United States

Site Status

Sage Investigational Site

San Diego, California, United States

Site Status

Sage Investigational Site

Temecula, California, United States

Site Status

Sage Investigational Site

Fort Myers, Florida, United States

Site Status

Sage Investigational Site

Hollywood, Florida, United States

Site Status

Sage Investigational Site

Miami Lakes, Florida, United States

Site Status

Sage Investigational Site

North Miami, Florida, United States

Site Status

Sage Investigational Site

Atlanta, Georgia, United States

Site Status

Sage Investigational Site

Atlanta, Georgia, United States

Site Status

Sage Investigational Site

Decatur, Georgia, United States

Site Status

Sage Investigational Site

Chicago, Illinois, United States

Site Status

Sage Investigational Site

Lake Charles, Louisiana, United States

Site Status

Sage Investigational Site

Flowood, Mississippi, United States

Site Status

Sage Investigational Site

St Louis, Missouri, United States

Site Status

Sage Investigational Site

Las Vegas, Nevada, United States

Site Status

Sage Investigational Site

Berlin, New Jersey, United States

Site Status

Sage Investigational Site

Albuquerque, New Mexico, United States

Site Status

Sage Investigational Site

Brooklyn, New York, United States

Site Status

Sage Investigational Site

New York, New York, United States

Site Status

Sage Investigational Site

Cincinnati, Ohio, United States

Site Status

Sage Investigational Site

Dayton, Ohio, United States

Site Status

Sage Investigational Site

Oklahoma City, Oklahoma, United States

Site Status

Sage Investigational Site

Salem, Oregon, United States

Site Status

Sage Investigational Site

Charleston, South Carolina, United States

Site Status

Sage Investigational Site

Austin, Texas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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217-MDD-304

Identifier Type: -

Identifier Source: org_study_id