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

NCT03771664 | Terminated Phase 3 Results FDA Drug

• 1 other identifier: 217-MDD-304
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 28

Brief Summary

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.

Conditions

Major Depressive Disorder; Insomnia

Outcome Measures

Primary Outcomes (1)

• Average Change From Baseline in Sleep Efficiency (SE) as Assessed by Polysomnogram (PSG) at Days 13 and 14

  Sleep Efficiency (SE) is the percentage of time in bed spent asleep, determined during an 8-hour overnight PSG recording. The PSG measures the physiological process of sleep by monitoring body functions including brain waves, eye movements, muscle activity or skeletal muscle activation, heart rhythm, blood oxygen saturation, and breathing functions. Stages of sleep include rapid eye movement (REM), non-rapid eye movement (NREM), NREM stage 1 (N1), NREM stage 2 (N2), and NREM stage 3 (N3), scored through evaluation of the electroencephalogram (EEG) signal. The average of 2 nights' PSG measurements at Days 13 and 14 is reported in this outcome measure.

  Baseline and Days 13, 14

Secondary Outcomes (23)

• Change From Baseline in Wake After Sleep Onset (WASO) From Persistent Sleep Onset to Lights-on (Final Wake Time)

  Baseline, Day 14: Overall duration (8 hours) and each 2-hour quarter duration (quarter 1: 0 to 2 hours, quarter 2: 2 to 4 hours, quarter 3: 4 to 6 hours, quarter 4: 6 to 8 hours) of PSG recording

• Change From Baseline in Total Sleep Time (TST)

  Baseline, Day 14: Overall duration (8 hours) and each 2-hour quarter duration (quarter 1: 0 to 2 hours, quarter 2: 2 to 4 hours, quarter 3: 4 to 6 hours, quarter 4: 6 to 8 hours) of PSG recording

• Change From Baseline in Latency to Persistent Sleep (LPS)

  Baseline and Day 14 (EODBT)

• Change From Baseline in Number of Awakenings (NAW)

  Baseline and Day 14 (EODBT)

• Change From Baseline in Mean Duration of Awakenings

  Baseline, Day 14: Overall duration (8 hours) and each 2-hour quarter duration (quarter 1: 0 to 2 hours, quarter 2: 2 to 4 hours, quarter 3: 4 to 6 hours, quarter 4: 6 to 8 hours) of PSG recording

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

SAGE-217

EXPERIMENTAL

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.

Drug: SAGE-217

Interventions

SAGE-217 DRUG

Administered as capsules.

SAGE-217

Placebo DRUG

Administered as capsules.

Placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.
• Participant had an Insomnia Severity Index (ISI) score greater than or equal to (\>=) 15 (moderate to severe insomnia).
• 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.

You may not qualify if:

• Participant had attempted suicide associated within the current episode of MDD.
• 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.
• Participant had a medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder.
• Participant had a medical history of seizures.
• Participant had active psychosis per Investigator assessment.

Sponsors & Collaborators

• Biogen: lead

Study Sites (28)

Sage Investigational Site

Little Rock, Arkansas, 72211, United States

Location

Sage Investigational Site

Rogers, Arkansas, 72758, United States

Location

Sage Investigational Site

Garden Grove, California, 92845, United States

Location

Sage Investigational Site

Oceanside, California, 92056, United States

Location

Sage Investigational Site

San Diego, California, 92103, United States

Location

Sage Investigational Site

Temecula, California, 92591, United States

Location

Sage Investigational Site

Fort Myers, Florida, 33912, United States

Location

Sage Investigational Site

Hollywood, Florida, 33024, United States

Location

Sage Investigational Site

Miami Lakes, Florida, 33016, United States

Location

Sage Investigational Site

North Miami, Florida, 33161, United States

Location

Sage Investigational Site

Atlanta, Georgia, 30331, United States

Location

Sage Investigational Site

Atlanta, Georgia, 30342, United States

Location

Sage Investigational Site

Decatur, Georgia, 30030, United States

Location

Sage Investigational Site

Chicago, Illinois, 60634, United States

Location

Sage Investigational Site

Lake Charles, Louisiana, 70629, United States

Location

Sage Investigational Site

Flowood, Mississippi, 39232, United States

Location

Sage Investigational Site

St Louis, Missouri, 63141, United States

Location

Sage Investigational Site

Las Vegas, Nevada, 89102, United States

Location

Sage Investigational Site

Berlin, New Jersey, 08009, United States

Location

Sage Investigational Site

Albuquerque, New Mexico, 87109, United States

Location

Sage Investigational Site

Brooklyn, New York, 11235, United States

Location

Sage Investigational Site

New York, New York, 10019, United States

Location

Sage Investigational Site

Cincinnati, Ohio, 45212, United States

Location

Sage Investigational Site

Dayton, Ohio, 45417, United States

Location

Sage Investigational Site

Oklahoma City, Oklahoma, 73103, United States

Location

Sage Investigational Site

Salem, Oregon, 97301, United States

Location

Sage Investigational Site

Charleston, South Carolina, 29407, United States

Location

Sage Investigational Site

Austin, Texas, 78754, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Sleep Initiation and Maintenance Disorders

Interventions

zuranolone

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Limitations and Caveats

The study was terminated early due to sponsor's decision and there were no safety concerns.

Results Point of Contact

• Title: US Biogen Clinical Trial Center
• Organization: Biogen

clinicaltrials@biogen.com

866-633-4636

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2018
• First Posted: December 11, 2018
• Study Start: February 4, 2019
• Primary Completion: December 20, 2019
• Study Completion: January 17, 2020
• Last Updated: November 29, 2023
• Results First Posted: October 20, 2022

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share

Locations

US (28)