NCT04476030|CompletedPhase 3ResultsFDA Drug

A Comparative Study of Sage-217 Plus an Antidepressant (ADT) Versus Placebo Plus an ADT in Adults With Major Depressive Disorder

A Phase 3, Randomized, Double-Blind Study Comparing the Efficacy and Safety of SAGE-217 Plus an Antidepressant Versus Placebo Plus an Antidepressant in Adults With Major Depressive Disorder

Biogen ClinicalTrials.gov

Compare

1 other identifier

217-MDD-305

Study Type

interventional

Target

440

Locations

1 country

Sites

Timeline

RegisteredJul 2020

StartedNov 2020

CompletionDec 2021

Brief Summary

The primary purpose of this study is to evaluate the efficacy of SAGE-217 plus an ADT in the treatment of major depressive disorder (MDD) compared to placebo plus an ADT.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

440

participants targeted

Target at P50-P75 for phase_3

Timeline

Completed

Started Nov 2020

Shorter than P25 for phase_3

Geographic Reach

1 country

51 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.1 years study duration

First Submitted

Initial submission to the registry

July 15, 2020

Completed

2 days until next milestone

First Posted

Study publicly available on registry

July 17, 2020

Completed

4 months until next milestone

Study Start

First participant enrolled

November 9, 2020

Completed

12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2021

Completed

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2021

Completed

1.9 years until next milestone

Results Posted

Study results publicly available

November 7, 2023

Completed

Last Updated

December 22, 2023

Status Verified

December 1, 2023

Enrollment Period

12 months

First QC Date

July 15, 2020

Results QC Date

August 25, 2023

Last Update Submit

December 20, 2023

Conditions

Depressive Disorder, Major

Keywords

Major Depressive DisorderMDDSAGE-217

Outcome Measures

Primary Outcomes (1)

Change From Baseline in the HAMD-17 Total Score at Day 3
The 17-item HAM-D scale is used to assess the severity of depression. It is comprised of individual ratings related to following symptoms: depressed mood, feelings of guilt, suicide, insomnia, work and activities, retardation, agitation, anxiety, somatic symptoms, genital symptoms, hypochondriasis, loss of weight, and insight. Individual items are scored on either 3-point (0=none to 2=severe) or 5-point scale (0=none/absent to 4=most severe). Total score is the sum of individual items, ranging from 0 (not depressed) to 52 (severely depressed); where a higher score indicates more depression. A negative change from baseline indicated improvement. Least Squares (LS) mean was estimated using mixed effects model for repeated measures (MMRM) analysis.
Baseline, Day 3

Secondary Outcomes (15)

Change From Baseline in the HAMD-17 Total Score Over the Double-Blind Treatment Period
Baseline through Day 15
Change From Baseline in the HAMD-17 Total Score at Days 15 and 42
Baseline, Days 15 and 42
Change From Baseline in the HAMD-17 Total Score Around End of Blinded Treatment
Baseline, End of blinded treatment assessment (i.e., average of Days 12, 15 , and 18)
Percentage of Participants With HAMD-17 Response at Day 15 and Day 42
At Days 15 and 42
Percentage of Participants With HAMD-17 Remission at Day 15 and Day 42
Days 15 and 42
+10 more secondary outcomes

Study Arms (2)

Placebo + Assigned ADT

ACTIVE COMPARATOR

Participants received SAGE-217-matching placebo capsules, orally, once daily along with an assigned ADT (sertraline, escitalopram, citalopram, duloxetine, or desvenlafaxine administered per labeled prescribing information), daily, from Day 1 through 14, followed by the same ADT, per labeled prescribing information, daily, up to Day 42.

Drug: Matching PlaceboDrug: SertralineDrug: EscitalopramDrug: CitalopramDrug: DuloxetineDrug: Desvenlafaxine

SAGE-217 + Assigned ADT

EXPERIMENTAL

Participants received SAGE-217, 50 milligrams (mg), orally, once daily along with an assigned ADT (sertraline, escitalopram, citalopram, duloxetine, or desvenlafaxine administered per labeled prescribing information), daily from Day 1 through 14, followed by the same ADT, per labeled prescribing information, daily, up to Day 42.

Drug: SAGE-217Drug: SertralineDrug: EscitalopramDrug: CitalopramDrug: DuloxetineDrug: Desvenlafaxine

Interventions

SAGE-217DRUG

Oral capsules

SAGE-217 + Assigned ADT

Matching PlaceboDRUG

Oral capsules

Placebo + Assigned ADT

SertralineDRUG

Oral tablets