NCT04007367

A Study to Evaluate SAGE-217 for Prevention of Relapse in Adult Participants With Major Depressive Disorder

Terminated Phase 3 Results posted Last updated 29 November 2023

What this trial tests

Phase 3 trial testing SAGE-217 in Major Depressive Disorder in 53 participants. Terminated before completion.

Timeline

6 August 2019

Primary endpoint
6 January 2020

6 January 2020

Quick facts

Lead sponsor	Biogen
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	quadruple
Primary purpose	treatment
Enrollment	53
Start date	6 August 2019
Primary completion	6 January 2020
Estimated completion	6 January 2020
Sites	46 locations across United States

Drugs / interventions tested

• SAGE-217 — full drug profile →
• Placebo

Conditions studied

• Major Depressive Disorder — all drugs for Major Depressive Disorder →

Sponsor

Biogen — full company profile →

Who can join

Adults 18 to 65, any sex, with Major Depressive Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Secondary · From the first dose of study drug up to the end of the study (i.e., up to approximately 22 weeks)

An adverse event (AE) was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. A TEAE was defined as an AE with onset after the start of study drug, or any worsening of a pre-existing medical condition/AE with onset after the start of study drug and throughout the study.

Group	Value	95% CI
Open-Label Phase: SAGE-217	26
Double-Blind Phase: SAGE-217	0

Adverse events — posted to ClinicalTrials.gov

Time frame: From the first dose of study drug up to the end of the study (i.e., up to approximately 22 weeks). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Open-Label Phase: SAGE-217

Serious: 0/53 (0%)

Deaths: 0/53

Double-Blind Phase: Placebo

Serious: 0

Deaths: 0

Double-Blind Phase: SAGE-217

Serious: 0/2 (0%)

Deaths: 0/2

Other adverse events (5 terms — click to expand)

Reaction	System	Open-Label Phase: SAGE-217	Double-Blind Phase: Placebo	Double-Blind Phase: SAGE-217
Headache	Nervous system disorders	—	—	—
Sedation	Nervous system disorders	—	—	—
Somnolence	Nervous system disorders	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—
Dizziness	Nervous system disorders	—	—	—

Data from ClinicalTrials.gov NCT04007367 adverse events section.

Sponsor's own description

This is a study with an Open-Label (OL) phase followed by a randomized, Double-Blind (DB), placebo-controlled phase to assess efficacy and safety of SAGE-217 on relapse prevention in adults with major depressive disorder (MDD).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Clinical specificity profile for novel rapid acting antidepressant drugs.
   Scala M, Fanelli G, De Ronchi D, Serretti A, et al · · 2023 · cited 33× · PMID 37381161 · DOI 10.1097/yic.0000000000000488
2. Emerging Therapeutics Based on the Amino Acid Neurotransmitter System: An Update on the Pharmaceutical Pipeline for Mood Disorders.
   Hecking J, Davoudian PA, Wilkinson ST. · · 2021 · cited 13× · PMID 34124495 · DOI 10.1177/24705470211020446