NCT07226661

Double-blind, Placebo-controlled Study in Adults With Major Depressive Disorder

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of SPN-821 as an Adjunctive Therapy in Adults With Major Depressive Disorder

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 230 (estimated)
• Sponsor: Supernus Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy and safety of SPN-821 in adults with major depressive disorder

Detailed description

This is a multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of SPN-821 administered twice a week as adjunctive therapy to an approved antidepressant therapy in adult participants with MDD. The study includes a 2-week Screening Period, a 4-week Double blind Treatment Period, and a Safety Follow-up phone call one week after the completion of the Treatment Period.

Conditions

• Major Depressive Disorder (MDD)

Interventions

Type	Name	Description
DRUG	SPN-821 2400 mg	SPN-821 is a novel, orally bioavailable, selective, direct enhancer of mTORC1 cellular signaling
DRUG	Placebo	Matched placebo oral tablets

Timeline

• Start date: 2026-01-19
• Primary completion: 2026-12-31
• Completion: 2027-01-31
• First posted: 2025-11-10
• Last updated: 2026-03-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study