RecruitingPhase 2NCT07226661

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

Sponsor

Supernus Pharmaceuticals, Inc.

Enrollment

230 participants

Start Date

Jan 19, 2026

Study Type

INTERVENTIONAL

Conditions

Major Depressive Disorder (MDD)

Summary

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

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Placebo and a drug called SPN-821 2400 mg for people with major depressive disorder (mdd). The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 70 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSPN-821 2400 mg

SPN-821 is a novel, orally bioavailable, selective, direct enhancer of mTORC1 cellular signaling

DRUGPlacebo

Matched placebo oral tablets

Locations(1)

Collaborative Neuroscience Network

Garden Grove, California, United States

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NCT07226661

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