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

NCT07226661 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 230

Last updated 2026-03-24

No results posted yet for this study

Summary

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

Conditions

  • Major Depressive Disorder (MDD)

Interventions

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

Sponsors & Collaborators

  • Supernus Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-19
Primary Completion
2026-12-31
Completion
2027-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07226661 on ClinicalTrials.gov