Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

RECRUITING

NCT07226661

PHASE2

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

Sponsor: Supernus Pharmaceuticals, Inc.

View on ClinicalTrials.gov

Summary

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

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

230

Start Date

2026-01-19

Completion Date

2027-01-31

Last Updated

2026-10-28

Healthy Volunteers

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

Inclusion Criteria: * Current diagnosis of MDD according to the DSM-5 for either single or recurrent MDE without psychotic features confirmed by the MINI * Duration of current MDE of at least 8 weeks * MADRS total score of ≥ 24 at the Screening Visit and Day 1 Visit * CGI-S score of ≥ 4 (moderately ill or worse) at the Screening Visit and Day 1 Visit * Stable, therapeutic dose of one of the following protocol-approved ADTs as a monotherapy for ≥ 8 weeks before the Screening Visit and ≥ 10 weeks at the Day 1 Visit. Additionally, inadequate response to the current ADT (less than 50% improvement in depressive symptoms) as confirmed by the ATRQ Investigator administered. Exclusion Criteria: * MADRS total score change of ≥ 25% from the Screening Visit to Day 1 Visit * History of treatment resistant depression (TRD) defined as 3 or more failed ADTs of adequate dose (per ATRQ) and duration (at least 8 weeks) for the current MDE * History of alcohol or substance use disorder according to DSM-5 criteria 6 months before the Screening Visit * Evidence of significant risk for suicidal behavior during participation in the study in the Investigator's opinion * Lifetime diagnosis of any psychotic disorder including MDD with psychosis, MDD with mixed features, bipolar I/II disorder, bipolar depression, schizophrenia, posttraumatic stress disorder, autism spectrum disorder, or any personality disorder or intellectual disability that would affect the ability of the participant to enroll in the study * Diagnosis less then 12 months before screening of severe obsessive-compulsive disorder, acute stress disorder, panic disorder, eating disorders, or any other psychiatric condition that has been the primary focus of treatment, or diagnosis of generalized anxiety disorder less then 6 months before screening. * History of cardiovascular, respiratory, gastrointestinal, renal, hepatic, and hematologic disorders, or other medical disorders that could impose undue risk or compromise the study in the Investigator's opinion * Clinically significant abnormal result prior to Day 1 Visit per Investigator's judgment or abnormal renal function. * Requires treatment with a medication or other substance that is prohibited by the protocol.

Locations (40)

University of Alabama

Birmingham, Alabama, United States

IMA Clinical Research Phoenix

Phoenix, Arizona, United States

Woodland Research Northwest (ERG)

Rogers, Arkansas, United States

Inland Psychiatric Medical Group

Chino, California, United States

Leading Edge Research (Eximia Network)

Encino, California, United States

Cenexel Collaborative Neuroscience Network

Garden Grove, California, United States

Synergy Research (ERG Network)

Lemon Grove, California, United States

Catalina Research Institute (Elixia)

Montclair, California, United States

ATP Clinical Research

Orange, California, United States

NRC Research Institute

Orange, California, United States

Lumos Clinical Research Center

San Jose, California, United States

Inland Psychiatric Medical Group

Temecula, California, United States

Mountain View Clinical Research

Denver, Colorado, United States

CT Clinical Research

Cromwell, Connecticut, United States

CNS Healthcare - Jacksonville

Jacksonville, Florida, United States

Avantis Clinical Research

Miami, Florida, United States

CNS Healthcare of Orlando

Orlando, Florida, United States

Space Coast Neuropsychiatric Research Institute

Palm Bay, Florida, United States

Cenexel Tampa

Tampa, Florida, United States

Interventional Psychiatry of Tampa Bay

Tampa, Florida, United States

Cenexel Atlanta (ACMR)

Atlanta, Georgia, United States

Cenexel iResearch Atlanta

Decatur, Georgia, United States

AMR Conventions Research

Warrenville, Illinois, United States

Precise Clinical Research

Flowood, Mississippi, United States

Psychiatric Care and Research Center

O'Fallon, Missouri, United States

Midwest Research Group

Saint Charles, Missouri, United States

Vector Clinical Trials

Las Vegas, Nevada, United States

Cenexel Marlton (HRI)

Marlton, New Jersey, United States

SPRI Clinical Trials

Brooklyn, New York, United States

Manhattan Behavioral Medicine

New York, New York, United States

New Hope Clinical Research

Charlotte, North Carolina, United States

Paradigm Research Professionals

Oklahoma City, Oklahoma, United States

Summit Headlands (Headlands Research)

Portland, Oregon, United States

Houston Clinical Trials

Bellaire, Texas, United States

Baylor College of Medicine

Houston, Texas, United States

DM Clinical

Houston, Texas, United States

Grayline Research Center

Wichita Falls, Texas, United States

Alpine Research Organization

Clinton, Utah, United States

Aura Wellness

Salt Lake City, Utah, United States

Core Clinical Research

Everett, Washington, United States