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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Major Depressive Disorder (MDD)

In brief

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

Key facts

Study ID

NCT07226661

Run by

Supernus Pharmaceuticals, Inc.

People needed

230

Starts

2026-01-19

Expected to finish

2027-01-31

Last updated by the study team

2026-03-24

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Collaborative Neuroscience Network — Garden Grove, California, United States (enrolling)

Full record on ClinicalTrials.gov

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