Tests SPN-821 added to treatment for adults with major depressive disorder

Trial details

Who runs it

Supernus Pharmaceuticals, Inc.

Trial code

NCT07226661

Record updated

28 October 2026

Original description

This study will evaluate the efficacy and safety of SPN-821 in adults with major depressive disorderRead full original descriptionShow less

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

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

Inclusion: 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: History of alcohol or substance use disorder according to DSM-5 criteria 6 months before the Screening Visit; 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; 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; 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; 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; 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; MADRS total score change of ≥ 25% from the Screening Visit to Day 1 Visit; Evidence of significant risk for suicidal behavior during participation in the study in the Investigator's opinion.

ClinicalTrials.gov NCT07226661