Double-blind, placebo-controlled test of SPN-821 in adults with major depressive disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomized, double-blind, placebo-controlled Phase 2 trial of adjunctive SPN-821 (2400 mg) given twice weekly versus placebo in adults with major depressive disorder. Eligible participants remain on a stable, approved antidepressant monotherapy and must have a current depressive episode of at least eight weeks with moderate to severe symptoms. The protocol includes a 2-week screening period, a 4-week double-blind treatment period, and a safety follow-up phone call one week after treatment ends. Efficacy and safety will be tracked using standard clinical rating scales (such as MADRS and CGI-S) and routine clinical assessments.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Alabama
  Birmingham, Alabama, United States Recruiting
• IMA Clinical Research Phoenix
  Phoenix, Arizona, United States Recruiting
• Woodland Research Northwest (ERG)
  Rogers, Arkansas, United States Recruiting
• Inland Psychiatric Medical Group
  Chino, California, United States Recruiting
• Leading Edge Research (Eximia Network)
  Encino, California, United States Recruiting
• Cenexel Collaborative Neuroscience Network
  Garden Grove, California, United States Recruiting

Study contacts

• Study coordinator: Gianpiera Ceresoli-Borroni, PhD
• Email: gceresoliborroni@supernus.com
• Phone: 301-838-2521

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.