Actively Recruiting
Double-blind, Placebo-controlled Study in Adults With Major Depressive Disorder
Led by Supernus Pharmaceuticals, Inc. · Updated on 2026-03-24
230
Participants Needed
1
Research Sites
53 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study will evaluate the efficacy and safety of SPN-821 in adults with major depressive disorder
CONDITIONS
Official Title
Double-blind, Placebo-controlled Study in Adults With Major Depressive Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Current diagnosis of major depressive disorder (MDD) according to DSM-5 for single or recurrent episodes without psychotic features confirmed by MINI
- Duration of current major depressive episode (MDE) of at least 8 weeks
- Montgomery-Åsberg Depression Rating Scale (MADRS) total score of 24 or higher at Screening and Day 1 visits
- Clinical Global Impression-Severity (CGI-S) score of 4 or higher (moderately ill or worse) at Screening and Day 1 visits
- Stable therapeutic dose of one approved antidepressant therapy (ADT) as monotherapy for at least 8 weeks before Screening and at least 10 weeks by Day 1 visit
- Inadequate response to current ADT (less than 50% improvement in depressive symptoms) confirmed by ATRQ Investigator assessment
You will not qualify if you...
- MADRS total score change of 25% or more between Screening and Day 1 visits
- History of treatment resistant depression (TRD) defined as 3 or more failed antidepressant therapies of adequate dose and duration for current MDE
- History of alcohol or substance use disorder within 6 months before Screening
- Significant risk for suicidal behavior in the Investigator's opinion
- Lifetime diagnosis of psychotic disorders, bipolar disorders, schizophrenia, PTSD, autism spectrum disorder, personality disorder, or intellectual disability affecting study participation
- Diagnosis less than 12 months before Screening of severe obsessive-compulsive disorder, acute stress disorder, panic disorder, eating disorders, or any other primary psychiatric treatment focus
- Diagnosis of generalized anxiety disorder less than 6 months before Screening
- History of cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical disorders posing undue risk or compromising study participation
- Clinically significant abnormal test results or abnormal renal function before Day 1 visit
- Need for treatment with prohibited medications or substances during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Collaborative Neuroscience Network
Garden Grove, California, United States, 92845
Actively Recruiting
Research Team
G
Gianpiera Ceresoli-Borroni, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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