Double-blind, Placebo-controlled Study in Adults With Major Depressive Disorder
Purpose
This study will evaluate the efficacy and safety of SPN-821 in adults with major depressive disorder
Condition
- Major Depressive Disorder (MDD)
Eligibility
- Eligible Ages
- Between 18 Years and 70 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental SPN-821 2400 mg |
Three 800 mg oral tablets administered twice a week adjunctive to current antidepressant |
|
|
Placebo Comparator Placebo |
Three oral tablets administered twice a week adjunctive to current antidepressant |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Supernus Pharmaceuticals, Inc.
Detailed Description
This is a multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of SPN-821 administered twice a week as adjunctive therapy to an approved antidepressant therapy in adult participants with MDD. The study includes a 2-week Screening Period, a 4-week Double blind Treatment Period, and a Safety Follow-up phone call one week after the completion of the Treatment Period.
