Progressing TAAR-1, Dopamine, and Norepinephrine in Depression Using Solriamfetol
Purpose
PARADIGM (Progressing TAAR-1, Dopamine, and Norepinephrine in Depression Using Solriamfetol) is a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial to assess the safety and efficacy of solriamfetol for the treatment of major depressive disorder (MDD) in adults.
Condition
- Major Depressive Disorder
Eligibility
- Eligible Ages
- Between 18 Years and 65 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Currently meets the DSM-5 criteria for MDD without psychotic features, based on the SCID-5-CT - Current major depressive episode - Male or female, aged 18 to 65 inclusive
Exclusion Criteria
- Prior exposure to solriamfetol/Sunosi, through either a clinical study or prescription - Unable to comply with study procedures - Medically inappropriate for study participation in the opinion of the investigator
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Solriamfetol 300 mg |
Up to 6 weeks |
|
|
Placebo Comparator Placebo |
Up to 6 weeks |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Axsome Therapeutics, Inc.
Detailed Description
Eligible subjects must have a primary diagnosis of MDD without psychotic features based on the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5) criteria. Subjects will be randomized in a 1:1 ratio to receive either solriamfetol (300 mg) or placebo for 6 weeks.
