Major Depressive Disorder Clinical Trial
— PARADIGMOfficial title:
A Randomized, Double-Blind, Placebo-Controlled Trial of Solriamfetol in Subjects With Major Depressive Disorder
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.
| Status | Recruiting |
| Enrollment | 300 |
| Est. completion date | December 2025 |
| Est. primary completion date | December 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Clinical Research Site | Boston | Massachusetts |
| United States | Clinical Research Site | Brooklyn | New York |
| United States | Clinical Research Site | Chicago | Illinois |
| United States | Clinical Research Site | Cromwell | Connecticut |
| United States | Clinical Research Site | Encino | California |
| United States | Clinical Research Site | Everett | Washington |
| United States | Clinical Research Site | Hialeah | Florida |
| United States | Clinical Research Site | Hickory | North Carolina |
| United States | Clinical Research Site | Jacksonville | Florida |
| United States | Clinical Research Site | Las Vegas | Nevada |
| United States | Clinical Research Site | Lemon Grove | California |
| United States | Clinical Research Site | Media | Pennsylvania |
| United States | Clinical Research Site | Memphis | Tennessee |
| United States | Clinical Research Site | Oceanside | California |
| United States | Clinical Research Site | Oklahoma City | Oklahoma |
| United States | Clinical Research Site | Orlando | Florida |
| United States | Clinical Research Site | Orlando | Florida |
| United States | Clinical Research Site | Orlando | Florida |
| United States | Clinical Research Site | Redlands | California |
| United States | Clinical Research Site | Riverside | California |
| United States | Clinical Research Site | Rochester | New York |
| United States | Clinical Research Site | Saint Charles | Missouri |
| United States | Clinical Research Site | Sherman Oaks | California |
| United States | Clinical Research Site | Upland | California |
| United States | Clinical Research Site | Wichita Falls | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| Axsome Therapeutics, Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Montgomery-Åsberg Depression Rating Scale (MADRS) | 6 weeks | ||
| Primary | Incidence of treatment-emergent adverse events | 6 weeks |
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