NCT06360419CompletedPhase 3
Progressing TAAR-1, Dopamine, and Norepinephrine in Depression Using Solriamfetol
A Randomized, Double-Blind, Placebo-Controlled Trial of Solriamfetol in Subjects With Major Depressive Disorder
Source: ClinicalTrials.gov · Last updated 5 Jan 2026
Brief summary (registry, in English)
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 (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 346 (actual)
- First submitted
- 8 Apr 2024
- Start date
- 18 Mar 2024
- Primary completion date
- 31 Dec 2024
- Lead sponsor
- Axsome Therapeutics, Inc.
- Diseases
- Depression
- NCT number
- NCT06360419
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 346
- From 18 Mar 2024 to the primary completion date, 31 Dec 2024
- 38 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior exposure to solriamfetol/Sunosi, through either a clinical study or prescription
Other
- Unable to comply with study procedures
- Medically inappropriate for study participation in the opinion of the investigator
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (38)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinical Research Site Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | Bellflower | United States | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | Brandon | United States | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | Brooklyn | United States | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | Cromwell | United States | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | Encino | United States | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | Everett | United States | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | Friendswood | United States | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | Hialeah | United States | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | Hickory | United States | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | Lemon Grove | United States | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | Little Rock | United States | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | Media | United States | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | Memphis | United States | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | Montclair | United States | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | New Orleans | United States | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | Oceanside | United States | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | Oklahoma City | United States | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | Overland Park | United States | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | Redlands | United States | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | Riverside | United States | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | Saint Charles | United States | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | Sherman Oaks | United States | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | Staten Island | United States | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | Torrance | United States | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | Upland | United States | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | Walnut Creek | United States | Unknown status |
| Clinical Research Site Coordinator of this site? Confirm its status | Wichita Falls | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.