Progressing TAAR-1, Dopamine, and Norepinephrine in Depression Using Solriamfetol

Completed · Phase 3 · Has a placebo group

Conditions studied: Major Depressive Disorder

In brief

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.

Key facts

Study ID

NCT06360419

Run by

Axsome Therapeutics, Inc.

People needed

346

Starts

2024-03-18

Expected to finish

2025-03-26

Last updated by the study team

2026-01-05

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Clinical Research Site — Little Rock, Arkansas, United States
• Clinical Research Site — Bellflower, California, United States
• Clinical Research Site — Encino, California, United States
• Clinical Research Site — Lemon Grove, California, United States
• Clinical Research Site — Los Angeles, California, United States
• Clinical Research Site — Montclair, California, United States
• Clinical Research Site — Oceanside, California, United States
• Clinical Research Site — Redlands, California, United States
• Clinical Research Site — Riverside, California, United States
• Clinical Research Site — Sherman Oaks, California, United States
• Clinical Research Site — Torrance, California, United States
• Clinical Research Site — Upland, California, United States
• Clinical Research Site — Walnut Creek, California, United States
• Clinical Research Site — Cromwell, Connecticut, United States
• Clinical Research Site — Brandon, Florida, United States
• Clinical Research Site — Hialeah, Florida, United States
• Clinical Research Site — Jacksonville, Florida, 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 — Chicago, Illinois, United States
• Clinical Research Site — Overland Park, Kansas, United States
• Clinical Research Site — New Orleans, Louisiana, United States
• Clinical Research Site — Boston, Massachusetts, United States
• Clinical Research Site — Saint Charles, Missouri, United States

Full record on ClinicalTrials.gov

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