NCT06360419

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 346 (actual)
• Sponsor: Axsome Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	Solriamfetol 300 mg	Solriamfetol tablets, taken once daily
DRUG	Placebo	Placebo tablets, taken once daily

Timeline

• Start date: 2024-03-18
• Primary completion: 2024-12-31
• Completion: 2025-03-26
• First posted: 2024-04-11
• Last updated: 2026-01-05

Locations

40 sites across 1 country: United States

Regulatory

• FDA-regulated drug study