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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
Axsome Therapeutics, Inc.·Phase 3·ClinicalTrials.gov·drugRecruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Major Depressive Disorder
Drug/Device/Intervention
Solriamfetol 300 mg
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Axsome Therapeutics, Inc.
Location
Encino,Lemon Grove,Oceanside,Redlands,Riverside,Sherman Oaks,Upland,Cromwell,Hialeah,Jacksonville,Orlando,Orlando,Orlando,Chicago,Boston,Saint Charles,Las Vegas,Brooklyn,Rochester,Hickory,Oklahoma Cit, United States of America
Timeline & enrollment
Phase
Phase 3
Start date
Mar 18, 2024
End date
Dec 01, 2025
Enrollment
300 participants
Primary outcome

Montgomery-Åsberg Depression Rating Scale (MADRS),Incidence of treatment-emergent adverse events

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.

ICD-10 classifications
Recurrent depressive disorderRecurrent depressive disorder, unspecifiedDepressive conduct disorderOther recurrent depressive disordersRecurrent depressive disorder, current episode moderate
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06360419
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06360419 through Pure Global AI's free database. This Phase 3 trial is sponsored by Axsome Therapeutics, Inc. and is currently Recruiting. The study focuses on Major Depressive Disorder. Target enrollment is 300 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.