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Progressing TAAR-1, Dopamine, and Norepinephrine in Depression Using Solriamfetol - Trial NCT06360419

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.

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NCT06360419
Phase 3
Recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06360419
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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

Study Focus

Major Depressive Disorder

Solriamfetol 300 mg

Interventional

drug

Sponsor & Location

Axsome Therapeutics, Inc.

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 3

Mar 18, 2024

Dec 01, 2025

300 participants

Primary Outcome

Montgomery-ร…sberg 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 disorder
Recurrent depressive disorder, unspecified
Depressive conduct disorder
Other recurrent depressive disorders
Recurrent depressive disorder, current episode moderate

Data Source

ClinicalTrials.gov

NCT06360419

Non-Device Trial