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Completed Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT06360419

Public ClinicalTrials.gov record NCT06360419. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 30, 2026, 8:43 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized, Double-Blind, Placebo-Controlled Trial of Solriamfetol in Subjects With Major Depressive Disorder

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT06360419
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Axsome Therapeutics, Inc.
Industry
Enrollment
346 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 65 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 18, 2024 (Actual)
Primary completion
Dec 31, 2024 (Actual)
Completion
Mar 26, 2025 (Actual)
Last update posted
Jan 5, 2026

2024 – 2025

United States locations

U.S. sites
40
U.S. states
18
U.S. cities
38
Facility City State ZIP Site status
Clinical Research Site Little Rock Arkansas 72211 —
Clinical Research Site Bellflower California 90706 —
Clinical Research Site Encino California 91316 —
Clinical Research Site Lemon Grove California 91945 —
Clinical Research Site Los Angeles California 90015 —
Clinical Research Site Montclair California 91763 —
Clinical Research Site Oceanside California 92056 —
Clinical Research Site Redlands California 92374 —
Clinical Research Site Riverside California 92506 —
Clinical Research Site Sherman Oaks California 91403 —
Clinical Research Site Torrance California 90501 —
Clinical Research Site Upland California 91786 —
Clinical Research Site Walnut Creek California 94596 —
Clinical Research Site Cromwell Connecticut 06416 —
Clinical Research Site Brandon Florida 33511 —
Clinical Research Site Hialeah Florida 33012 —
Clinical Research Site Jacksonville Florida 32256 —
Clinical Research Site Orlando Florida 32801 —
Clinical Research Site Orlando Florida 32806 —
Clinical Research Site Orlando Florida 32807 —
Clinical Research Site Chicago Illinois 60634 —
Clinical Research Site Overland Park Kansas 66210 —
Clinical Research Site New Orleans Louisiana 70115 —
Clinical Research Site Boston Massachusetts 02131 —
Clinical Research Site Saint Charles Missouri 63304 —
Clinical Research Site Las Vegas Nevada 89102 —
Clinical Research Site Brooklyn New York 11235 —
Clinical Research Site Rochester New York 14609 —
Clinical Research Site Staten Island New York 10314 —
Clinical Research Site Hickory North Carolina 28601 —
Clinical Research Site Cincinnati Ohio 45215 —
Clinical Research Site Oklahoma City Oklahoma 73116 —
Clinical Research Site Media Pennsylvania 19063 —
Clinical Research Site Philadelphia Pennsylvania 19104 —
Clinical Research Site Memphis Tennessee 38119 —
Clinical Research Site Austin Texas 78737 —
Clinical Research Site Dallas Texas 75231 —
Clinical Research Site Friendswood Texas 77546 —
Clinical Research Site Wichita Falls Texas 76309 —
Clinical Research Site Everett Washington 98201 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06360419, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 5, 2026 · Synced Oct 30, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT06360419 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →