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

NCT ID: NCT06360419

Last Updated: 2026-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

346 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-18

Study Completion Date

2025-03-26

Brief Summary

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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

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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

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Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Solriamfetol 300 mg

Up to 6 weeks

Group Type EXPERIMENTAL

Solriamfetol 300 mg

Intervention Type DRUG

Solriamfetol tablets, taken once daily

Placebo

Up to 6 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo tablets, taken once daily

Interventions

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Solriamfetol 300 mg

Solriamfetol tablets, taken once daily

Intervention Type DRUG

Placebo

Placebo tablets, taken once daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Axsome Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clinical Research Site

Little Rock, Arkansas, United States

Site Status

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Bellflower, California, United States

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Encino, California, United States

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Lemon Grove, California, United States

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Los Angeles, California, United States

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Montclair, California, United States

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Oceanside, California, United States

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Redlands, California, United States

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Riverside, California, United States

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Sherman Oaks, California, United States

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Torrance, California, United States

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Upland, California, United States

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Walnut Creek, California, United States

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Cromwell, Connecticut, United States

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Brandon, Florida, United States

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Hialeah, Florida, United States

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Jacksonville, Florida, United States

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Orlando, Florida, United States

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Orlando, Florida, United States

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Orlando, Florida, United States

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Chicago, Illinois, United States

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Overland Park, Kansas, United States

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New Orleans, Louisiana, United States

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Boston, Massachusetts, United States

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Saint Charles, Missouri, United States

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Las Vegas, Nevada, United States

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Brooklyn, New York, United States

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Rochester, New York, United States

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Staten Island, New York, United States

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Hickory, North Carolina, United States

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Cincinnati, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Media, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Memphis, Tennessee, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Friendswood, Texas, United States

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Wichita Falls, Texas, United States

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Everett, Washington, United States

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Countries

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United States

Related Links

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http://www.axsome.com

Axsome Therapeutics Website

Other Identifiers

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SOL-MDD-301

Identifier Type: -

Identifier Source: org_study_id

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