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

April 8, 2024 updated by: Axsome Therapeutics, Inc.

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Encino, California, United States, 91316
        • Recruiting
        • Clinical Research Site
      • Lemon Grove, California, United States, 91945
        • Recruiting
        • Clinical Research Site
      • Oceanside, California, United States, 92056
        • Recruiting
        • Clinical Research Site
      • Redlands, California, United States, 92374
        • Recruiting
        • Clinical Research Site
      • Riverside, California, United States, 92506
        • Recruiting
        • Clinical Research Site
      • Sherman Oaks, California, United States, 91403
        • Recruiting
        • Clinical Research Site
      • Upland, California, United States, 91786
        • Recruiting
        • Clinical Research Site
    • Connecticut
      • Cromwell, Connecticut, United States, 06416
        • Recruiting
        • Clinical Research Site
    • Florida
      • Hialeah, Florida, United States, 33012
        • Recruiting
        • Clinical Research Site
      • Jacksonville, Florida, United States, 32256
        • Recruiting
        • Clinical Research Site
      • Orlando, Florida, United States, 32801
        • Recruiting
        • Clinical Research Site
      • Orlando, Florida, United States, 32806
        • Recruiting
        • Clinical Research Site
      • Orlando, Florida, United States, 32807
        • Recruiting
        • Clinical Research Site
    • Illinois
      • Chicago, Illinois, United States, 60634
        • Recruiting
        • Clinical Research Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02131
        • Recruiting
        • Clinical Research Site
    • Missouri
      • Saint Charles, Missouri, United States, 63304
        • Recruiting
        • Clinical Research Site
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Recruiting
        • Clinical Research Site
    • New York
      • Brooklyn, New York, United States, 11235
        • Recruiting
        • Clinical Research Site
      • Rochester, New York, United States, 14609
        • Recruiting
        • Clinical Research Site
    • North Carolina
      • Hickory, North Carolina, United States, 28601
        • Recruiting
        • Clinical Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73118
        • Recruiting
        • Clinical Research Site
    • Pennsylvania
      • Media, Pennsylvania, United States, 19063
        • Recruiting
        • Clinical Research Site
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Recruiting
        • Clinical Research Site
    • Texas
      • Wichita Falls, Texas, United States, 76309
        • Recruiting
        • Clinical Research Site
    • Washington
      • Everett, Washington, United States, 98201
        • Recruiting
        • Clinical Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Solriamfetol 300 mg
Up to 6 weeks
Drug: Solriamfetol 300 mg
Solriamfetol tablets, taken once daily
Placebo Comparator: Placebo
Up to 6 weeks
Drug: Placebo
Placebo tablets, taken once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Montgomery-Åsberg Depression Rating Scale (MADRS)
Time Frame: 6 weeks
6 weeks
Incidence of treatment-emergent adverse events
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Axsome Therapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 18, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

April 8, 2024

First Submitted That Met QC Criteria

April 8, 2024

First Posted (Actual)

April 11, 2024

Study Record Updates

Last Update Posted (Actual)

April 11, 2024

Last Update Submitted That Met QC Criteria

April 8, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SOL-MDD-301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Major Depressive Disorder

Clinical Trials on Solriamfetol 300 mg

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Arab Emirates

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe