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Completed

NCT Number: NCT06360419

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

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.

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Clinical Research Site, Little Rock, Arkansas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Solriamfetol 300 mg

Drug

Solriamfetol tablets, taken once daily

Placebo

Drug

Placebo tablets, taken once daily

Primary outcomes

  1. Montgomery-Åsberg Depression Rating Scale (MADRS)

    Time frame: 6 weeks

  2. Incidence of treatment-emergent adverse events

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Axsome Therapeutics, Inc.

Industry

Registry information

Official study title

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

Acronym: PARADIGM

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Apr 11, 2024
Registry last updated
Jan 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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