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

Axsome Therapeutics

Status and phase: Completed; Phase 3

Conditions: Major Depressive Disorder

Treatments: Drug: Solriamfetol 300 mg; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06360419

SOL-MDD-301

Details and patient eligibility

About

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.

Full 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.

Enrollment: 346 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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346 participants in 2 patient groups, including a placebo group

Solriamfetol 300 mg

Experimental group

Description:

Up to 6 weeks

Treatment:

Drug: Solriamfetol 300 mg

Placebo

Placebo Comparator group

Description:

Up to 6 weeks

Treatment:

Drug: Placebo