Clinical trial NCT06360419: Progressing TAAR-1, Dopamine, and Norepinephrine in Depression Using Solriamfetol
Official title: A Randomized, Double-Blind, Placebo-Controlled Trial of Solriamfetol in Subjects With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Keywords: Solriamfetol
Sunosi
MDD
Major Depressive Disorder
Axsome
Non-stimulant therapy
Dopamine norepinephrine reuptake inhibitor
Trace amine-associated receptor 1 (TAAR1) agonist
Lead sponsor: Axsome Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2024-04-11
Enrollment: 346
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Montgomery-Åsberg Depression Rating Scale (MADRS)
timeFrame: 6 weeks
measure: Incidence of treatment-emergent adverse events
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Clinical Research Site
state: Arkansas
city: Bellflower
country: United States
facility: Clinical Research Site
state: California
city: Encino
country: United States
facility: Clinical Research Site
state: California
city: Lemon Grove
country: United States
facility: Clinical Research Site
state: California
city: Los Angeles
country: United States
facility: Clinical Research Site
state: California
city: Montclair
country: United States
facility: Clinical Research Site
state: California
city: Oceanside
country: United States
facility: Clinical Research Site
state: California
city: Redlands
country: United States
facility: Clinical Research Site
state: California
city: Riverside
country: United States
facility: Clinical Research Site
state: California
city: Sherman Oaks
country: United States
facility: Clinical Research Site
state: California
city: Torrance
country: United States
facility: Clinical Research Site
state: California
city: Upland
country: United States
facility: Clinical Research Site
state: California
city: Walnut Creek
country: United States
facility: Clinical Research Site
state: California
city: Cromwell
country: United States
facility: Clinical Research Site
state: Connecticut
city: Brandon
country: United States
facility: Clinical Research Site
state: Florida
city: Hialeah
country: United States
facility: Clinical Research Site
state: Florida
city: Jacksonville
country: United States
facility: Clinical Research Site
state: Florida
city: Orlando
country: United States
facility: Clinical Research Site
state: Florida
city: Orlando
country: United States
facility: Clinical Research Site
state: Florida
city: Orlando
country: United States
facility: Clinical Research Site
state: Florida
city: Chicago
country: United States
facility: Clinical Research Site
state: Illinois
city: Overland Park
country: United States
facility: Clinical Research Site
state: Kansas
city: New Orleans
country: United States
facility: Clinical Research Site
state: Louisiana
city: Boston
country: United States
facility: Clinical Research Site
state: Massachusetts
city: Saint Charles
country: United States
facility: Clinical Research Site
state: Missouri
city: Las Vegas
country: United States
facility: Clinical Research Site
state: Nevada
city: Brooklyn
country: United States
facility: Clinical Research Site
state: New York
city: Rochester
country: United States
facility: Clinical Research Site
state: New York
city: Staten Island
country: United States
facility: Clinical Research Site
state: New York
city: Hickory
country: United States
facility: Clinical Research Site
state: North Carolina
city: Cincinnati
country: United States
facility: Clinical Research Site
state: Ohio
city: Oklahoma City
country: United States
facility: Clinical Research Site
state: Oklahoma
city: Media
country: United States
facility: Clinical Research Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Clinical Research Site
state: Pennsylvania
city: Memphis
country: United States
facility: Clinical Research Site
state: Tennessee
city: Austin
country: United States
facility: Clinical Research Site
state: Texas
city: Dallas
country: United States
facility: Clinical Research Site
state: Texas
city: Friendswood
country: United States
facility: Clinical Research Site
state: Texas
city: Wichita Falls
country: United States
facility: Clinical Research Site
state: Texas
city: Everett
country: United States
facility: Clinical Research Site
state: Washington
Study officials:
References: