Progressing TAAR-1, Dopamine, and Norepinephrine in Depression Using Solriamfetol
PARADIGM
A Randomized, Double-Blind, Placebo-Controlled Trial of Solriamfetol in Subjects With Major Depressive Disorder
1 other identifier
interventional
346
1 country
40
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 major-depressive-disorder
Started Mar 2024
Shorter than P25 for phase_3 major-depressive-disorder
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 18, 2024
CompletedFirst Submitted
Initial submission to the registry
April 8, 2024
CompletedFirst Posted
Study publicly available on registry
April 11, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 26, 2025
CompletedJanuary 5, 2026
December 1, 2025
10 months
April 8, 2024
December 30, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Montgomery-Ă…sberg Depression Rating Scale (MADRS)
6 weeks
Incidence of treatment-emergent adverse events
6 weeks
Study Arms (2)
Solriamfetol 300 mg
EXPERIMENTALUp to 6 weeks
Placebo
PLACEBO COMPARATORUp to 6 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (40)
Clinical Research Site
Little Rock, Arkansas, 72211, United States
Clinical Research Site
Bellflower, California, 90706, United States
Clinical Research Site
Encino, California, 91316, United States
Clinical Research Site
Lemon Grove, California, 91945, United States
Clinical Research Site
Los Angeles, California, 90015, United States
Clinical Research Site
Montclair, California, 91763, United States
Clinical Research Site
Oceanside, California, 92056, United States
Clinical Research Site
Redlands, California, 92374, United States
Clinical Research Site
Riverside, California, 92506, United States
Clinical Research Site
Sherman Oaks, California, 91403, United States
Clinical Research Site
Torrance, California, 90501, United States
Clinical Research Site
Upland, California, 91786, United States
Clinical Research Site
Walnut Creek, California, 94596, United States
Clinical Research Site
Cromwell, Connecticut, 06416, United States
Clinical Research Site
Brandon, Florida, 33511, United States
Clinical Research Site
Hialeah, Florida, 33012, United States
Clinical Research Site
Jacksonville, Florida, 32256, United States
Clinical Research Site
Orlando, Florida, 32801, United States
Clinical Research Site
Orlando, Florida, 32806, United States
Clinical Research Site
Orlando, Florida, 32807, United States
Clinical Research Site
Chicago, Illinois, 60634, United States
Clinical Research Site
Overland Park, Kansas, 66210, United States
Clinical Research Site
New Orleans, Louisiana, 70115, United States
Clinical Research Site
Boston, Massachusetts, 02131, United States
Clinical Research Site
Saint Charles, Missouri, 63304, United States
Clinical Research Site
Las Vegas, Nevada, 89102, United States
Clinical Research Site
Brooklyn, New York, 11235, United States
Clinical Research Site
Rochester, New York, 14609, United States
Clinical Research Site
Staten Island, New York, 10314, United States
Clinical Research Site
Hickory, North Carolina, 28601, United States
Clinical Research Site
Cincinnati, Ohio, 45215, United States
Clinical Research Site
Oklahoma City, Oklahoma, 73116, United States
Clinical Research Site
Media, Pennsylvania, 19063, United States
Clinical Research Site
Philadelphia, Pennsylvania, 19104, United States
Clinical Research Site
Memphis, Tennessee, 38119, United States
Clinical Research Site
Austin, Texas, 78737, United States
Clinical Research Site
Dallas, Texas, 75231, United States
Clinical Research Site
Friendswood, Texas, 77546, United States
Clinical Research Site
Wichita Falls, Texas, 76309, United States
Clinical Research Site
Everett, Washington, 98201, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 8, 2024
First Posted
April 11, 2024
Study Start
March 18, 2024
Primary Completion
December 31, 2024
Study Completion
March 26, 2025
Last Updated
January 5, 2026
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share