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NCT06360419CompletedPhase 3

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

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

Source: ClinicalTrials.gov · Last updated 5 Jan 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
346 (actual)
First submitted
8 Apr 2024
Start date
18 Mar 2024
Primary completion date
31 Dec 2024
Lead sponsor
Axsome Therapeutics, Inc.
Diseases
Depression
NCT number
NCT06360419

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 346
  • From 18 Mar 2024 to the primary completion date, 31 Dec 2024
  • 38 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior exposure to solriamfetol/Sunosi, through either a clinical study or prescription

Other

  • Unable to comply with study procedures
  • Medically inappropriate for study participation in the opinion of the investigator

Who the study is looking for

  • 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

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (38)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Clinical Research Site
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AustinUnited StatesUnknown status
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BellflowerUnited StatesUnknown status
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BostonUnited StatesUnknown status
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BrandonUnited StatesUnknown status
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BrooklynUnited StatesUnknown status
Clinical Research Site
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ChicagoUnited StatesUnknown status
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CincinnatiUnited StatesUnknown status
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CromwellUnited StatesUnknown status
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DallasUnited StatesUnknown status
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EncinoUnited StatesUnknown status
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EverettUnited StatesUnknown status
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FriendswoodUnited StatesUnknown status
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HialeahUnited StatesUnknown status
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HickoryUnited StatesUnknown status
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JacksonvilleUnited StatesUnknown status
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Las VegasUnited StatesUnknown status
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Lemon GroveUnited StatesUnknown status
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Little RockUnited StatesUnknown status
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Los AngelesUnited StatesUnknown status
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MediaUnited StatesUnknown status
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MemphisUnited StatesUnknown status
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MontclairUnited StatesUnknown status
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New OrleansUnited StatesUnknown status
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OceansideUnited StatesUnknown status
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Oklahoma CityUnited StatesUnknown status
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OrlandoUnited StatesUnknown status
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Overland ParkUnited StatesUnknown status
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PhiladelphiaUnited StatesUnknown status
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RedlandsUnited StatesUnknown status
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RiversideUnited StatesUnknown status
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RochesterUnited StatesUnknown status
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Saint CharlesUnited StatesUnknown status
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Sherman OaksUnited StatesUnknown status
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Staten IslandUnited StatesUnknown status
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TorranceUnited StatesUnknown status
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UplandUnited StatesUnknown status
Clinical Research Site
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Walnut CreekUnited StatesUnknown status
Clinical Research Site
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Wichita FallsUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.