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NCT06223880RecruitingPhase 4

A Study to Evaluate the Efficacy of AXS-05 Compared to Bupropion in Preventing the Relapse of Depressive Symptoms

A Randomized, Double-blind, Active-controlled Study of AXS-05 for the Prevention of Relapse of Depressive Symptoms

Source: ClinicalTrials.gov · Last updated 23 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

This is a randomized, double-blind, active-controlled, multi-center study to evaluate the efficacy of AXS-05, compared to bupropion, in preventing the relapse of depressive symptoms in subjects with major depressive disorder (MDD) who have responded to treatment with AXS-05.

Status (registry)
Recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
350 (estimated)
First submitted
16 Jan 2024
Start date
27 Dec 2023
Primary completion date
Mar 2026
Lead sponsor
Axsome Therapeutics, Inc.
Diseases
Depression
NCT number
NCT06223880

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 350
  • From 27 Dec 2023 to the primary completion date, Mar 2026
  • 37 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

  • Previously participated in another clinical study of AXS-05; received any investigational drug or device treatment within 30 days of (Screening) Visit 1, or has been prescribed Auvelity.

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 DSM-5 criteria for diagnosis of MDD without psychotic features
  • Current major depressive episode of at least 4 weeks in duration

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

Full criteria on ClinicalTrials.gov

Sites (37)

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

SiteCityCountrySite status
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AtlantaUnited StatesRecruiting
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BellflowerUnited StatesRecruiting
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BostonUnited StatesRecruiting
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BrandonUnited StatesRecruiting
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BrooklynUnited StatesRecruiting
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Cherry HillUnited StatesRecruiting
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ChicagoUnited StatesRecruiting
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CincinnatiUnited StatesRecruiting
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DallasUnited StatesRecruiting
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DoralUnited StatesRecruiting
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EdmondUnited StatesRecruiting
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EverettUnited StatesRecruiting
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FriendswoodUnited StatesRecruiting
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HialeahUnited StatesRecruiting
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HickoryUnited StatesRecruiting
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JacksonvilleUnited StatesRecruiting
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LafayetteUnited StatesRecruiting
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Las VegasUnited StatesRecruiting
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MemphisUnited StatesRecruiting
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MiamiUnited StatesRecruiting
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Mount KiscoUnited StatesRecruiting
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New OrleansUnited StatesRecruiting
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New YorkUnited StatesRecruiting
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OceansideUnited StatesRecruiting
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Oklahoma CityUnited StatesRecruiting
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OrlandoUnited StatesRecruiting
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Overland ParkUnited StatesRecruiting
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PortlandUnited StatesRecruiting
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RedlandsUnited StatesRecruiting
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RiversideUnited StatesRecruiting
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Saint CharlesUnited StatesRecruiting
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San AntonioUnited StatesRecruiting
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San DiegoUnited StatesRecruiting
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Staten IslandUnited StatesRecruiting
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Toms RiverUnited StatesRecruiting
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UplandUnited StatesRecruiting
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Wichita FallsUnited StatesRecruiting

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