Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
44 participants
INTERVENTIONAL
2020-08-13
2021-07-30
Brief Summary
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This is a randomized, double-blind, placebo-controlled study to evaluate AXS-05 compared to placebo in delaying relapse of depressive symptoms in patients with TRD who are in stable remission after treatment with AXS-05.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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AXS-05
AXS-05
AXS-05 taken daily for up to 52 weeks, until relapse.
Placebo
Placebo
Placebo taken daily for up to 52 weeks, until relapse.
Interventions
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AXS-05
AXS-05 taken daily for up to 52 weeks, until relapse.
Placebo
Placebo taken daily for up to 52 weeks, until relapse.
Eligibility Criteria
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Inclusion Criteria
* Ongoing symptoms of depression despite receiving treatment with two or more prior antidepressants during the current major depressive episode, prior to receiving AXS-05
* Agree to use adequate method of contraception for the duration of the study
* Additional criteria may apply
18 Years
ALL
No
Sponsors
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Axsome Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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Clinical Research Site
Little Rock, Arkansas, United States
Clinical Research Site
Redlands, California, United States
Clinical Research Site
Sherman Oaks, California, United States
Clinical Research Site
Upland, California, United States
Clinical Research Site
Miami, Florida, United States
Clinical Research Site
North Miami, Florida, United States
Clinical Research Site
Orlando, Florida, United States
Clinical Research Site
Chicago, Illinois, United States
Clinical Research Site
Boston, Massachusetts, United States
Clinical Research Site
Berlin, New Jersey, United States
Clinical Research Site
Rochester, New York, United States
Clinical Research Site
Staten Island, New York, United States
Clinical Research Site
Hickory, North Carolina, United States
Clinical Research Site
Raleigh, North Carolina, United States
Clinical Research Site
Cincinnati, Ohio, United States
Clinical Research Site
Middleburg Heights, Ohio, United States
Clinical Research Site
Media, Pennsylvania, United States
Clinical Research Site
Dallas, Texas, United States
Clinical Research Site
Houston, Texas, United States
Clinical Research Site
Everett, Washington, United States
Countries
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Related Links
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Axsome Therapeutics Website
Other Identifiers
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AXS-05-TRD-201
Identifier Type: -
Identifier Source: org_study_id
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