A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Treatment Resistant Major Depressive Disorder
NCT ID: NCT02741791
Last Updated: 2021-03-24
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
PHASE3
312 participants
INTERVENTIONAL
2016-03-31
2020-03-20
Brief Summary
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This is a randomized, double-blind, active-controlled, 12-week, two-period study consisting of an open-label, bupropion lead-in period, and a double-blind treatment period. The trial is being conducted in subjects with treatment resistant MDD.
Subjects will be considered to have treatment resistant MDD if they have had a historical inadequate response to 1 or 2 antidepressant treatments and a prospective inadequate response to treatment with bupropion during the open-label, lead-in period.
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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 6 weeks.
Bupropion
Bupropion
Buproprion taken daily for 6 weeks.
Interventions
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AXS-05
AXS-05 taken daily for 6 weeks.
Bupropion
Buproprion taken daily for 6 weeks.
Eligibility Criteria
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Inclusion Criteria
* History of inadequate response to 1 or 2 adequate antidepressant treatments
* Body mass index (BMI) between 18 and 40 kg/m2, inclusive
* Agree to use adequate method of contraception for the duration of the study
* Additional criteria may apply
Exclusion Criteria
* Treatment with any investigational drug within 6 months
* History of electroconvulsive therapy (ECT), vagus nerve stimulation, transcranial magnetic stimulation, or any experimental central nervous system treatment during the current episode or in the past 6 months
* Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study
* Additional criteria may apply
18 Years
65 Years
ALL
No
Sponsors
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Axsome Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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Phoenix, Arizona, United States
Little Rock, Arkansas, United States
Anaheim, California, United States
Beverly Hills, California, United States
Garden Grove, California, United States
Oakland, California, United States
Oceanside, California, United States
Panorama City, California, United States
Redlands, California, United States
Riverside, California, United States
San Diego, California, United States
San Francisco, California, United States
Sherman Oaks, California, United States
Temecula, California, United States
Upland, California, United States
Colorado Springs, Colorado, United States
Cromwell, Connecticut, United States
Washington D.C., District of Columbia, United States
Coral Springs, Florida, United States
Fort Lauderdale, Florida, United States
Fort Myers, Florida, United States
Gainesville, Florida, United States
Jacksonville, Florida, United States
Lakeland, Florida, United States
North Miami, Florida, United States
Orlando, Florida, United States
Pensacola, Florida, United States
St. Petersburg, Florida, United States
Atlanta, Georgia, United States
Boise, Idaho, United States
Skokie, Illinois, United States
Shreveport, Louisiana, United States
Baltimore, Maryland, United States
Saint Charles, Missouri, United States
St Louis, Missouri, United States
Lincoln, Nebraska, United States
Las Vegas, Nevada, United States
Nashua, New Hampshire, United States
Berlin, New Jersey, United States
Cherry Hill, New Jersey, United States
Marlton, New Jersey, United States
Princeton, New Jersey, United States
Toms River, New Jersey, United States
Albuquerque, New Mexico, United States
Brooklyn, New York, United States
Jamaica, New York, United States
New York, New York, United States
Rochester, New York, United States
Staten Island, New York, United States
Charlotte, North Carolina, United States
Canton, Ohio, United States
Dayton, Ohio, United States
Middleburg Heights, Ohio, United States
Oklahoma City, Oklahoma, United States
Portland, Oregon, United States
Salem, Oregon, United States
Allentown, Pennsylvania, United States
Media, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Lincoln, Rhode Island, United States
Charleston, South Carolina, United States
Memphis, Tennessee, United States
Austin, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Wichita Falls, Texas, United States
Orem, Utah, United States
Charlottesville, Virginia, United States
Herndon, Virginia, United States
Bellevue, Washington, United States
Seattle, Washington, United States
Spokane, Washington, United States
Waukesha, Wisconsin, United States
Countries
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Related Links
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www.TRDstudy.com
Other Identifiers
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AXS-05-301
Identifier Type: -
Identifier Source: org_study_id
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