Safety and Efficacy of RX-10100 to Treat Major Depressive Disorder
NCT ID: NCT01273376
Last Updated: 2013-11-19
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
314 participants
INTERVENTIONAL
2010-12-31
2011-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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RX-10100 high dose
RX-10100
Study drug is to be given orally, in tablet form, twice daily, for 8 weeks
RX-10100
Extended-release tablet, taken twice daily for 8 weeks
RX-10100 low dose
RX-10100
Study drug is to be given orally, in tablet form, twice daily, for 8 weeks
RX-10100
Extended-release tablet, taken twice daily for 8 weeks
Placebo
Matching placebo is to be given orally, in tablet form, twice daily, for 8 weeks
RX-10100
Extended-release tablet, taken twice daily for 8 weeks
Interventions
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RX-10100
Extended-release tablet, taken twice daily for 8 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Depressive episode duration of less than 1 month
* Lifetime history of any psychotic disorders
* Anxiety disorders
* Significant suicidality
* Clinically significant medical conditions
18 Years
65 Years
ALL
No
Sponsors
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Rexahn Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Christine Peterson, Ph.D
Role: STUDY_DIRECTOR
Rexahn Pharmaceuticals, Inc.
Locations
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Rexahn Investigative Site
Cerritos, California, United States
Rexahn Investigative Site
Escondido, California, United States
Rexahn Investigative Site
Los Angeles, California, United States
Rexahn Investigative Site
National City, California, United States
Rexahn Investigative Site
Oceanside, California, United States
Rexahn Investigative Site
Orange, California, United States
Rexahn Investigative Site
San Diego, California, United States
Rexahn Investigative Site
Denver, Colorado, United States
Rexahn Investigative Site
Brooksville, Florida, United States
Rexahn Investigative Site
Gainesville, Florida, United States
Rexahn Investigative Site
Jacksonville, Florida, United States
Rexahn Investigative Site
Miami Beach, Florida, United States
Rexahn Investigative Site
Orlando, Florida, United States
Rexahn Investigative Site
St. Petersburg, Florida, United States
Rexahn Investigative Site
Tampa, Florida, United States
Rexahn Investigative Site -2
Atlanta, Georgia, United States
Rexahn Investigative Site
Atlanta, Georgia, United States
Rexahn Investigative Site
Oak Brook, Illinois, United States
Rexahn Investigative Site
Vernon Hills, Illinois, United States
Rexahn Investigative Site
Owensboro, Kentucky, United States
Rexahn Investigative Site
Novi, Michigan, United States
Rexahn Investigative Site
Las Vegas, Nevada, United States
Rexahn Investigative site
Cherry Hill, New Jersey, United States
Rexahn Investigative Site
Albuquerque, New Mexico, United States
Rexahn Investigative Site
Fresh Meadows, New York, United States
Rexahn Investigative Site
New York, New York, United States
Rexahn Investigative Site
Cincinnati, Ohio, United States
Rexahn Investigative site
Garfield Heights, Ohio, United States
Rexahn Investigative Site
Oklahoma City, Oklahoma, United States
Rexahn Investigative site
Allentown, Pennsylvania, United States
Rexahn Investigative Site
Media, Pennsylvania, United States
Rexahn Investigative Site
Scranton, Pennsylvania, United States
Rexahn Investigative Site
Anderson, South Carolina, United States
Rexahn Investigative Site
Memphis, Tennessee, United States
Rexahn Investigative Site
Austin, Texas, United States
Rexahn Investigative site
Dallas, Texas, United States
Rexahn Investigative Site
Dallas, Texas, United States
Rexahn Investigative Sites
Lake Jackson, Texas, United States
Rexahn Investigative Site
San Antonio, Texas, United States
Rexahn Investigative Site
The Woodlands, Texas, United States
Rexahn Investigative Site
Orem, Utah, United States
Rexahn Investigative Site
Richmond, Virginia, United States
Rexahn Investigative Site (2)
Bellevue, Washington, United States
Rexahn Investigative Site
Bellevue, Washington, United States
Countries
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Other Identifiers
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2010MDD01
Identifier Type: -
Identifier Source: org_study_id