Safety and Efficacy of RX-10100 to Treat Major Depressive Disorder
MDD
A Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 2 Study of RX-10100 in Subjects With Major Depressive Disorder.
1 other identifier
interventional
314
1 country
44
Brief Summary
The purpose of this study is to determine whether RX-10100 are effective in the treatment of Major Depressive Disorder (MDD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 major-depressive-disorder
Started Dec 2010
Shorter than P25 for phase_2 major-depressive-disorder
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 6, 2011
CompletedFirst Posted
Study publicly available on registry
January 10, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedNovember 19, 2013
November 1, 2013
9 months
January 6, 2011
November 18, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS)at week 9
8 weeks
Secondary Outcomes (1)
Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) at weeks 3, 5, and 7
8 weeks
Study Arms (3)
RX-10100 high dose
EXPERIMENTALRX-10100 Study drug is to be given orally, in tablet form, twice daily, for 8 weeks
RX-10100 low dose
EXPERIMENTALRX-10100 Study drug is to be given orally, in tablet form, twice daily, for 8 weeks
Placebo
PLACEBO COMPARATORMatching placebo is to be given orally, in tablet form, twice daily, for 8 weeks
Interventions
Extended-release tablet, taken twice daily for 8 weeks
Eligibility Criteria
You may qualify if:
- Moderate to severe MDD as determined by the DSM-IV-TR Axis 1 Disorders and by the Montgomery Asberg Depression Rating Scale (MADRS).
You may not qualify if:
- Women who are pregnant, women who will be breastfeeding during the study, and women with childbearing potential who are not willing to practice a reliable method of birth control
- Depressive episode duration of less than 1 month
- Lifetime history of any psychotic disorders
- Anxiety disorders
- Significant suicidality
- Clinically significant medical conditions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (44)
Rexahn Investigative Site
Cerritos, California, 90703, United States
Rexahn Investigative Site
Escondido, California, 92025, United States
Rexahn Investigative Site
Los Angeles, California, 90024, United States
Rexahn Investigative Site
National City, California, 91950, United States
Rexahn Investigative Site
Oceanside, California, 92056, United States
Rexahn Investigative Site
Orange, California, 92868, United States
Rexahn Investigative Site
San Diego, California, 92123, United States
Rexahn Investigative Site
Denver, Colorado, 82039, United States
Rexahn Investigative Site
Brooksville, Florida, 34601, United States
Rexahn Investigative Site
Gainesville, Florida, 32607, United States
Rexahn Investigative Site
Jacksonville, Florida, 32216, United States
Rexahn Investigative Site
Miami Beach, Florida, 33139, United States
Rexahn Investigative Site
Orlando, Florida, 32806, United States
Rexahn Investigative Site
St. Petersburg, Florida, 33709, United States
Rexahn Investigative Site
Tampa, Florida, 33606, United States
Rexahn Investigative Site -2
Atlanta, Georgia, 30328, United States
Rexahn Investigative Site
Atlanta, Georgia, 30328, United States
Rexahn Investigative Site
Oak Brook, Illinois, 60523, United States
Rexahn Investigative Site
Vernon Hills, Illinois, 60061, United States
Rexahn Investigative Site
Owensboro, Kentucky, 42301, United States
Rexahn Investigative Site
Novi, Michigan, 48377, United States
Rexahn Investigative Site
Las Vegas, Nevada, 89146, United States
Rexahn Investigative site
Cherry Hill, New Jersey, 08002, United States
Rexahn Investigative Site
Albuquerque, New Mexico, 87109, United States
Rexahn Investigative Site
Fresh Meadows, New York, 11366, United States
Rexahn Investigative Site
New York, New York, 10021, United States
Rexahn Investigative Site
Cincinnati, Ohio, 45227, United States
Rexahn Investigative site
Garfield Heights, Ohio, 44125, United States
Rexahn Investigative Site
Oklahoma City, Oklahoma, 73103, United States
Rexahn Investigative site
Allentown, Pennsylvania, 18103, United States
Rexahn Investigative Site
Media, Pennsylvania, 19063, United States
Rexahn Investigative Site
Scranton, Pennsylvania, 18503, United States
Rexahn Investigative Site
Anderson, South Carolina, 29621, United States
Rexahn Investigative Site
Memphis, Tennessee, 38119, United States
Rexahn Investigative Site
Austin, Texas, 78756, United States
Rexahn Investigative site
Dallas, Texas, 75231, United States
Rexahn Investigative Site
Dallas, Texas, 75390, United States
Rexahn Investigative Sites
Lake Jackson, Texas, 77566, United States
Rexahn Investigative Site
San Antonio, Texas, 78229, United States
Rexahn Investigative Site
The Woodlands, Texas, 77381, United States
Rexahn Investigative Site
Orem, Utah, 84058, United States
Rexahn Investigative Site
Richmond, Virginia, 23284, United States
Rexahn Investigative Site (2)
Bellevue, Washington, 98007, United States
Rexahn Investigative Site
Bellevue, Washington, 98007, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Christine Peterson, Ph.D
Rexahn Pharmaceuticals, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 6, 2011
First Posted
January 10, 2011
Study Start
December 1, 2010
Primary Completion
September 1, 2011
Study Completion
October 1, 2011
Last Updated
November 19, 2013
Record last verified: 2013-11