Safety and Efficacy of RX-10100 to Treat Major Depressive Disorder
- Registration Number
- NCT01273376
- Lead Sponsor
- Rexahn Pharmaceuticals, Inc.
- Brief Summary
The purpose of this study is to determine whether RX-10100 are effective in the treatment of Major Depressive Disorder (MDD).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 314
Inclusion Criteria
• Moderate to severe MDD as determined by the DSM-IV-TR Axis 1 Disorders and by the Montgomery Asberg Depression Rating Scale (MADRS).
Exclusion Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description RX-10100 high dose RX-10100 RX-10100 Study drug is to be given orally, in tablet form, twice daily, for 8 weeks RX-10100 low dose RX-10100 RX-10100 Study drug is to be given orally, in tablet form, twice daily, for 8 weeks Placebo RX-10100 Matching placebo is to be given orally, in tablet form, twice daily, for 8 weeks
- Primary Outcome Measures
Name Time Method Change from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS)at week 9 8 weeks
- Secondary Outcome Measures
Name Time Method Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) at weeks 3, 5, and 7 8 weeks
Trial Locations
- Locations (5)
Rexahn Investigative Site
🇺🇸Bellevue, Washington, United States
Rexahn Investigative Site (2)
🇺🇸Bellevue, Washington, United States
Rexahn Investigative Sites
🇺🇸Lake Jackson, Texas, United States
Rexahn Investigative Site -2
🇺🇸Atlanta, Georgia, United States
Rexahn Investigative site
🇺🇸Dallas, Texas, United States