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NCT01273376 Clinical Trial

Safety and Efficacy of RX-10100 to Treat Major Depressive Disorder

Major Depressive Disorder Clinical Trial

— MDD  

Official title:
A Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 2 Study of RX-10100 in Subjects With Major Depressive Disorder.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01273376
Other study ID # 2010MDD01
Secondary ID
Status Completed
Phase Phase 2
First received January 6, 2011
Last updated November 18, 2013
Start date December 2010
Est. completion date October 2011

Study information
Verified date November 2013
Source Rexahn Pharmaceuticals, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationUnited States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether RX-10100 are effective in the treatment of Major Depressive Disorder (MDD).

Recruitment information / eligibility
Status Completed
Enrollment 314
Est. completion date October 2011
Est. primary completion date September 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• RX-10100
Extended-release tablet, taken twice daily for 8 weeks

Locations
Country Name City State
United States Rexahn Investigative Site Albuquerque New Mexico
United States Rexahn Investigative site Allentown Pennsylvania
United States Rexahn Investigative Site Anderson South Carolina
United States Rexahn Investigative Site Atlanta Georgia
United States Rexahn Investigative Site -2 Atlanta Georgia
United States Rexahn Investigative Site Austin Texas
United States Rexahn Investigative Site Bellevue Washington
United States Rexahn Investigative Site (2) Bellevue Washington
United States Rexahn Investigative Site Brooksville Florida
United States Rexahn Investigative Site Cerritos California
United States Rexahn Investigative site Cherry Hill New Jersey
United States Rexahn Investigative Site Cincinnati Ohio
United States Rexahn Investigative site Dallas Texas
United States Rexahn Investigative Site Dallas Texas
United States Rexahn Investigative Site Denver Colorado
United States Rexahn Investigative Site Escondido California
United States Rexahn Investigative Site Fresh Meadows New York
United States Rexahn Investigative Site Gainesville Florida
United States Rexahn Investigative site Garfield Heights Ohio
United States Rexahn Investigative Site Jacksonville Florida
United States Rexahn Investigative Sites Lake Jackson Texas
United States Rexahn Investigative Site Las Vegas Nevada
United States Rexahn Investigative Site Los Angeles California
United States Rexahn Investigative Site Media Pennsylvania
United States Rexahn Investigative Site Memphis Tennessee
United States Rexahn Investigative Site Miami Beach Florida
United States Rexahn Investigative Site National City California
United States Rexahn Investigative Site New York City New York
United States Rexahn Investigative Site Novi Michigan
United States Rexahn Investigative Site Oak Brook Illinois
United States Rexahn Investigative Site Oceanside California
United States Rexahn Investigative Site Oklahoma City Oklahoma
United States Rexahn Investigative Site Orange California
United States Rexahn Investigative Site Orem Utah
United States Rexahn Investigative Site Orlando Florida
United States Rexahn Investigative Site Owensboro Kentucky
United States Rexahn Investigative Site Richmond Virginia
United States Rexahn Investigative Site San Antonio Texas
United States Rexahn Investigative Site San Diego California
United States Rexahn Investigative Site Scranton Pennsylvania
United States Rexahn Investigative Site St. Petersburg Florida
United States Rexahn Investigative Site Tampa Florida
United States Rexahn Investigative Site The Woodlands Texas
United States Rexahn Investigative Site Vernon Hills Illinois

Sponsors (1)
Lead Sponsor Collaborator
Rexahn Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS)at week 9 8 weeks No
Secondary Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) at weeks 3, 5, and 7 8 weeks No
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