Clinical trial NCT01273376: Safety and Efficacy of RX-10100 to Treat Major Depressive Disorder
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 2 Study of RX-10100 in Subjects With Major Depressive Disorder.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Major Depressive Disorder
Keywords: MDD
Depression
Major Depression
Lead sponsor: Rexahn Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2011-01-10
Enrollment: 314
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS)at week 9
timeFrame: 8 weeks
Secondary outcomes:
measure: Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) at weeks 3, 5, and 7
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Cerritos
country: United States
facility: Rexahn Investigative Site
state: California
city: Escondido
country: United States
facility: Rexahn Investigative Site
state: California
city: Los Angeles
country: United States
facility: Rexahn Investigative Site
state: California
city: National City
country: United States
facility: Rexahn Investigative Site
state: California
city: Oceanside
country: United States
facility: Rexahn Investigative Site
state: California
city: Orange
country: United States
facility: Rexahn Investigative Site
state: California
city: San Diego
country: United States
facility: Rexahn Investigative Site
state: California
city: Denver
country: United States
facility: Rexahn Investigative Site
state: Colorado
city: Brooksville
country: United States
facility: Rexahn Investigative Site
state: Florida
city: Gainesville
country: United States
facility: Rexahn Investigative Site
state: Florida
city: Jacksonville
country: United States
facility: Rexahn Investigative Site
state: Florida
city: Miami Beach
country: United States
facility: Rexahn Investigative Site
state: Florida
city: Orlando
country: United States
facility: Rexahn Investigative Site
state: Florida
city: St. Petersburg
country: United States
facility: Rexahn Investigative Site
state: Florida
city: Tampa
country: United States
facility: Rexahn Investigative Site
state: Florida
city: Atlanta
country: United States
facility: Rexahn Investigative Site -2
state: Georgia
city: Atlanta
country: United States
facility: Rexahn Investigative Site
state: Georgia
city: Oak Brook
country: United States
facility: Rexahn Investigative Site
state: Illinois
city: Vernon Hills
country: United States
facility: Rexahn Investigative Site
state: Illinois
city: Owensboro
country: United States
facility: Rexahn Investigative Site
state: Kentucky
city: Novi
country: United States
facility: Rexahn Investigative Site
state: Michigan
city: Las Vegas
country: United States
facility: Rexahn Investigative Site
state: Nevada
city: Cherry Hill
country: United States
facility: Rexahn Investigative site
state: New Jersey
city: Albuquerque
country: United States
facility: Rexahn Investigative Site
state: New Mexico
city: Fresh Meadows
country: United States
facility: Rexahn Investigative Site
state: New York
city: New York City
country: United States
facility: Rexahn Investigative Site
state: New York
city: Cincinnati
country: United States
facility: Rexahn Investigative Site
state: Ohio
city: Garfield Heights
country: United States
facility: Rexahn Investigative site
state: Ohio
city: Oklahoma City
country: United States
facility: Rexahn Investigative Site
state: Oklahoma
city: Allentown
country: United States
facility: Rexahn Investigative site
state: Pennsylvania
city: Media
country: United States
facility: Rexahn Investigative Site
state: Pennsylvania
city: Scranton
country: United States
facility: Rexahn Investigative Site
state: Pennsylvania
city: Anderson
country: United States
facility: Rexahn Investigative Site
state: South Carolina
city: Memphis
country: United States
facility: Rexahn Investigative Site
state: Tennessee
city: Austin
country: United States
facility: Rexahn Investigative Site
state: Texas
city: Dallas
country: United States
facility: Rexahn Investigative site
state: Texas
city: Dallas
country: United States
facility: Rexahn Investigative Site
state: Texas
city: Lake Jackson
country: United States
facility: Rexahn Investigative Sites
state: Texas
city: San Antonio
country: United States
facility: Rexahn Investigative Site
state: Texas
city: The Woodlands
country: United States
facility: Rexahn Investigative Site
state: Texas
city: Orem
country: United States
facility: Rexahn Investigative Site
state: Utah
city: Richmond
country: United States
facility: Rexahn Investigative Site
state: Virginia
city: Bellevue
country: United States
facility: Rexahn Investigative Site (2)
state: Washington
city: Bellevue
country: United States
facility: Rexahn Investigative Site
state: Washington
Study officials:
affiliation: Rexahn Pharmaceuticals, Inc.
name: Christine Peterson, Ph.D
role: STUDY_DIRECTOR
References: