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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rexahn Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01273376
First received: January 6, 2011
Last updated: November 18, 2013
Last verified: November 2013

January 6, 2011
November 18, 2013
December 2010
September 2011   (final data collection date for primary outcome measure)
Change from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS)at week 9 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01273376 on ClinicalTrials.gov Archive Site
Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) at weeks 3, 5, and 7 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Safety and Efficacy of RX-10100 to Treat Major Depressive Disorder
A Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 2 Study of RX-10100 in Subjects With Major Depressive Disorder.

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Major Depressive Disorder
Drug: RX-10100
Extended-release tablet, taken twice daily for 8 weeks
Other Name: Serdaxin®
  • Experimental: RX-10100 high dose

    RX-10100

    Study drug is to be given orally, in tablet form, twice daily, for 8 weeks

    Intervention: Drug: RX-10100
  • Experimental: RX-10100 low dose

    RX-10100

    Study drug is to be given orally, in tablet form, twice daily, for 8 weeks

    Intervention: Drug: RX-10100
  • Placebo Comparator: Placebo
    Matching placebo is to be given orally, in tablet form, twice daily, for 8 weeks
    Intervention: Drug: RX-10100
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
314
October 2011
September 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01273376
2010MDD01
Yes
Rexahn Pharmaceuticals, Inc.
Rexahn Pharmaceuticals, Inc.
Not Provided
Study Director: Christine Peterson, Ph.D Rexahn Pharmaceuticals, Inc.
Rexahn Pharmaceuticals, Inc.
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP