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
  Purpose

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


Condition Intervention Phase
Major Depressive Disorder
Drug: RX-10100
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 2 Study of RX-10100 in Subjects With Major Depressive Disorder.

Resource links provided by NLM:


Further study details as provided by Rexahn Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Change from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS)at week 9 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 314
Study Start Date: December 2010
Study Completion Date: October 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RX-10100 high dose

RX-10100

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

Drug: RX-10100
Extended-release tablet, taken twice daily for 8 weeks
Other Name: Serdaxin®
Experimental: RX-10100 low dose

RX-10100

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

Drug: RX-10100
Extended-release tablet, taken twice daily for 8 weeks
Other Name: Serdaxin®
Placebo Comparator: Placebo
Matching placebo is to be given orally, in tablet form, twice daily, for 8 weeks
Drug: RX-10100
Extended-release tablet, taken twice daily for 8 weeks
Other Name: Serdaxin®

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01273376

  Show 44 Study Locations
Sponsors and Collaborators
Rexahn Pharmaceuticals, Inc.
Investigators
Study Director: Christine Peterson, Ph.D Rexahn Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Rexahn Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01273376     History of Changes
Other Study ID Numbers: 2010MDD01
Study First Received: January 6, 2011
Last Updated: November 18, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Rexahn Pharmaceuticals, Inc.:
MDD
Depression
Major Depression

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on April 17, 2014