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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Depression
Depressive Disorder
Depressive Disorder, Major
Disease
Behavioral Symptoms
Mental Disorders
Mood Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2014