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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01273376
First Posted: January 10, 2011
Last Update Posted: November 19, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Rexahn Pharmaceuticals, Inc.
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]

Secondary Outcome Measures:
  • Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) at weeks 3, 5, and 7 [ Time Frame: 8 weeks ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01273376


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

Responsible Party: Rexahn Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01273376     History of Changes
Other Study ID Numbers: 2010MDD01
First Submitted: January 6, 2011
First Posted: January 10, 2011
Last Update Posted: November 19, 2013
Last Verified: November 2013

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

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