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

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ClinicalTrials.gov Identifier: NCT01273376
Recruitment Status : Completed
First Posted : January 10, 2011
Last Update Posted : November 19, 2013
Sponsor:
Information provided by (Responsible Party):
Rexahn Pharmaceuticals, Inc.

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

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: RX-10100 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 314 participants
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.
Study Start Date : December 2010
Actual Primary Completion Date : September 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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®




Primary Outcome Measures :
  1. Change from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS)at week 9 [ Time Frame: 8 weeks ]

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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

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.

Responsible Party: Rexahn Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01273376     History of Changes
Other Study ID Numbers: 2010MDD01
First Posted: January 10, 2011    Key Record Dates
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