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

November 18, 2013 updated by: Rexahn Pharmaceuticals, Inc.

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

314

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Cerritos, California, United States, 90703
        • Rexahn Investigative Site
      • Escondido, California, United States, 92025
        • Rexahn Investigative Site
      • Los Angeles, California, United States, 90024
        • Rexahn Investigative Site
      • National City, California, United States, 91950
        • Rexahn Investigative Site
      • Oceanside, California, United States, 92056
        • Rexahn Investigative Site
      • Orange, California, United States, 92868
        • Rexahn Investigative Site
      • San Diego, California, United States, 92123
        • Rexahn Investigative Site
    • Colorado
      • Denver, Colorado, United States, 82039
        • Rexahn Investigative Site
    • Florida
      • Brooksville, Florida, United States, 34601
        • Rexahn Investigative Site
      • Gainesville, Florida, United States, 32607
        • Rexahn Investigative Site
      • Jacksonville, Florida, United States, 32216
        • Rexahn Investigative Site
      • Miami Beach, Florida, United States, 33139
        • Rexahn Investigative Site
      • Orlando, Florida, United States, 32806
        • Rexahn Investigative Site
      • St. Petersburg, Florida, United States, 33709
        • Rexahn Investigative Site
      • Tampa, Florida, United States, 33606
        • Rexahn Investigative Site
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Rexahn Investigative Site -2
      • Atlanta, Georgia, United States, 30328
        • Rexahn Investigative Site
    • Illinois
      • Oak Brook, Illinois, United States, 60523
        • Rexahn Investigative Site
      • Vernon Hills, Illinois, United States, 60061
        • Rexahn Investigative Site
    • Kentucky
      • Owensboro, Kentucky, United States, 42301
        • Rexahn Investigative Site
    • Michigan
      • Novi, Michigan, United States, 48377
        • Rexahn Investigative Site
    • Nevada
      • Las Vegas, Nevada, United States, 89146
        • Rexahn Investigative Site
    • New Jersey
      • Cherry Hill, New Jersey, United States, 08002
        • Rexahn Investigative Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Rexahn Investigative Site
    • New York
      • Fresh Meadows, New York, United States, 11366
        • Rexahn Investigative Site
      • New York City, New York, United States, 10021
        • Rexahn Investigative Site
    • Ohio
      • Cincinnati, Ohio, United States, 45227
        • Rexahn Investigative Site
      • Garfield Heights, Ohio, United States, 44125
        • Rexahn Investigative Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • Rexahn Investigative Site
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Rexahn Investigative Site
      • Media, Pennsylvania, United States, 19063
        • Rexahn Investigative Site
      • Scranton, Pennsylvania, United States, 18503
        • Rexahn Investigative Site
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • Rexahn Investigative Site
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Rexahn Investigative Site
    • Texas
      • Austin, Texas, United States, 78756
        • Rexahn Investigative Site
      • Dallas, Texas, United States, 75231
        • Rexahn Investigative Site
      • Dallas, Texas, United States, 75390
        • Rexahn Investigative Site
      • Lake Jackson, Texas, United States, 77566
        • Rexahn Investigative Sites
      • San Antonio, Texas, United States, 78229
        • Rexahn Investigative Site
      • The Woodlands, Texas, United States, 77381
        • Rexahn Investigative Site
    • Utah
      • Orem, Utah, United States, 84058
        • Rexahn Investigative Site
    • Virginia
      • Richmond, Virginia, United States, 23284
        • Rexahn Investigative Site
    • Washington
      • Bellevue, Washington, United States, 98007
        • Rexahn Investigative Site (2)
      • Bellevue, Washington, United States, 98007
        • Rexahn Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • Serdaxin®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS)at week 9
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rexahn Pharmaceuticals, Inc.

Investigators

  • Study Director: Christine Peterson, Ph.D, Rexahn Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

January 6, 2011

First Submitted That Met QC Criteria

January 6, 2011

First Posted (Estimate)

January 10, 2011

Study Record Updates

Last Update Posted (Estimate)

November 19, 2013

Last Update Submitted That Met QC Criteria

November 18, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010MDD01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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