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

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
RX-10100
Sponsored by
Rexahn Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring MDD, Depression, Major Depression

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rexahn Investigative Site
  • Rexahn Investigative Site
  • Rexahn Investigative Site
  • Rexahn Investigative Site
  • Rexahn Investigative Site
  • Rexahn Investigative Site
  • Rexahn Investigative Site
  • Rexahn Investigative Site
  • Rexahn Investigative Site
  • Rexahn Investigative Site
  • Rexahn Investigative Site
  • Rexahn Investigative Site
  • Rexahn Investigative Site
  • Rexahn Investigative Site
  • Rexahn Investigative Site
  • Rexahn Investigative Site -2
  • Rexahn Investigative Site
  • Rexahn Investigative Site
  • Rexahn Investigative Site
  • Rexahn Investigative Site
  • Rexahn Investigative Site
  • Rexahn Investigative Site
  • Rexahn Investigative site
  • Rexahn Investigative Site
  • Rexahn Investigative Site
  • Rexahn Investigative Site
  • Rexahn Investigative Site
  • Rexahn Investigative site
  • Rexahn Investigative Site
  • Rexahn Investigative site
  • Rexahn Investigative Site
  • Rexahn Investigative Site
  • Rexahn Investigative Site
  • Rexahn Investigative Site
  • Rexahn Investigative Site
  • Rexahn Investigative site
  • Rexahn Investigative Site
  • Rexahn Investigative Sites
  • Rexahn Investigative Site
  • Rexahn Investigative Site
  • Rexahn Investigative Site
  • Rexahn Investigative Site
  • Rexahn Investigative Site (2)
  • Rexahn Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

RX-10100 high dose

RX-10100 low dose

Placebo

Arm Description

RX-10100 Study drug is to be given orally, in tablet form, twice daily, for 8 weeks

RX-10100 Study drug is to be given orally, in tablet form, twice daily, for 8 weeks

Matching placebo is to be given orally, in tablet form, twice daily, for 8 weeks

Outcomes

Primary Outcome Measures

Change from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS)at week 9

Secondary Outcome Measures

Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) at weeks 3, 5, and 7

Full Information

First Posted
January 6, 2011
Last Updated
November 18, 2013
Sponsor
Rexahn Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01273376
Brief Title
Safety and Efficacy of RX-10100 to Treat Major Depressive Disorder
Acronym
MDD
Official Title
A Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 2 Study of RX-10100 in Subjects With Major Depressive Disorder.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rexahn Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
MDD, Depression, Major Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
314 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RX-10100 high dose
Arm Type
Experimental
Arm Description
RX-10100 Study drug is to be given orally, in tablet form, twice daily, for 8 weeks
Arm Title
RX-10100 low dose
Arm Type
Experimental
Arm Description
RX-10100 Study drug is to be given orally, in tablet form, twice daily, for 8 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo is to be given orally, in tablet form, twice daily, for 8 weeks
Intervention Type
Drug
Intervention Name(s)
RX-10100
Other Intervention Name(s)
Serdaxin®
Intervention Description
Extended-release tablet, taken twice daily for 8 weeks
Primary Outcome Measure Information:
Title
Change from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS)at week 9
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) at weeks 3, 5, and 7
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine Peterson, Ph.D
Organizational Affiliation
Rexahn Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Rexahn Investigative Site
City
Cerritos
State/Province
California
ZIP/Postal Code
90703
Country
United States
Facility Name
Rexahn Investigative Site
City
Escondido
State/Province
California
ZIP/Postal Code
92025
Country
United States
Facility Name
Rexahn Investigative Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
Rexahn Investigative Site
City
National City
State/Province
California
ZIP/Postal Code
91950
Country
United States
Facility Name
Rexahn Investigative Site
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Rexahn Investigative Site
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Rexahn Investigative Site
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Rexahn Investigative Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
82039
Country
United States
Facility Name
Rexahn Investigative Site
City
Brooksville
State/Province
Florida
ZIP/Postal Code
34601
Country
United States
Facility Name
Rexahn Investigative Site
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
Rexahn Investigative Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Rexahn Investigative Site
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33139
Country
United States
Facility Name
Rexahn Investigative Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Rexahn Investigative Site
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Facility Name
Rexahn Investigative Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Rexahn Investigative Site -2
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Rexahn Investigative Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Rexahn Investigative Site
City
Oak Brook
State/Province
Illinois
ZIP/Postal Code
60523
Country
United States
Facility Name
Rexahn Investigative Site
City
Vernon Hills
State/Province
Illinois
ZIP/Postal Code
60061
Country
United States
Facility Name
Rexahn Investigative Site
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42301
Country
United States
Facility Name
Rexahn Investigative Site
City
Novi
State/Province
Michigan
ZIP/Postal Code
48377
Country
United States
Facility Name
Rexahn Investigative Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89146
Country
United States
Facility Name
Rexahn Investigative site
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08002
Country
United States
Facility Name
Rexahn Investigative Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Rexahn Investigative Site
City
Fresh Meadows
State/Province
New York
ZIP/Postal Code
11366
Country
United States
Facility Name
Rexahn Investigative Site
City
New York City
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Rexahn Investigative Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45227
Country
United States
Facility Name
Rexahn Investigative site
City
Garfield Heights
State/Province
Ohio
ZIP/Postal Code
44125
Country
United States
Facility Name
Rexahn Investigative Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Rexahn Investigative site
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Rexahn Investigative Site
City
Media
State/Province
Pennsylvania
ZIP/Postal Code
19063
Country
United States
Facility Name
Rexahn Investigative Site
City
Scranton
State/Province
Pennsylvania
ZIP/Postal Code
18503
Country
United States
Facility Name
Rexahn Investigative Site
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Rexahn Investigative Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Rexahn Investigative Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
Rexahn Investigative site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Rexahn Investigative Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Rexahn Investigative Sites
City
Lake Jackson
State/Province
Texas
ZIP/Postal Code
77566
Country
United States
Facility Name
Rexahn Investigative Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Rexahn Investigative Site
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77381
Country
United States
Facility Name
Rexahn Investigative Site
City
Orem
State/Province
Utah
ZIP/Postal Code
84058
Country
United States
Facility Name
Rexahn Investigative Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23284
Country
United States
Facility Name
Rexahn Investigative Site (2)
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Facility Name
Rexahn Investigative Site
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States

12. IPD Sharing Statement

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

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