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

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

A Double-blinded, Randomized, Placebo-controlled, Dose-Exploring Study of RX-10100 When Given for Eight Consecutive Weeks to Subjects With Major Depression Disorder (MDD)

The primary objective of this Phase IIa trial is to determine the effective dose and treatment period for an upcoming RX-10100 Phase IIb trial in subjects with major depression disorder (MDD). The secondary objectives of this trial are to evaluate the safety and quality of life in subjects with MDD receiving RX-10100 treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

118

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
    • Colorado
      • Denver, Colorado, United States, 80239
    • Georgia
      • Atlanta, Georgia, United States, 30308
    • Maryland
      • Rockville, Maryland, United States, 20852

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Males or females between 18 and 65 years old
  • Diagnosis of MDD using DSM-IV criteria
  • Have a score of 20 or more on the HAM-D-17
  • Have a score of 4 or more on the CGI-S
  • Written informed consent obtained
  • Have a negative serum (P-HCG) pregnancy test at screening (for all women)
  • Female subjects must meet one of the following criteria: (a) Be surgically sterile or (b) Agree that, if sexually active they will use oral contraceptives, double barrier contraception (E.g., condom with spermicide), intrauterine device, or other method approved by the sponsor.

Exclusion Criteria:

  • Have a BMI > 40 or < 18
  • Unstable angina pectoris
  • History of myocardial infarction, stroke, or life-threatening arrhythmia within the prior 6 months
  • Uncontrolled atrial fibrillation/flutter at screening
  • Severe chronic or acute liver disease; history of moderate or severe hepatic impairment
  • Clinically significant chronic hematological disease which may lead to priapism, such as sickle cell anemia and leukemia
  • Bleeding disorder
  • Resting hypotension or hypertension
  • History of malignancy (cancers) within the past 5 years (other than squamous or basal cell skin cancer)
  • NYHA Class III or IV heart failure
  • Substance abuse/dependence within the past 6 months
  • Significant suicidal ideation based on the C-SSRS
  • Other current nondepressive Axis I disorders
  • Depressive episode duration of less than 1 month or greater than 9 months
  • Bipolar disorder
  • Dysthmic disorder
  • Borderline personality disorder
  • Psychotic disorder/current psychotic features
  • Any abnormal findings on the screening ECG judged clinically significant by the Investigator
  • Any medical condition that is not stabilized or is anticipated to require hospitalization within 6 months, in the opinion of the Investigator
  • Any history of cholestatic jaundice or liver cirrhosis
  • Hyper- or hypothyroidism unless the subject has received a stable dose of thyroid medication for at least 3 months prior to the screening visit
  • Women, who are breast-feeding, have been lactating within 3 months prior to screening
  • Concurrent psychotherapy
  • Subjects who have received any other investigational drug (including placebo) within 30 days before Visit 1
  • Use of any treatment for MDD within 7 days of Visit 1 (14 days for fluoxetine) and during the study other than the study medication
  • Use of antidepressants, anxiolytics, or other psychoactive drugs within 14 days of Visit 1 and during the study
  • Concomitant use of antibiotics in the penicillin class (for the reduction of the potential for any additive or synergistic hepatotoxicity)
  • A positive urine drug screen
  • Elevation of AST and/or ALT > 3 times the upper limit of normal (ULN)
  • Diabetic subjects with an HbAlc ≥ 12%
  • Any abnormal screening laboratory values judged clinically significant by the Investigator
  • Previous nonresponse or hypersensitivity to two or more trials of antidepressant medication given in adequate doses and duration for the treatment of symptoms present in the current illness
  • Subjects with known hypersensitivity to any antibiotic in the penicillin class
  • Subjects who are illiterate or unable to understand the questionnaires
  • Subjects who, in the opinion of the investigator, would be non-compliant with the visit schedule of study procedures
  • Subjects who pose potential harm to others

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
Placebo Comparator: Placebo
Placebo (w/o API)
Drug: RX-10100
Extended-release tablet, 5~15mg, twice day (morning & evening) at least 30 min before meal, 8 weeks
Other Names:
  • Serdaxin
Experimental: 2
5mg dose of RX-10100
Drug: RX-10100
Extended-release tablet, 5~15mg, twice day (morning & evening) at least 30 min before meal, 8 weeks
Other Names:
  • Serdaxin
Experimental: 3
10mg dose of RX-10100
Drug: RX-10100
Extended-release tablet, 5~15mg, twice day (morning & evening) at least 30 min before meal, 8 weeks
Other Names:
  • Serdaxin
Experimental: 4
15 mg dose of RX-10100
Drug: RX-10100
Extended-release tablet, 5~15mg, twice day (morning & evening) at least 30 min before meal, 8 weeks
Other Names:
  • Serdaxin

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes from baseline on the HAM-D
Time Frame: 8 weeks
8 weeks
Changes from baseline on the QIDS-SR
Time Frame: 8 weeks
8 weeks
CGI-I scale at the end of treatment,
Time Frame: 8 weeks
8 weeks
Side effects during and immediately following the treatment period
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, PhD, Rexahn Pharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2009

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

February 5, 2009

First Submitted That Met QC Criteria

February 6, 2009

First Posted (Estimate)

February 9, 2009

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

  • RX-10100-P2A-002

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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