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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rexahn Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00839176
First received: February 5, 2009
Last updated: November 18, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Major Depressive Disorder (MDD)
Drug: RX-10100
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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)

Further study details as provided by Rexahn Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Change from baseline at 8 weeks on the Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes from baseline on the HAM-D [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Changes from baseline on the QIDS-SR [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • CGI-I scale at the end of treatment, [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Side effects during and immediately following the treatment period [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 118
Study Start Date: January 2009
Study Completion Date: October 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: 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 Name: Serdaxin

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00839176

Locations
United States, Colorado
Denver, Colorado, United States, 80239
United States, Georgia
Atlanta, Georgia, United States, 30308
United States, Maryland
Rockville, Maryland, United States, 20852
Sponsors and Collaborators
Rexahn Pharmaceuticals, Inc.
Investigators
Study Director: Christine Peterson, PhD Rexahn Pharmaceuticals, Inc.
  More Information

No publications provided by Rexahn Pharmaceuticals, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rexahn Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00839176     History of Changes
Other Study ID Numbers: RX-10100-P2A-002
Study First Received: February 5, 2009
Last Updated: November 18, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Rexahn Pharmaceuticals, Inc.:
Major Depressive Disorder (MDD)
Serdaxin
Rexahn

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

ClinicalTrials.gov processed this record on September 29, 2014