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

Sponsor

Rexahn Pharmaceuticals, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00839176

Collaborator

(none)

118

Enrollment

Locations

Arms

Duration (Months)

39.3

Patients Per Site

4.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Major Depressive Disorder (MDD)	Drug: RX-10100	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

118 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, 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)

Study Start Date :

Jan 1, 2009

Actual Primary Completion Date :

Sep 1, 2009

Actual Study Completion Date :

Oct 1, 2009

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Change from baseline at 8 weeks on the Montgomery-Asberg Depression Rating Scale (MADRS) [8 weeks]

Secondary Outcome Measures

Changes from baseline on the HAM-D [8 weeks]
Changes from baseline on the QIDS-SR [8 weeks]
CGI-I scale at the end of treatment, [8 weeks]
Side effects during and immediately following the treatment period [8 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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