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)

Rexahn Pharmaceuticals, Inc.0 sites118 target enrollmentJanuary 2009

ConditionsMajor Depressive Disorder (MDD)

InterventionsRX-10100

DrugsRX-10100

Overview

Phase: Phase 2
Intervention: RX-10100
Conditions: Major Depressive Disorder (MDD)
Sponsor: Rexahn Pharmaceuticals, Inc.
Enrollment: 118
Primary Endpoint: Change from baseline at 8 weeks on the Montgomery-Asberg Depression Rating Scale (MADRS)
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2009

End Date

October 2009

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Rexahn Pharmaceuticals, Inc.

Responsible Party

Sponsor

Eligibility 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