Efficacy Study of RX-10100 to Treat Major Depressive Disorder (MDD)
NCT00839176 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 118
Last updated 2013-11-19
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.
Conditions
- Major Depressive Disorder (MDD)
Interventions
- DRUG
-
RX-10100
Extended-release tablet, 5\~15mg, twice day (morning \& evening) at least 30 min before meal, 8 weeks
Sponsors & Collaborators
-
Rexahn Pharmaceuticals, Inc.
lead INDUSTRY
Principal Investigators
-
Christine Peterson, PhD · Rexahn Pharmaceuticals, Inc.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-01-31
- Primary Completion
- 2009-09-30
- Completion
- 2009-10-31
Countries
- United States
Study Locations
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