Major Depressive Disorder Clinical Trial
Official title:
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of DOV 21,947 in Patients With Major Depressive Disorder
The primary objectives of this placebo-controlled trial are to evaluate effectiveness and safety of DOV 21,947 at two oral dose levels.
DOV 21,947 is an investigational drug that is being developed for the treatment of
depression. The purpose of this study is to evaluate the safety and effectiveness of a
flexible dosing schedule of DOV 21,947 (25 mg twice daily for two weeks, then 50 mg twice
daily for four weeks as compared to placebo) in the treatment of major depressive disorder.
Information about any side effects that may occur will also be collected.
The efficacy evaluation will be based on the change in the total MADRS and HAMD-17 scores
from randomization to week 9 .The secondary objective is to determine if DOV 21,947 improves
the quality of life for patients with MDD as compared to placebo
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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