Major Depressive Disorder Clinical Trial
Official title:
A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Sequential Trial of Ziprasidone as Monotherapy for Major Depressive Disorder
This is a study on the effectiveness, tolerability and safety of oral ziprasidone as
monotherapy in patients with major depressive disorder (MDD). Outpatients suffering from MDD
will be treated with either ziprasidone or placebo for 12 weeks.
Hypothesis: There will be a statistically significant difference in the magnitude of
response, as measured by a decrease in baseline 17-item Hamilton Depression Rating Scale
(HAM-D-17) scores, between the two treatment groups; the reduction in HAM-D-17 scores will
be greater in the ziprasidone monotherapy group than in the placebo group.
Exploratory hypothesis 1: There will be a statistically significant difference in the
percentage of responders in the two treatment groups; response rates will be significantly
higher for the ziprasidone monotherapy compared to the placebo group.
Exploratory hypothesis 2: The change in 6-VAS-D scores during the trial will be highly
correlated to the change in HAM-D-17 and QIDS-SR during the trial.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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