A 12-Week, Placebo Controlled Trial of Ziprasidone as Monotherapy for Major Depressive Disorder
Status:
Completed
Trial end date:
2010-06-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 2
Details
Lead Sponsor:
Massachusetts General Hospital
Collaborators:
Cambridge Health Alliance Cedars-Sinai Medical Center Psychiatric Medicine Associates, L.L.C. University of Connecticut Vanderbilt University Vanderbilt University Medical Center