Depression Clinical Trial
Official title:
Predictors of Response to Augmentation With Ziprasidone (Geodon®) in Major Depressive Disorder : A 13-week, Double-Blind, Placebo-Controlled, Cross-Over Trial
The primary outcome of this study is to determine if predictors of response can select a
population of patients with MDD that is effectively treatable by augmentation with
ziprasidone.
Major depressive disorder (MDD) is a broad category, including many forms of depressive
illness, including those with only a single major depressive episode, those with episodic
recurrence with intervening well states, those with chronic depressive/anxious states
without intervening euthymia, and those with manic symptoms that do not meet threshold
definitions of full mania/hypomania.
In this heterogenous, large diagnostic definition, important groups of patients do not
appear to respond well to antidepressants, and, conversely, based on observational studies,
may respond well to neuroleptics. These predictors of response have begun to be identified
and may serve to better design studies of neuroleptics in depressive illnesses.
Among these predictors of response in MDD are clinical features that are more similar to
bipolar illness than unipolar depression. These include a family history of bipolar
disorder, antidepressant-induced mania, highly recurrent depressive episodes (>5), atypical
depression, early age of onset of depression (< age 20), failure to respond to
antidepressants, and antidepressant tolerance (initial response followed by later loss of
response).
The investigators propose to use these predictors to pick out patients that are more likely
to respond to Geodon for MDD. This will be the first RCT of these predictors of depressive
response applied to neuroleptics.
This will be a three-site, block randomized (1:1 ratio) double-blind, placebo-controlled
prospective cross-over study with 50 subjects. Patients will be randomized to receiving
ziprasidone-washout-placebo or placebo- washout-ziprasidone for 13-weeks.
Primary and Secondary and safety outcomes: The primary outcome measure will be change from
baseline Montgomery-Asberg Depression Rating Scale (MADRS) score to end of treatment. Safety
outcomes will be determined by spontaneously reported adverse events on the case report
form.
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