Predictors of Response to Augmentation With Ziprasidone (Geodon®) in Major Depressive Disorder
Status:
Completed
Trial end date:
2011-12-01
Target enrollment:
Participant gender:
Summary
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.