Status:
COMPLETED
Predictors of Response to Augmentation With Ziprasidone (Geodon®) in Major Depressive Disorder
Lead Sponsor:
Tufts Medical Center
Collaborating Sponsors:
Duke University
University of South Carolina
Conditions:
Depression
Bipolar Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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 depressi...
Detailed Description
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-pla...
Eligibility Criteria
Inclusion
- Age 18-70 years.
- If female, nonpregnant/nonlactating
- If a sexually active female of reproductive potential, must be using adequate contraception (i.e., oral contraceptives, barrier protection, or prior tubal ligation)
- Currently meets DSM-IV criteria for a major depressive episode, non-psychotic.
- Having at least 3 of the following criteria listed for predictors of depressive response to neuroleptics: 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). Inadequate response to antidepressants is identified as follows: having a score of ≥14 on the 17-item HAMD or a CGI-S score of ≥ 3 after a retrospective confirmation of an adequate trial of a single antidepressant (defined as a ≥ 6-week trial of acceptable therapeutic dose \[≥ 40 mg of fluoxetine, paroxetine or citalopram, 20 mg of escitalopram, 60 mg of duloxetine, 37.5 mg of paroxetine CR, 150 mg of sertraline, 100 mg of fluvoxamine, 225 mg of venlafaxine XR, 30 mg of mirtazapine, 300 mg of bupropion, 75 mg of nortriptyline, 20 mg of protriptyline, 100 mg of amitriptyline or imipramine)
Exclusion
- Bipolar depression
- Sensitivity to or failure to respond to ziprasidone by history or ziprasidone use in previous 3 months
- Active substance abuse or dependence in the previous 3 month
- Psychotic disorders
- Serious suicidality as evidenced by score of 3 or greater on suicide item of MADRS
- Medically unstable as judged by study investigators
- Lack of capacity to provide informed, written, consent to investigators
- Previous diagnosed cardiac arrhythmias
Key Trial Info
Start Date :
February 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT01168674
Start Date
February 1 2010
End Date
December 1 2011
Last Update
February 24 2017
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