Status:
COMPLETED
Ziprasidone for Clozapine- or Olanzapine-Associated Diabetes Mellitus
Lead Sponsor:
North Suffolk Mental Health Association
Collaborating Sponsors:
Pfizer
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
This study is a six-week, open label trial of the novel antipsychotic agent, ziprasidone, added to a stable dose of clozapine or olanzapine in 40 diabetes mellitus patients, patients with an impaired ...
Detailed Description
Specific Aims: This study is a six-week, open label trial of the novel antipsychotic agent, ziprasidone, added to a stable dose of clozapine or olanzapine in 40 diabetes mellitus patients, patients w...
Eligibility Criteria
Inclusion
- Diagnosis of Schizophrenia, any subtype or schizoaffective disorder
- Ages 18-65 years
- Capable of providing informed consent
- Antipsychotic Agents -associated diabetes mellitus, impaired fasting glucose or insulin resistance
- Stable dose of clozapine or olanzapine for at least 1 month
- Optimal dose of clozapine or olanzapine, or a maximal dose if limited by significant side effects
Exclusion
- Serious medical or neurological illness (unstable cardiac disease including recent myocardial infarction or heart failure, seizure disorder, malignancy, liver or renal impairment, etc.)
- Current substance abuse
- Pregnancy, nursing, or unwilling to use appropriate birth control measures during participation if female and fertile
- History of serious blood dyscrasia requiring discontinuation of clozapine
- Serious suicidal or homicidal risk within the past six months
- History of diabetes mellitus prior to treatment with clozapine or olanzapine
- H/o prolongation of QTc interval (\>450) on EKG or clinically significant EKG abnormalities.
- Treatment with medications that significantly prolong QTc interval such as dofetilde, sotalol, quinidine, class Ia and III antiarrhythmics, mesoridazine, thioridazine, chlorpromazine, droperidol, pimozide, sparfloxacin, gatifloxacin, moxifloxacine, halofantrine, mefloquine, pentamidine, arsenic trioxide, levomethadyul acetate, dolasetron myselate, probucol, or tacrolimus.
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00351000
Start Date
January 1 2005
End Date
March 1 2007
Last Update
January 13 2017
Active Locations (1)
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1
Freedom Trail Clinic
Boston, Massachusetts, United States, 02114