Ziprasidone for Clozapine- or Olanzapine-Associated Diabetes Mellitus

• Status: Completed
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: All

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 fasting glucose or insulin resistance with schizophrenia or schizoaffective disorder. The first two weeks will be a fixed-dose of ziprasidone 40 mg twice a day. During weeks 2-6, the ziprasidone dose may be increased up to 80 mg twice a day.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: North Suffolk Mental Health Association
• Collaborator: Pfizer
• Treatments: Clozapine; Olanzapine; Ziprasidone

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.