Status:
COMPLETED
Effect of Ziprasidone on Glucose & Plasma Lipids in Diabetes (II) and Schizophrenia or Schizoaffective Disorder
Lead Sponsor:
Manhattan Psychiatric Center
Collaborating Sponsors:
Pfizer
Conditions:
Schizophrenia
Schizoaffective Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
Brief Summary
The aim of the protocol is to study the effects of 320 mg/day of ziprasidone (Geodon) on glucose and lipid metabolism of patients with both Diabetes Type II (DM) and schizophrenia or schizoaffective d...
Detailed Description
Inpatients with DSM IV diagnosis of schizophrenia or schizoaffective disorder and DM II will be enrolled after giving informed consent. Participants may stay on their original ward at MPC, if their cl...
Eligibility Criteria
Inclusion
- Aged 18 to 65 years
- DSM IV diagnosis of schizophrenia (all subtypes) or schizoaffective disorder
- Diabetes Mellitus type II treated with oral antidiabetic drugs or insulin
- Stable dose of antipsychotic regimen for previous one month.
- Stable dose of antidepressant regimen for previous one month.
- Stable dose of adjunctive mood stabilizer and/or anticholinergic regimen for previous 1 month
- Signed informed consent
- Absence of significant cardiovascular pathology as demonstrated by EKG (QTc \< 450 millisec)
- Absence of severe medical conditions (except for DM) requiring frequent changes in medication.
Exclusion
- DSM IV diagnosis other than Schizophrenia or Schizoaffective disorder
- Unstable epilepsy
- Acute, unstable or significant medical condition
- Suicidal or physically violent behavioral episodes in the previous month
- Current DSM IV diagnosis of substance or alcohol abuse with positive urine toxicology in the past two weeks.
- Liver enzyme test values ≥ three times upper normal limit for AST, ALT, GGT, and Alkaline Phosphatase; ≥ two times upper limit for LDH.
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT00395031
Start Date
September 1 2003
End Date
January 1 2010
Last Update
July 29 2011
Active Locations (1)
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1
Manhattan Psychiatric Center
New York, New York, United States, 10035