Effect of Ziprasidone on Glucose & Plasma Lipids in Diabetes (II) and Schizophrenia or Schizoaffective Disorder

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

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 disorder, after switching their antipsychotic medication/s from typical and/or atypical to ziprasidone monotherapy.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Manhattan Psychiatric Center
• Collaborator: Pfizer
• Treatments: Ziprasidone

Criteria

Inclusion Criteria:

1. Aged 18 to 65 years

2. DSM IV diagnosis of schizophrenia (all subtypes) or schizoaffective disorder

3. Diabetes Mellitus type II treated with oral antidiabetic drugs or insulin

4. Stable dose of antipsychotic regimen for previous one month.

5. Stable dose of antidepressant regimen for previous one month.

6. Stable dose of adjunctive mood stabilizer and/or anticholinergic regimen for previous 1 month

7. Signed informed consent

8. Absence of significant cardiovascular pathology as demonstrated by EKG (QTc < 450 millisec)

9. Absence of severe medical conditions (except for DM) requiring frequent changes in medication.

Exclusion Criteria:

1. DSM IV diagnosis other than Schizophrenia or Schizoaffective disorder

2. Unstable epilepsy

3. Acute, unstable or significant medical condition

4. Suicidal or physically violent behavioral episodes in the previous month

5. Current DSM IV diagnosis of substance or alcohol abuse with positive urine toxicology in the past two weeks.

6. Liver enzyme test values ≥ three times upper normal limit for AST, ALT, GGT, and Alkaline Phosphatase; ≥ two times upper limit for LDH.