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

Completed · Phase 2/Phase 3

Conditions studied: Schizophrenia, Schizoaffective Disorder

In brief

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.

Key facts

Study ID

NCT00395031

Run by

Manhattan Psychiatric Center

People needed

57

Starts

2003-09-01

Expected to finish

2010-01-01

Last updated by the study team

2011-07-29

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Manhattan Psychiatric Center — New York, New York, United States

Full record on ClinicalTrials.gov

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