Pioglitazone as a Treatment for Lipid and Glucose Abnormalities In Patients With Schizophrenia

Completed · Phase 4 · Has a placebo group

Conditions studied: Diabetes, Schizophrenia, Insulin Resistance, Cognitive Impairment

In brief

This is a study with an approved drug for treating type 2 diabetes, for its effects on treating glucose and lipid abnormalities in patients being treated with first or second-generation antipsychotics, and comparison of effects of this drug with another treatment lifestyle modification. Patients who meet inclusion criteria will be treated with pioglitazone for 12 weeks. They will be evaluated for fasting glucose and lipids, glucose-tolerance tests, and neurocognitive battery and tests of verbal memory at baseline and during treatment with pioglitazone.

Key facts

Study ID

NCT00231894

Run by

Nathan Kline Institute for Psychiatric Research

People needed

56

Starts

2005-05-01

Expected to finish

2010-01-01

Last updated by the study team

2017-12-11

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients will be males or females, 18-70 yrs of age, with a diagnosis of schizophrenia or schizoaffective disorder, and currently being treated with olanzapine or clozapine.
• Patients will have evidence of:
• glucose levels indicating at least impaired fasting glucose: fasting glucose 100 mg/dL or 2 hr glucose tolerance test 140 mg/dL, or current treatment with oral antidiabetic drugs with history of hyperglycemia;
• Triglyceride levels > 120 mg/dL and/or HDL levels < 40 mg/dL

You may not qualify if…

• Diabetes mellitus, type 1
• Recent diabetic ketoacidosis;
• Patients not currently treated with oral antidiabetic drugs but fasting is glucose 140 mg/dL [WHO criteria] on repeat testing in last three months, or random blood glucose >200 mg/dL plus 2 hr glucose on GTT >200 mg/dL; (these patients may need more immediate treatment with antidiabetic drugs and it is less certain if weight-lifestyle treatment would be effective in treating such high glucose levels);
• Patients with active liver disease with clinical abnormalities which need current treatment, or liver enzymes (Alt) 3 times upper limit for normal values in chart records in last year, or patients who are recorded as positive for hepatitis C;
• Congestive heart failure (Class III or IV cardiac status) or history of MI in medical record (because pioglitazone can increase blood volume slightly);
• Hematocrit greater than 10% below normal (hematocrit may be decreased 2 to 4% due to increased plasma volume);
• Female patients on current oral contraceptives (because pioglitazone may interfere with effects of some oral contraceptives);
• Patients taking ketoconazole,
• Patients who have started on atorvastatin or gemfibrozil in the past 2 months or have had a dose increase in atorvastatin in the last month (since these drugs can also lower triglycerides and raise HDL, recent start of therapy with these drugs could be a confound).
• Patients are not concomitantly treated with aripiprazole or ziprasidone.

Where it is running

• Nathan Kline Institute for Psychiatric Research — New York, New York, United States

Full record on ClinicalTrials.gov

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