Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 1:34 AM
NCT ID:
NCT00231894
Eligibility Criteria:
Inclusion Criteria:
1. 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.
2. Patients will have evidence of:
1. 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;
2. Triglyceride levels \> 120 mg/dL and/or HDL levels \< 40 mg/dL
Exclusion Criteria:
1. Diabetes mellitus, type 1
2. Recent diabetic ketoacidosis;
3. 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);
4. 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;
5. Congestive heart failure (Class III or IV cardiac status) or history of MI in medical record (because pioglitazone can increase blood volume slightly);
6. Hematocrit greater than 10% below normal (hematocrit may be decreased 2 to 4% due to increased plasma volume);
7. Female patients on current oral contraceptives (because pioglitazone may interfere with effects of some oral contraceptives);
8. Patients taking ketoconazole,
9. 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).
10. Patients are not concomitantly treated with aripiprazole or ziprasidone.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00231894
Study Brief:
Protocol Section:
NCT00231894