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:
2025-12-24 @ 4:48 PM
Ignite Modification Date:
2025-12-24 @ 4:48 PM
NCT ID:
NCT00337350
Eligibility Criteria:
Inclusion Criteria:
* Male or female
* Age 18-65 years
* Diagnosis of schizophrenia, any subtype, schizoaffective disorder, any subtype or schizophreniform disorder
* Well established compliance with out-patient medications
* Current treatment with clozapine for a minimum of one year
* Evidence of insulin resistance: impaired fasting glucose (glucose ≥100 mg/dl) or hyperinsulinemia (fasting insulin ≥ 15 ng/dl) or a HOMA-IR (homeostasis model assessment for insulin resistance) (fasting glucose X fasting insulin/22.5) ≥2 or a SI (insulin sensitivity index)
Exclusion Criteria:
* Inability to provide informed consent
* Current substance abuse
* Significant medical illness, including congestive heart failure, severe cardiovascular disease, renal disease (serum creatinine \> 1.5), anemia (Hemoglobin \< 11.0 gm/dL) or psychiatrically unstable
* Severe hepatic impairment, active liver disease or increased serum transaminase levels (ALT\>2.0X upper limit of normal) If at any time, ALT increases to 2X ULN, the subject's participation in the study will be terminated.
* Women of child bearing potential who are pregnant, breastfeeding, or who are unwilling or unable to use an effective form of birth control during the entire study
* Treatment with agents that induce weight loss
* History of diabetes mellitus or thyroid disease
* Current treatment with an oral hypoglycemic agent or insulin
* Known hypersensitivity to rosiglitazone or any of its components
* Fasting Glucose \>126 mg/dL11. Treatment with other atypical antipsychotic agents thought to impair glucose metabolism (olanzapine) or low potency conventional agents (thioridazine, chlorpromazine)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00337350
Study Brief:
Protocol Section:
NCT00337350