Rosiglitazone for Clozapine Induced Glucose Metabolism Impairment
Schizophrenia
About this trial
This is an interventional prevention trial for Schizophrenia focused on measuring Schizophrenia, Glucose Metabolism, Insulin Resistance
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)
Sites / Locations
- Massachusetts General Hospital Schizophrenia Program
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
rosiglitazone
placebo
rosiglitazone 4mg/day
matched placebo for 4mg rosiglitazone