Status:
COMPLETED
Rosiglitazone for Clozapine Induced Glucose Metabolism Impairment
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Alliance for Research on Schizophrenia and Depression
Stanley Medical Research Institute
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
We propose an eight-week, double-blind, placebo-controlled trial of rosiglitazone in schizophrenia subjects treated with clozapine using Bergman's Minimal Model (MINMOD) intravenous glucose tolerance ...
Detailed Description
This study is an eight-week, double-blind, placebo-controlled trial of rosiglitazone in schizophrenia subjects treated with clozapine using Bergman's Minimal Model Analysis (MINMOD) frequent sampled i...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00337350
Start Date
September 1 2003
End Date
January 1 2011
Last Update
May 8 2015
Active Locations (1)
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1
Massachusetts General Hospital Schizophrenia Program
Boston, Massachusetts, United States, 02114