Rosiglitazone for Clozapine Induced Glucose Metabolism Impairment
NCT ID: NCT00337350
Last Updated: 2015-05-08
Study Results
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE4
Total Enrollment
20 participants
Study Classification
INTERVENTIONAL
Study Start Date
2003-09-30
Study Completion Date
2011-01-31
Brief Summary
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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 test. Bergman's Minimal Model analysis with frequent sampled intravenous glucose tolerance test (FSIVGTT) provides a sensitive and reliable method to measure glucose effectiveness, insulin secretion and insulin sensitivity. The MINMOD determines the relationship between insulin sensitivity, insulin secretion and the degree of obesity and can be used to study drug effects upon these variables.
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Detailed Description
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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 intravenous glucose tolerance test (FSIVGTT) for examination of glucose metabolism. Rosiglitazone, used for the treatment of type 2 diabetes, improves glycemic control by improving insulin sensitivity in target tissues while increase glucose uptake and improving signaling between insulin and glucose transporters. The MINMOD determines the relationship between insulin sensitivity, insulin secretion and the degree of obesity and can be used to study drug effects upon these variables. The computer program estimates glucose effectiveness (SG), insulin sensitivity (SI), and the acute insulin response to glucose (AIRG) from glucose and insulin values measured during the FSIVGTT.
The site for subject enrollment, clinical assessment and collection of blood samples at weeks 2, 4, and 6 will be at the Freedom Trail Clinic of the Erich Lindemann Mental Health Center. The FSIVGTT and blood samples at baseline and week 8 will be conducted at the Mallinckrodt General Clinical Research Center at Massachusetts General Hospital. Subjects will include 50 clozapine treated patients with the diagnosis of schizophrenia or schizoaffective disorder. Subjects will be matched according to baseline fasting glucose.
Subjects will be maintained on their pre-study medication. During the baseline assessment, a member of the research team will conduct the PANSS (Positive and Negative Symptom Subscale) and HAM-D (Hamilton Rating Scale for Depression) which will be repeated at weeks 4 and 8 to determine baseline and subsequent changes in psychopathology. The neuropsychological battery will be administered at baseline and week 8 and will consist of: North America Adult Reading Test, Trail Making, Degraded Stimulus Continuous Performance Test, California Verbal Learning Test, Faces and Family Picture subtests from WMS-III, Wisconsin Card Sorting Test, Letter and Category Fluency, Letter-Number Sequencing, and Grooved Peg Board. Baseline medical evaluation will include weight, height, vital signs, AIMS score, a 12-lead EKG and a physical examination.
Subjects will be instructed to eat a diet high in carbohydrates for three days before the FSIVGTT. They are instructed to fast for 12 hours preceding the test. On the morning of the test, subjects will be admitted to the General Clinical Research Center at Massachusetts General Hospital. A nutritional assessment will be performed. Baseline blood samples for fasting glucose, basic chemistry profiles, liver enzymes, complete blood count (cbc), insulin, prolactin, lipid profile, glycohemoglobin, leptin, clozapine serum levels and cortisol will be drawn. Glucose 0.3 g/kg body weight will be infused. Approximately 35 2 cc blood samples will be withdrawn for measurement of glucose and insulin concentration. At minute 20, 0.05 units/kg of insulin will be administered as an intravenous bolus injection.
Following baseline FSIVGTT, subjects will be randomized, double-blind, to either rosiglitazone or placebo. Subjects randomized to receive medication will receive rosiglitazone 4mg po qd for eight weeks or until study end. Subjects will be monitored for symptoms of diabetes at weeks 2, 4, and 8. Subjects will be evaluated at weeks 2, 4, and 8 including measurements of blood pressure, pulse and weight. Adverse events will be monitored at weeks 2, 4, and 8 with the AMDP-5, a survey of side effects and somatic symptoms. The Medical Outcomes Study Short Form-12 (SF-12) will be used to measure general health status and function. The SF-12 will be performed at baseline, weeks 4, and 8 or study end.
A cbc will be performed every two weeks, consistent with the requirements for treatment with clozapine. At week four, a fasting glucose, insulin level, and liver function tests will be performed. At the end of the eighth week, the FSIVGTT will be repeated and blood samples will be obtained for fasting glucose, basic chemistry profiles, liver enzymes, complete blood count (cbc), insulin, prolactin, lipid profile, glycohemoglobin, leptin, clozapine serum levels and cortisol. All other aspects of the subjects care will be treatment as usual.
Potential risks associated with an intravenous line include bruising at the site, bleeding and the risk of infection. During the procedure patient may experience symptoms of low blood glucose including lightheadedness, dizziness, weakness, irritability, sweating, tremor, tachycardia, anxiety, and hunger. The amount of blood drawn with each FSIVGTT is approximately 150 cc. A low risk of anemia exists secondary to the FSIVGTT; anemia has also been a side effect of treatment with rosiglitazone. Treatment with rosiglitazone has been associated with side effects including accidental injury (cuts and abrasions), headache, back pain, anemia, edema, weight gain, decreased white blood cell count, increases in total cholesterol, LDL, and HDL and decreases in free fatty acids. Phlebotomy may produce discomfort, bruising, and rarely, infection. While the clinical assessment may be stressful, the questions contained in the SCID and PANSS do not differ from those asked in routine clinical evaluations.
Potential benefits to the subject include a comprehensive diagnostic re-evaluation, screening blood tests, and estimation of risk of diabetes. The results of the tests will be shared with patients and clinicians and may contribute to medical management by helping the patient's physician in deciding if an intervention is required to reduce the risk of diabetes. An increased understanding of the process by which clozapine induces glucose intolerance and the awareness that diabetes and its complications can be prevented with concomitant treatment with an insulin sensitizer are potential benefits to this population.
The site for subject enrollment, clinical assessment and collection of blood samples at weeks 2, 4, and 6 will be at the Freedom Trail Clinic of the Erich Lindemann Mental Health Center. The FSIVGTT and blood samples at baseline and week 8 will be conducted at the Mallinckrodt General Clinical Research Center at Massachusetts General Hospital. Subjects will include 50 clozapine treated patients with the diagnosis of schizophrenia or schizoaffective disorder. Subjects will be matched according to baseline fasting glucose.
Subjects will be maintained on their pre-study medication. During the baseline assessment, a member of the research team will conduct the PANSS (Positive and Negative Symptom Subscale) and HAM-D (Hamilton Rating Scale for Depression) which will be repeated at weeks 4 and 8 to determine baseline and subsequent changes in psychopathology. The neuropsychological battery will be administered at baseline and week 8 and will consist of: North America Adult Reading Test, Trail Making, Degraded Stimulus Continuous Performance Test, California Verbal Learning Test, Faces and Family Picture subtests from WMS-III, Wisconsin Card Sorting Test, Letter and Category Fluency, Letter-Number Sequencing, and Grooved Peg Board. Baseline medical evaluation will include weight, height, vital signs, AIMS score, a 12-lead EKG and a physical examination.
Subjects will be instructed to eat a diet high in carbohydrates for three days before the FSIVGTT. They are instructed to fast for 12 hours preceding the test. On the morning of the test, subjects will be admitted to the General Clinical Research Center at Massachusetts General Hospital. A nutritional assessment will be performed. Baseline blood samples for fasting glucose, basic chemistry profiles, liver enzymes, complete blood count (cbc), insulin, prolactin, lipid profile, glycohemoglobin, leptin, clozapine serum levels and cortisol will be drawn. Glucose 0.3 g/kg body weight will be infused. Approximately 35 2 cc blood samples will be withdrawn for measurement of glucose and insulin concentration. At minute 20, 0.05 units/kg of insulin will be administered as an intravenous bolus injection.
Following baseline FSIVGTT, subjects will be randomized, double-blind, to either rosiglitazone or placebo. Subjects randomized to receive medication will receive rosiglitazone 4mg po qd for eight weeks or until study end. Subjects will be monitored for symptoms of diabetes at weeks 2, 4, and 8. Subjects will be evaluated at weeks 2, 4, and 8 including measurements of blood pressure, pulse and weight. Adverse events will be monitored at weeks 2, 4, and 8 with the AMDP-5, a survey of side effects and somatic symptoms. The Medical Outcomes Study Short Form-12 (SF-12) will be used to measure general health status and function. The SF-12 will be performed at baseline, weeks 4, and 8 or study end.
A cbc will be performed every two weeks, consistent with the requirements for treatment with clozapine. At week four, a fasting glucose, insulin level, and liver function tests will be performed. At the end of the eighth week, the FSIVGTT will be repeated and blood samples will be obtained for fasting glucose, basic chemistry profiles, liver enzymes, complete blood count (cbc), insulin, prolactin, lipid profile, glycohemoglobin, leptin, clozapine serum levels and cortisol. All other aspects of the subjects care will be treatment as usual.
Potential risks associated with an intravenous line include bruising at the site, bleeding and the risk of infection. During the procedure patient may experience symptoms of low blood glucose including lightheadedness, dizziness, weakness, irritability, sweating, tremor, tachycardia, anxiety, and hunger. The amount of blood drawn with each FSIVGTT is approximately 150 cc. A low risk of anemia exists secondary to the FSIVGTT; anemia has also been a side effect of treatment with rosiglitazone. Treatment with rosiglitazone has been associated with side effects including accidental injury (cuts and abrasions), headache, back pain, anemia, edema, weight gain, decreased white blood cell count, increases in total cholesterol, LDL, and HDL and decreases in free fatty acids. Phlebotomy may produce discomfort, bruising, and rarely, infection. While the clinical assessment may be stressful, the questions contained in the SCID and PANSS do not differ from those asked in routine clinical evaluations.
Potential benefits to the subject include a comprehensive diagnostic re-evaluation, screening blood tests, and estimation of risk of diabetes. The results of the tests will be shared with patients and clinicians and may contribute to medical management by helping the patient's physician in deciding if an intervention is required to reduce the risk of diabetes. An increased understanding of the process by which clozapine induces glucose intolerance and the awareness that diabetes and its complications can be prevented with concomitant treatment with an insulin sensitizer are potential benefits to this population.
Conditions
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Schizophrenia
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
SINGLE_GROUP
Primary Study Purpose
PREVENTION
Blinding Strategy
TRIPLE
Participants
Investigators
Outcome Assessors
Study Groups
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rosiglitazone
rosiglitazone 4mg/day
Group Type
ACTIVE_COMPARATOR
rosiglitazone
Intervention Type
DRUG
Rosiglitazone 4mg, one capsule per day for eight weeks
placebo
matched placebo for 4mg rosiglitazone
Group Type
PLACEBO_COMPARATOR
placebo
Intervention Type
DRUG
matched placebo for rosiglitazone 4mg/day
Interventions
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rosiglitazone
Rosiglitazone 4mg, one capsule per day for eight weeks
Intervention Type
DRUG
placebo
matched placebo for rosiglitazone 4mg/day
Intervention Type
DRUG
Eligibility Criteria
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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)
* 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)
* 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)
Minimum Eligible Age
18 Years
Maximum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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National Alliance for Research on Schizophrenia and Depression
OTHER
Sponsor Role
collaborator
Stanley Medical Research Institute
OTHER
Sponsor Role
collaborator
Massachusetts General Hospital
OTHER
Sponsor Role
lead
Responsible Party
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David C. Henderson
Associate Professor of Psychiatry
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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David C Henderson, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital Schizophrenia Program
Boston, Massachusetts, United States
Site Status
Countries
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United States
References
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AMDISEN A. DRUG-PRODUCED OBESITY. EXPERIENCES WITH CHLORPROMAZINE, PERPHENAZINE AND CLOPENTHIXOL. Dan Med Bull. 1964 Oct;11:182-9. No abstract available.
Reference Type
BACKGROUND
Bergman RN. Lilly lecture 1989. Toward physiological understanding of glucose tolerance. Minimal-model approach. Diabetes. 1989 Dec;38(12):1512-27. doi: 10.2337/diab.38.12.1512.
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BACKGROUND
Cohen S, Chiles J, MacNaughton A. Weight gain associated with clozapine. Am J Psychiatry. 1990 Apr;147(4):503-4. doi: 10.1176/ajp.147.4.503.
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Cosway R, Strachan MW, Dougall A, Frier BM, Deary IJ. Cognitive function and information processing in type 2 diabetes. Diabet Med. 2001 Oct;18(10):803-10. doi: 10.1046/j.1464-5491.2001.00577.x.
Reference Type
BACKGROUND
Dwyer DS, Liu Y, Bradley RJ. Dopamine receptor antagonists modulate glucose uptake in rat pheochromocytoma (PC12) cells. Neurosci Lett. 1999 Oct 29;274(3):151-4. doi: 10.1016/s0304-3940(99)00712-0.
Reference Type
BACKGROUND
Dwyer DS, Pinkofsky HB, Liu Y, Bradley RJ. Antipsychotic drugs affect glucose uptake and the expression of glucose transporters in PC12 cells. Prog Neuropsychopharmacol Biol Psychiatry. 1999 Jan;23(1):69-80. doi: 10.1016/s0278-5846(98)00092-x.
Reference Type
BACKGROUND
Goldstein LE, Sporn J, Brown S, Kim H, Finkelstein J, Gaffey GK, Sachs G, Stern TA. New-onset diabetes mellitus and diabetic ketoacidosis associated with olanzapine treatment. Psychosomatics. 1999 Sep-Oct;40(5):438-43. doi: 10.1016/S0033-3182(99)71210-7. No abstract available.
Reference Type
BACKGROUND
Hagg S, Joelsson L, Mjorndal T, Spigset O, Oja G, Dahlqvist R. Prevalence of diabetes and impaired glucose tolerance in patients treated with clozapine compared with patients treated with conventional depot neuroleptic medications. J Clin Psychiatry. 1998 Jun;59(6):294-9. doi: 10.4088/jcp.v59n0604.
Reference Type
BACKGROUND
HAMILTON M. A rating scale for depression. J Neurol Neurosurg Psychiatry. 1960 Feb;23(1):56-62. doi: 10.1136/jnnp.23.1.56. No abstract available.
Reference Type
BACKGROUND
Henderson DC, Cagliero E, Gray C, Nasrallah RA, Hayden DL, Schoenfeld DA, Goff DC. Clozapine, diabetes mellitus, weight gain, and lipid abnormalities: A five-year naturalistic study. Am J Psychiatry. 2000 Jun;157(6):975-81. doi: 10.1176/appi.ajp.157.6.975.
Reference Type
BACKGROUND
Kay SR, Opler LA, Lindenmayer JP. Reliability and validity of the positive and negative syndrome scale for schizophrenics. Psychiatry Res. 1988 Jan;23(1):99-110. doi: 10.1016/0165-1781(88)90038-8.
Reference Type
BACKGROUND
Khandoudi N, Delerive P, Berrebi-Bertrand I, Buckingham RE, Staels B, Bril A. Rosiglitazone, a peroxisome proliferator-activated receptor-gamma, inhibits the Jun NH(2)-terminal kinase/activating protein 1 pathway and protects the heart from ischemia/reperfusion injury. Diabetes. 2002 May;51(5):1507-14. doi: 10.2337/diabetes.51.5.1507.
Reference Type
BACKGROUND
Lamberti JS, Bellnier T, Schwarzkopf SB. Weight gain among schizophrenic patients treated with clozapine. Am J Psychiatry. 1992 May;149(5):689-90. doi: 10.1176/ajp.149.5.689.
Reference Type
BACKGROUND
Nuechterlein KH, Dawson ME, Gitlin M, Ventura J, Goldstein MJ, Snyder KS, Yee CM, Mintz J. Developmental Processes in Schizophrenic Disorders: longitudinal studies of vulnerability and stress. Schizophr Bull. 1992;18(3):387-425. doi: 10.1093/schbul/18.3.387.
Reference Type
BACKGROUND
Newcomer JW, Haupt DW, Fucetola R, Melson AK, Schweiger JA, Cooper BP, Selke G. Abnormalities in glucose regulation during antipsychotic treatment of schizophrenia. Arch Gen Psychiatry. 2002 Apr;59(4):337-45. doi: 10.1001/archpsyc.59.4.337.
Reference Type
BACKGROUND
Saltiel AR, Olefsky JM. Thiazolidinediones in the treatment of insulin resistance and type II diabetes. Diabetes. 1996 Dec;45(12):1661-9. doi: 10.2337/diab.45.12.1661.
Reference Type
BACKGROUND
Segal DL, Hersen M, Van Hasselt VB. Reliability of the Structured Clinical Interview for DSM-III-R: an evaluative review. Compr Psychiatry. 1994 Jul-Aug;35(4):316-27. doi: 10.1016/0010-440x(94)90025-6.
Reference Type
BACKGROUND
Skre I, Onstad S, Torgersen S, Kringlen E. High interrater reliability for the Structured Clinical Interview for DSM-III-R Axis I (SCID-I). Acta Psychiatr Scand. 1991 Aug;84(2):167-73. doi: 10.1111/j.1600-0447.1991.tb03123.x.
Reference Type
BACKGROUND
Strachan MW, Deary IJ, Ewing FM, Frier BM. Is type II diabetes associated with an increased risk of cognitive dysfunction? A critical review of published studies. Diabetes Care. 1997 Mar;20(3):438-45. doi: 10.2337/diacare.20.3.438.
Reference Type
BACKGROUND
Valdes CT, Elkind-Hirsch KE. Intravenous glucose tolerance test-derived insulin sensitivity changes during the menstrual cycle. J Clin Endocrinol Metab. 1991 Mar;72(3):642-6. doi: 10.1210/jcem-72-3-642.
Reference Type
BACKGROUND
Ventura J, Liberman RP, Green MF, Shaner A, Mintz J. Training and quality assurance with the Structured Clinical Interview for DSM-IV (SCID-I/P). Psychiatry Res. 1998 Jun 15;79(2):163-73. doi: 10.1016/s0165-1781(98)00038-9.
Reference Type
BACKGROUND
Wahlin A, Nilsson E, Fastbom J. Cognitive performance in very old diabetic persons: the impact of semantic structure, preclinical dementia, and impending death. Neuropsychology. 2002 Apr;16(2):208-16.
Reference Type
BACKGROUND
Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.
Reference Type
BACKGROUND
Wirshing DA, Spellberg BJ, Erhart SM, Marder SR, Wirshing WC. Novel antipsychotics and new onset diabetes. Biol Psychiatry. 1998 Oct 15;44(8):778-83. doi: 10.1016/s0006-3223(98)00100-0.
Reference Type
BACKGROUND
Other Identifiers
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2003-P-000014
Identifier Type: -
Identifier Source: org_study_id
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