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| ID | Type | Description | Link |
|---|---|---|---|
| 50R44 MH073291-03 |
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| Name | Class |
|---|---|
| Hartford Hospital | OTHER |
| University of Kentucky | OTHER |
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The purpose of this study is to assess patients treated with the antipsychotics aripiprazole (Abilify®), olanzapine (Zyprexa®), quetiapine (Seroquel®), risperidone (Risperdal®), or ziprasidone (Geodon®) and to identify genetic variations more commonly found in individuals who develop diabetic metabolic signs and symptoms, which include changes in blood lipids, blood glucose, blood pressure, and body weight.
As many as 30% of psychiatric patients experience weight gain, central deposition of fat, dyslipidemia, increased blood glucose and hypertension--diabetic metabolic symptoms--upon treatment with atypical antipsychotic medication. As a result, cardiovascular disease risk is significantly increased.
The long-term goal of this collaborative study is to identify, for each individual atypical antipsychotic (AAP) medication, the gene variations associated with elevated risk of diabetic metabolic symptoms (DiMS). If such genes are identified, in the future genetic testing may help mental health care professionals choose treatment while minimizing the risk of undesirable side effects of antipsychotics. We propose to develop a novel product termed "Physiotype" to deliver personalized information for each patient on the drug specific risks among aripiprazole, olanzapine, quetiapine, risperidone, and ziprasidone. The Physiotype consists of a multi-gene ensemble of single nucleotide polymorphisms (SNPs) that, interpreted with a biomathematical algorithm, may explain most of the inter-individual differences in DiMS among the 5 AAPs. If this study does identify related genes, genetic tests will be developed to provide patients and health care professionals with tools to identify those patients who are at risk of developing adverse metabolic side effects to antipsychotics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Patients receiving olanzapine | ||
| B | patients receiving risperidone | ||
| C | Patients receiving quetiapine | ||
| D | Patients receiving aripiprazole | ||
| E | patients receiving ziprasidone |
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| Measure | Description | Time Frame |
|---|---|---|
| diabetic metabolic symptoms (DiMS): body weight, body mass index, waist circumference, blood pressure, triglycerides, total, LDL, and HDL cholesterol, blood glucose | after treatment with antipsychotic medication(s) for => 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients treated for psychoses
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Steven Woolley, PhD | Contact | 860-545-7329 | swoolle@harthosp.org |
| Name | Affiliation | Role |
|---|---|---|
| Gualberto Ruano, MD, PhD | Genomas, Inc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hartford Hospital Institute of Living | Recruiting | Hartford | Connecticut | 06106 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17487003 | Background | Ruano G, Blair CL, Bower B, Windemuth A, Kocherla M, Aleman Y, Pearlson G, Goethe JW, Schwartz HI. Somatic complications of psychotropic medications in a patient with multiple CYP2 drug metabolism deficiencies. Conn Med. 2007 Apr;71(4):197-200. | |
| 17346932 | Background | de Leon J, Susce MT, Johnson M, Hardin M, Pointer L, Ruano G, Windemuth A, Diaz FJ. A clinical study of the association of antipsychotics with hyperlipidemia. Schizophr Res. 2007 May;92(1-3):95-102. doi: 10.1016/j.schres.2007.01.015. Epub 2007 Mar 8. |
| Label | URL |
|---|---|
| Institute of Living, Hartford Hospital, Hartford, CT | View source |
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| ID | Term |
|---|---|
| D011618 | Psychotic Disorders |
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
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DNA extracted from whole blood
| University of Kentucky | Recruiting | Lexington | Kentucky | 40508 | United States |
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| 17199131 | Background | Ruano G, Goethe JW, Caley C, Woolley S, Holford TR, Kocherla M, Windemuth A, de Leon J. Physiogenomic comparison of weight profiles of olanzapine- and risperidone-treated patients. Mol Psychiatry. 2007 May;12(5):474-82. doi: 10.1038/sj.mp.4001944. Epub 2007 Jan 2. |
| 21851846 | Derived | Windemuth A, de Leon J, Goethe JW, Schwartz HI, Woolley S, Susce M, Kocherla M, Bogaard K, Holford TR, Seip RL, Ruano G. Validation of candidate genes associated with cardiovascular risk factors in psychiatric patients. Prog Neuropsychopharmacol Biol Psychiatry. 2012 Mar 30;36(2):213-9. doi: 10.1016/j.pnpbp.2011.08.001. Epub 2011 Aug 6. |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |