DIMS: DNA Diagnostics for Minimizing Metabolic Side-Effects of Antipsychotics
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| A Patients receiving olanzapine |
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| B patients receiving risperidone |
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| C Patients receiving quetiapine |
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| D Patients receiving aripiprazole |
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| E patients receiving ziprasidone |
Outcome Measures
Primary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
receiving atypical antipsychotic therapy (olanzapine, aripiprazole, quetiapine, risperidone, or ziprasidone) for 3 months
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who have taken >50% of the prescribed dose for the last month.
Exclusion Criteria:
- none
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hartford Hospital Institute of Living | Hartford | Connecticut | United States | 06106 |
| 2 | University of Kentucky | Lexington | Kentucky | United States | 40508 |
Sponsors and Collaborators
- Genomas, Inc
- Hartford Hospital
- University of Kentucky
Investigators
- Principal Investigator: Gualberto Ruano, MD, PhD, Genomas, Inc
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- de Leon J, Susce MT, Johnson M, Hardin M, Pointer L, Ruaño G, Windemuth A, Diaz FJ. A clinical study of the association of antipsychotics with hyperlipidemia. Schizophr Res. 2007 May;92(1-3):95-102. Epub 2007 Mar 8.
- Ruaño 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.
- Ruaño 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. Epub 2007 Jan 2.
- R44MH073291
- 50R44 MH073291-03