DNA Diagnostics for Minimizing Metabolic Side-Effects of Antipsychotics (DIMS)
Recruitment status was Recruiting
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Purpose
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 |
|---|
|
Psychoses |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Retrospective |
| Official Title: | DNA Diagnostics for Minimizing Metabolic Side-Effects of Antipsychotics |
- diabetic metabolic symptoms (DiMS): body weight, body mass index, waist circumference, blood pressure, triglycerides, total, LDL, and HDL cholesterol, blood glucose [ Time Frame: after treatment with antipsychotic medication(s) for => 3 months ] [ Designated as safety issue: Yes ]
Biospecimen Retention: Samples With DNA
DNA extracted from whole blood
| Estimated Enrollment: | 1000 |
| Study Start Date: | January 2007 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
A
Patients receiving olanzapine
|
|
B
patients receiving risperidone
|
|
C
Patients receiving quetiapine
|
|
D
Patients receiving aripiprazole
|
|
E
patients receiving ziprasidone
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 59 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients treated for psychoses
Inclusion Criteria:
- receiving atypical antipsychotic therapy (olanzapine, aripiprazole, quetiapine, risperidone, or ziprasidone) for 3 months
- who have taken >50% of the prescribed dose for the last month.
Exclusion Criteria:
- none
Contacts and Locations| Contact: Steven Woolley, PhD | 860-545-7329 | swoolle@harthosp.org |
| United States, Connecticut | |
| Hartford Hospital Institute of Living | Recruiting |
| Hartford, Connecticut, United States, 06106 | |
| Contact: Steven Woolley, PhD 860-545-7329 Swoolle@harthosp.org | |
| Contact: John D. Goethe, MD 860-545-7118 jgoethe@harthosp.org | |
| Principal Investigator: John W Goethe, MD | |
| United States, Kentucky | |
| University of Kentucky | Recruiting |
| Lexington, Kentucky, United States, 40508 | |
| Contact: Jose de Leon, MD 859-246-7563 jdeleon@uky.edu | |
| Principal Investigator: Jose de Leon, MD | |
| Principal Investigator: | Gualberto Ruano, MD, PhD | Genomas, Inc |
More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Gualberto Rauno, MD, PhD/President, Genomas, Inc. |
| ClinicalTrials.gov Identifier: | NCT00752960 History of Changes |
| Other Study ID Numbers: | R44MH073291, 50R44 MH073291-03 |
| Study First Received: | September 12, 2008 |
| Last Updated: | September 12, 2008 |
| Health Authority: | United States: Federal Government |
Keywords provided by Genomas, Inc:
|
single nucleotide polymorphism, SNP, aripiprazole, olanzapine, quetiapine, risperidone, ziprasidone, metabolic syndrome |
Additional relevant MeSH terms:
|
Mental Disorders Psychotic Disorders Schizophrenia and Disorders with Psychotic Features Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants |
Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Psychotropic Drugs |
ClinicalTrials.gov processed this record on May 19, 2013