DNA Diagnostics for Minimizing Metabolic Side-Effects of Antipsychotics

• Conditions: Psychoses

• Registration Number: NCT00752960
• Lead Sponsor: Genomas, Inc

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.

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 Timeline

• Study Start: 2007-01
• Status Verified: 2008-09
• Study First Submitted: 2008-09-12
• Study First Submitted QC: 2008-09-12
• Last Update Submitted: 2008-09-12
• Study First Posted: 2008-09-16
• Last Update Posted: 2008-09-16
• Primary Completion: 2009-12
• Study Completion: 2009-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States

Hartford Hospital Institute of Living; 🇺🇸 Hartford, Connecticut, United States