DNA Diagnostics for Minimizing Metabolic Side-Effects of Antipsychotics

Psychoses Clinical Trial

— DIMS  

Official title:

DNA Diagnostics for Minimizing Metabolic Side-Effects of Antipsychotics

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00752960
• Other study ID #: R44MH073291
• Secondary ID: 50R44 MH073291-0
• Status: Recruiting
• Phase: N/A
• First received: September 12, 2008
• Last updated: September 12, 2008
• Start date: January 2007
• Est. completion date: December 2009

Study information

• Verified date: September 2008
• Source: Genomas, Inc
• Contact: Steven Woolley, PhD
• Phone: 860-545-7329
• Email: swoolle[@]harthosp.org
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 59 Years

Eligibility

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:

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Psychoses

Locations

Country	Name	City	State
United States	Hartford Hospital Institute of Living	Hartford	Connecticut
United States	University of Kentucky	Lexington	Kentucky

Sponsors (3)

Lead Sponsor	Collaborator
Genomas, Inc	Hartford Hospital, University of Kentucky

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes

External Links

•   Institute of Living, Hartford Hospital, Hartford, CT
•   University of Kentucky Department of Psychiatry