DNA Diagnostics for Minimizing Metabolic Side-Effects of Antipsychotics (DIMS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by Genomas, Inc.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Hartford Hospital
University of Kentucky
Information provided by:
Genomas, Inc
ClinicalTrials.gov Identifier:
NCT00752960
First received: September 12, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted

September 12, 2008
September 12, 2008
January 2007
December 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
DNA Diagnostics for Minimizing Metabolic Side-Effects of Antipsychotics
DNA Diagnostics for Minimizing Metabolic Side-Effects of Antipsychotics

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.

Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Retention:   Samples With DNA
Description:

DNA extracted from whole blood

Non-Probability Sample

Patients treated for psychoses

Psychoses
Not Provided
  • A
    Patients receiving olanzapine
  • B
    patients receiving risperidone
  • C
    Patients receiving quetiapine
  • D
    Patients receiving aripiprazole
  • E
    patients receiving ziprasidone

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
December 2009
December 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 59 Years
No
Contact: Steven Woolley, PhD 860-545-7329 swoolle@harthosp.org
United States
 
NCT00752960
R44MH073291, 50R44 MH073291-03
No
Gualberto Rauno, MD, PhD/President, Genomas, Inc.
Genomas, Inc
  • Hartford Hospital
  • University of Kentucky
Principal Investigator: Gualberto Ruano, MD, PhD Genomas, Inc
Genomas, Inc
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP