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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2008 by Genomas, Inc.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00752960
First Posted: September 16, 2008
Last Update Posted: September 16, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Hartford Hospital
University of Kentucky
Information provided by:
Genomas, Inc
  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

Further study details as provided by Genomas, Inc:

Primary Outcome Measures:
  • 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients treated for psychoses
Criteria

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:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00752960


Contacts
Contact: Steven Woolley, PhD 860-545-7329 swoolle@harthosp.org

Locations
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         
Sponsors and Collaborators
Genomas, Inc
Hartford Hospital
University of Kentucky
Investigators
Principal Investigator: Gualberto Ruano, MD, PhD Genomas, Inc
  More Information

Additional Information:
Publications:
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 ( U.S. NIH Grant/Contract )
50R44 MH073291-03
First Submitted: September 12, 2008
First Posted: September 16, 2008
Last Update Posted: September 16, 2008
Last Verified: September 2008

Keywords provided by Genomas, Inc:
single nucleotide polymorphism, SNP, aripiprazole, olanzapine, quetiapine, risperidone, ziprasidone, metabolic syndrome

Additional relevant MeSH terms:
Antipsychotic Agents
Aripiprazole
Ziprasidone
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Dopamine Antagonists
Dopamine Agents