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
  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 ] [ 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
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:

  • none
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
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:
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 23, 2014