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

September 12, 2008 updated by: Genomas, Inc
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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Connecticut
      • Hartford, Connecticut, United States, 06106
        • Recruiting
        • Hartford Hospital Institute of Living
        • Contact:
        • Contact:
        • Principal Investigator:
          • John W Goethe, MD
    • Kentucky
      • Lexington, Kentucky, United States, 40508
        • Recruiting
        • University of Kentucky
        • Contact:
        • Principal Investigator:
          • Jose de Leon, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 59 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients treated for psychoses

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
A
Patients receiving olanzapine
B
patients receiving risperidone
C
Patients receiving quetiapine
D
Patients receiving aripiprazole
E
patients receiving ziprasidone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
after treatment with antipsychotic medication(s) for => 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genomas, Inc

Collaborators

University of Kentucky
Hartford Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (ANTICIPATED)

December 1, 2009

Study Completion (ANTICIPATED)

December 1, 2009

Study Registration Dates

First Submitted

September 12, 2008

First Submitted That Met QC Criteria

September 12, 2008

First Posted (ESTIMATE)

September 16, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

September 16, 2008

Last Update Submitted That Met QC Criteria

September 12, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R44MH073291 (NIH)
  • 50R44 MH073291-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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