Recruiting

DNA DiagnosticsDNA Diagnostics for Minimizing Metabolic Side-Effects of Antipsychotics

Sponsor:

Genomas, Inc

Code:

NCT00752960

Conditions

Psychoses

Eligibility Criteria

Sex: All

Age: 18 - 59

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

Psychoses

Study ID

NCT00752960

Start date

Jan, 2007

Status verified date

Sep, 2008

Completion date

Dec, 2009

Anticipated

Primary completion date

Dec, 2009

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 59

Healthy Volunteers: Not accepted

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 Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients receiving olanzapine

patients receiving risperidone

Patients receiving quetiapine

Patients receiving aripiprazole

patients receiving ziprasidone

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 ]

Central Contacts and Locations

Central contacts

Steven Woolley, PhD

860-545-7329 swoolle@harthosp.org

Locations

Hartford Hospital Institute of Living

Recruiting

Hartford, Connecticut, United States, 06106

Contacts

Steven Woolley, PhD

860-545-7329 Swoolle@harthosp.org

John D. Goethe, MD

860-545-7118 jgoethe@harthosp.org

Principal Investigator:

John W Goethe, MD

University of Kentucky

Recruiting

Lexington, Kentucky, United States, 40508

Contacts

Jose de Leon, MD

859-246-7563 jdeleon@uky.edu

Principal Investigator:

Jose de Leon, MD

More Information

Sponsor

Genomas, Inc

Last update posted

Sep 16, 2008

Last verified

Sep, 2008

Keywords

single nucleotide polymorphism, SNP, aripiprazole, olanzapine, quetiapine, risperidone, ziprasidone, metabolic syndrome

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Genomas, Inc on 2008-09-16.