Changes in Adiposity and Metabolic Measures During Medication Switches to Aripiprazole from Other Atypical Antipsychotics
Reference Number: 201105434
WHAT IS THE PURPOSE OF THE STUDY?
The overall purpose of this research is to look at how commonly prescribed newer antipsychotic medications affect substances in the body such as glucose and insulin.
WHO IS NEEDED?
Individuals with a diagnosis of schizophrenia and no history of diabetes.
WHAT IS INVOLVED IF I PARTICIPATE?
Duration: Approximately 12 weeks
Tests/Procedures: -Screening visit
-Participants follow a special meal plan for 3 days (food provided) and are then given a glucose tolerance test and DXA scan (to measure body fat and content), and during the tests, you will be asked questions about how you feel.
-After the first testing day, some participants will change from their current antipsychotic medication to a different antipsychotic medication. This will be done under the supervision of their doctor.
Risks: Risks will be discussed in detail at the screening visit.
Benefits: The possible benefits to you and society from this research are:
This study will offer a greater understanding of how newer antipsychotic medications may affect glucose regulation and ways to address the risk of diabetes in patients with schizophrenia. Additionally, this comparison of antipsychotic medication effects may help to inform doctors about the risk of treatment-related changes in glucose regulation associated with certain antipsychotic agents. You will be screened for serious medical conditions that may not show any symptoms, such as high blood pressure and diabetes. Recognition of these conditions plus the careful monitoring received while participating in this study may improve your medical care.
If you are assigned to change your current anti-psychotic medication to aripiprazole, you will receive the newer (atypical) antipsychotic medication at no cost to you during your participation in the study, if needed.
Compensation: You will receive $400 ($20 for the screening session and $180 for the testing session, and $200 for the 12 week testing session) for your participation in this research study. If you should decide to stop your participation before completion, you will receive a portion of the $400 that will be prorated depending on how much of the research study you have already completed.
Transportation (cab) will be provided to and from all study appointments.
WHO IS THE PRINCIPAL INVESTIGATOR (DOCTOR)?
John Newcomer, MD
Associate Professor of Psychiatry
WHERE WILL THE STUDY TAKE PLACE?
Clinical Research Coordinator