Anticonvulsant Mood Stabilizers, Antipsychotic Drugs and the Insulin Resistance Syndrome

The objective of this study is to determine the effect of various mood stabilizers (MS) on the insulin resistance syndrome (IRS; also called the metabolic syndrome) alone and in patients treated with antipsychotic drugs (APDs). Patients will be switched from their current antipsychotic medication to aripiprazole (Abilify) or ziprasidone (Geodon) (unless clinically contraindicated) for comparison with metabolic levels during treatment with the former medication.

The metabolic syndrome is an empirical concept based on extensive evidence that a constellation of 5 metabolic abnormalities, e.g. increased cholesterol, hypertension, low HDL, taken together, predict marked increases in the risk of CVD, stroke and some types of cancer.

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Key information

Conditions

Schizophrenia Bipolar Disorder Bipolar and Related Disorders Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Mental Disorders Metabolic Diseases Metabolic Syndrome Mood Disorders Nutritional and Metabolic Diseases Psychotic Disorders Schizoaffective Disorder Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Psychiatric Hospital at Vanderbilt

Nashville, Tennessee, 37212, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

To be eligible, patients must :

Be male or female, age 18-65
Be diagnosed with schizophrenia, schizoaffective disorder or bipolar disorder with psychotic features according to DSM-IV criteria
Be currently receiving antipsychotic drugs (clozapine, haloperidol, olanzapine, quetiapine, or risperidone) (APDs) alone, mood stabilizer(s) (MS) alone, or a combination of the two
Have a history of compliance with the above medication
Have presumptive IRS as indicated by a TG/HDL ratio > 3.5 on current antipsychotic medication
Be Medicaid eligible or maintain insurance covering requested lab procedures
Be able to provide written informed consent Exclusion criteria

A patient will be considered ineligible if he/she:

Has a diagnosis other than schizophrenia, schizoaffective disorder or bipolar disorder with psychotic features according to DSM-IV criteria.
Has a history of noncompliance with prescribed psychiatric medications
Has a TG/HDL ratio < 3.5 on current medication
Is uninsured or is unable to self-pay potential costs of required lab procedures not covered by insurance.
Is unable to provide written informed consent.
(Females only) Is pregnant, lactating or plans to become pregnant during study participation

Exclusion criteria

Treatment and study plan

ziprasidone vs. aripiprazole

Drug

ziprasidone vs. aripiprazole dosed according to package insert

aripiprazole vs. ziprasidone

Drug

aripiprazole vs. ziprasidone dosed according to package insert

Primary outcomes

HDL Ratio

Time frame: 24 weeks from Baseline

change in HDL ratio after medication switch

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

National Alliance for Research on Schizophrenia and Depression
Pfizer

Registry information

Important dates

Study start: 2006
Primary completion: 2008
Study completion: 2008
First posted: Feb 7, 2006
Registry last updated: Aug 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed