Anticonvulsant Mood Stabilizers, Antipsychotic Drugs and the Insulin Resistance Syndrome



Status:Completed
Conditions:Schizophrenia, Psychiatric, Psychiatric, Endocrine, Endocrine, Bipolar Disorder
Therapuetic Areas:Endocrinology, Psychiatry / Psychology
Healthy:No
Age Range:18 - 65
Updated:10/14/2017
Start Date:January 2006
End Date:December 2008

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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.


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:
We found this trial at
1
site
Nashville, Tennessee 37212
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from
Nashville, TN
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