Anticonvulsant Mood Stabilizers, Antipsychotic Drugs and the Insulin Resistance Syndrome

Northwestern University

Status: Completed

Conditions: Schizophrenia; Bipolar Disorder; Schizoaffective Disorder

Treatments: Drug: aripiprazole vs. ziprasidone; Drug: ziprasidone vs. aripiprazole

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00288366

050942

NARSAD

Details and patient eligibility

About

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.

Enrollment: 49 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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:

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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49 participants in 2 patient groups

1

Active Comparator group

Description:

aripiprazole (Abilify)

Treatment:

Drug: ziprasidone vs. aripiprazole

Drug: aripiprazole vs. ziprasidone

2

Active Comparator group

Description:

ziprasidone (Geodon)

Treatment:

Drug: aripiprazole vs. ziprasidone