Anticonvulsant Mood Stabilizers, Antipsychotic Drugs and the Insulin Resistance Syndrome

NCT ID: NCT00288366

Last Updated: 2019-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2008-12-31

Brief Summary

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.

Conditions

Schizophrenia; Schizoaffective Disorder; Bipolar Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

aripiprazole (Abilify)

Group Type: ACTIVE_COMPARATOR

ziprasidone vs. aripiprazole

Intervention Type: DRUG

ziprasidone vs. aripiprazole dosed according to package insert

aripiprazole vs. ziprasidone

Intervention Type: DRUG

aripiprazole vs. ziprasidone dosed according to package insert

2

ziprasidone (Geodon)

Group Type: ACTIVE_COMPARATOR

aripiprazole vs. ziprasidone

Intervention Type: DRUG

aripiprazole vs. ziprasidone dosed according to package insert

Interventions

ziprasidone vs. aripiprazole

ziprasidone vs. aripiprazole dosed according to package insert

Intervention Type: DRUG

aripiprazole vs. ziprasidone

aripiprazole vs. ziprasidone dosed according to package insert

Intervention Type: DRUG

Eligibility 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

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

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Alliance for Research on Schizophrenia and Depression

OTHER

Sponsor Role: collaborator

Pfizer

INDUSTRY

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Herbert Meltzer

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yuejin Chen, M.D.

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

Psychiatric Hospital at Vanderbilt

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

NARSAD

Identifier Type: -

Identifier Source: secondary_id

050942

Identifier Type: -

Identifier Source: org_study_id