Anticonvulsant Mood Stabilizers, Antipsychotic Drugs and the Insulin Resistance Syndrome

Schizophrenia Clinical Trial

Official title:

Anticonvulsant Mood Stabilizers, Antipsychotic Drugs and the Insulin Resistance Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00288366
• Other study ID #: 050942
• Secondary ID: NARSAD
• Status: Completed
• Phase: N/A
• Start date: January 2006
• Est. completion date: December 2008

Study information

• Verified date: July 2019
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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:

-

Related Conditions & MeSH terms

• Bipolar Disorder
• Disease
• Insulin Resistance
• Metabolic Syndrome
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Drug:
• ziprasidone vs. aripiprazole
ziprasidone vs. aripiprazole dosed according to package insert
• aripiprazole vs. ziprasidone
aripiprazole vs. ziprasidone dosed according to package insert

Locations

Country	Name	City	State
United States	Psychiatric Hospital at Vanderbilt	Nashville	Tennessee

Sponsors (3)

Lead Sponsor	Collaborator
Northwestern University	National Alliance for Research on Schizophrenia and Depression, Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HDL Ratio	change in HDL ratio after medication switch	24 weeks from Baseline