Anticonvulsant Mood Stabilizers, Antipsychotic Drugs and the Insulin Resistance Syndrome

Not Applicable

Completed

• Conditions: Schizophrenia; Schizoaffective Disorder; Bipolar Disorder
• Interventions: Drug: aripiprazole vs. ziprasidone; Drug: ziprasidone vs. aripiprazole

• Registration Number: NCT00288366
• Lead Sponsor: Northwestern University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2006-02-06
• Study First Submitted QC: 2006-02-06
• Study First Posted: 2006-02-07
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Results First Submitted: 2017-05-24
• Status Verified: 2019-07
• Results First Submitted QC: 2019-07-16
• Last Update Submitted: 2019-07-16
• Results First Posted: 2019-08-06
• Last Update Posted: 2019-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

Not provided

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	aripiprazole vs. ziprasidone	ziprasidone (Geodon)
1	ziprasidone vs. aripiprazole	aripiprazole (Abilify)
1	aripiprazole vs. ziprasidone	aripiprazole (Abilify)

Primary Outcome Measures

Name	Time	Method
HDL Ratio	24 weeks from Baseline	change in HDL ratio after medication switch

Trial Locations

Locations (1)

Psychiatric Hospital at Vanderbilt; 🇺🇸 Nashville, Tennessee, United States