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Anticonvulsant Mood Stabilizers, Antipsychotic Drugs and the Insulin Resistance Syndrome

Primary Purpose

Schizophrenia, Schizoaffective Disorder, Bipolar Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ziprasidone vs. aripiprazole
aripiprazole vs. ziprasidone
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia, schizoaffective disorder, bipolar disorder, metabolic syndrome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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: -

Sites / Locations

  • Psychiatric Hospital at Vanderbilt

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

aripiprazole (Abilify)

ziprasidone (Geodon)

Outcomes

Primary Outcome Measures

HDL Ratio
change in HDL ratio after medication switch

Secondary Outcome Measures

Full Information

First Posted
February 6, 2006
Last Updated
July 16, 2019
Sponsor
Northwestern University
Collaborators
National Alliance for Research on Schizophrenia and Depression, Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00288366
Brief Title
Anticonvulsant Mood Stabilizers, Antipsychotic Drugs and the Insulin Resistance Syndrome
Official Title
Anticonvulsant Mood Stabilizers, Antipsychotic Drugs and the Insulin Resistance Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
National Alliance for Research on Schizophrenia and Depression, Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder, Bipolar Disorder
Keywords
schizophrenia, schizoaffective disorder, bipolar disorder, metabolic syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
aripiprazole (Abilify)
Arm Title
2
Arm Type
Active Comparator
Arm Description
ziprasidone (Geodon)
Intervention Type
Drug
Intervention Name(s)
ziprasidone vs. aripiprazole
Intervention Description
ziprasidone vs. aripiprazole dosed according to package insert
Intervention Type
Drug
Intervention Name(s)
aripiprazole vs. ziprasidone
Intervention Description
aripiprazole vs. ziprasidone dosed according to package insert
Primary Outcome Measure Information:
Title
HDL Ratio
Description
change in HDL ratio after medication switch
Time Frame
24 weeks from Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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 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: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuejin Chen, M.D.
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Psychiatric Hospital at Vanderbilt
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States

12. IPD Sharing Statement

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Anticonvulsant Mood Stabilizers, Antipsychotic Drugs and the Insulin Resistance Syndrome

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