Anticonvulsant Mood Stabilizers, Antipsychotic Drugs and the Insulin Resistance Syndrome
This study has been completed.
Sponsor:
Vanderbilt University
Collaborators:
National Alliance for Research on Schizophrenia and Depression
Pfizer
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00288366
First received: February 6, 2006
Last updated: January 23, 2009
Last verified: January 2009
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Schizophrenia Schizoaffective Disorder Bipolar Disorder |
Drug: ziprasidone vs. aripiprazole Drug: aripiprazole vs. ziprasidone |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Anticonvulsant Mood Stabilizers, Antipsychotic Drugs and the Insulin Resistance Syndrome |
Resource links provided by NLM:
Drug Information available for:
Ziprasidone hydrochloride
Aripiprazole
Ziprasidone
Ziprasidone mesylate
U.S. FDA Resources
Further study details as provided by Vanderbilt University:
Primary Outcome Measures:
- change in TG/HDL ratio after medication switch [ Time Frame: twelve months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- change in cognition after medication switch [ Time Frame: twelve months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 250 |
| Study Start Date: | January 2006 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
aripiprazole (Abilify)
|
Drug: ziprasidone vs. aripiprazole
ziprasidone vs. aripiprazole dosed according to package insert
Drug: aripiprazole vs. ziprasidone
aripiprazole vs. ziprasidone dosed according to package insert
|
|
Active Comparator: 2
ziprasidone (Geodon)
|
Drug: aripiprazole vs. ziprasidone
aripiprazole vs. ziprasidone dosed according to package insert
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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:
-
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00288366
Locations
| United States, Tennessee | |
| Psychiatric Hospital at Vanderbilt | |
| Nashville, Tennessee, United States, 37212 | |
Sponsors and Collaborators
Vanderbilt University
National Alliance for Research on Schizophrenia and Depression
Pfizer
Investigators
| Principal Investigator: | Yuejin Chen, M.D. | Vanderbilt University |
More Information
No publications provided
| Responsible Party: | Herbert Meltzer, M.D., Vanderbilt University Medical Center |
| ClinicalTrials.gov Identifier: | NCT00288366 History of Changes |
| Other Study ID Numbers: | 050942, NARSAD |
| Study First Received: | February 6, 2006 |
| Last Updated: | January 23, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Vanderbilt University:
|
schizophrenia schizoaffective disorder bipolar disorder metabolic syndrome |
Additional relevant MeSH terms:
|
Bipolar Disorder Insulin Resistance Metabolic Syndrome X Psychotic Disorders Schizophrenia Affective Disorders, Psychotic Mood Disorders Mental Disorders Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases Schizophrenia and Disorders with Psychotic Features Anticonvulsants Antipsychotic Agents Aripiprazole |
Ziprasidone Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Psychotropic Drugs Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Dopamine Antagonists Dopamine Agents |
ClinicalTrials.gov processed this record on May 22, 2013