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Anticonvulsant Mood Stabilizers, Antipsychotic Drugs and the Insulin Resistance Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00288366
Recruitment Status : Completed
First Posted : February 7, 2006
Results First Posted : August 6, 2019
Last Update Posted : August 6, 2019
Sponsor:
Collaborators:
National Alliance for Research on Schizophrenia and Depression
Pfizer
Information provided by (Responsible Party):
Herbert Meltzer, Vanderbilt 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.


Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Bipolar Disorder Drug: ziprasidone vs. aripiprazole Drug: aripiprazole vs. ziprasidone Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Anticonvulsant Mood Stabilizers, Antipsychotic Drugs and the Insulin Resistance Syndrome
Study Start Date : January 2006
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. HDL Ratio [ Time Frame: 24 weeks from Baseline ]
    change in HDL ratio after medication switch



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00288366


Locations
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United States, Tennessee
Psychiatric Hospital at Vanderbilt
Nashville, Tennessee, United States, 37212
Sponsors and Collaborators
Northwestern University
National Alliance for Research on Schizophrenia and Depression
Pfizer
Investigators
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Principal Investigator: Yuejin Chen, M.D. Vanderbilt University Medical Center
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Responsible Party: Herbert Meltzer, Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00288366    
Other Study ID Numbers: 050942
NARSAD
First Posted: February 7, 2006    Key Record Dates
Results First Posted: August 6, 2019
Last Update Posted: August 6, 2019
Last Verified: July 2019
Keywords provided by Herbert Meltzer, Vanderbilt University:
schizophrenia
schizoaffective disorder
bipolar disorder
metabolic syndrome
Additional relevant MeSH terms:
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Insulin Resistance
Metabolic Syndrome
Disease
Schizophrenia
Bipolar Disorder
Psychotic Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Bipolar and Related Disorders
Aripiprazole
Ziprasidone
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists