Anticonvulsant Mood Stabilizers, Antipsychotic Drugs and the Insulin Resistance Syndrome

This study has been completed.
Sponsor:
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 26, 2014