Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT00288366
Previous Study | Return to List | Next Study

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

Tracking Information
First Submitted Date  ICMJE February 6, 2006
First Posted Date  ICMJE February 7, 2006
Results First Submitted Date  ICMJE May 24, 2017
Results First Posted Date  ICMJE August 6, 2019
Last Update Posted Date August 6, 2019
Study Start Date  ICMJE January 2006
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 16, 2019)
HDL Ratio [ Time Frame: 24 weeks from Baseline ]
change in HDL ratio after medication switch
Original Primary Outcome Measures  ICMJE
 (submitted: February 6, 2006)
change in TG/HDL ratio after medication switch
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: February 6, 2006)
change in cognition after medication switch
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Anticonvulsant Mood Stabilizers, Antipsychotic Drugs and the Insulin Resistance Syndrome
Official Title  ICMJE Anticonvulsant Mood Stabilizers, Antipsychotic Drugs and the Insulin Resistance Syndrome
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Schizophrenia
  • Schizoaffective Disorder
  • Bipolar Disorder
Intervention  ICMJE
  • Drug: ziprasidone vs. aripiprazole
    ziprasidone vs. aripiprazole dosed according to package insert
  • Drug: aripiprazole vs. ziprasidone
    aripiprazole vs. ziprasidone dosed according to package insert
Study Arms  ICMJE
  • Active Comparator: 1
    aripiprazole (Abilify)
    Interventions:
    • Drug: ziprasidone vs. aripiprazole
    • Drug: aripiprazole vs. ziprasidone
  • Active Comparator: 2
    ziprasidone (Geodon)
    Intervention: Drug: aripiprazole vs. ziprasidone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 16, 2019)
49
Original Enrollment  ICMJE
 (submitted: February 6, 2006)
250
Actual Study Completion Date  ICMJE December 2008
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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:

-

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00288366
Other Study ID Numbers  ICMJE 050942
NARSAD
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Herbert Meltzer, Vanderbilt University
Study Sponsor  ICMJE Northwestern University
Collaborators  ICMJE
  • National Alliance for Research on Schizophrenia and Depression
  • Pfizer
Investigators  ICMJE
Principal Investigator: Yuejin Chen, M.D. Vanderbilt University Medical Center
PRS Account Northwestern University
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP