Adjunctive Supplementation of Antioxidants (Vitamins E + C) Plus Omega-3 Fatty Acids

Overview

This research study helps to demonstrate that adding vitamins and fats (nutritional supplements) to a diet will help reduce body weight and improve the lipid profile. This will be done by examining the body weight and chemicals in the blood. The chemicals are the result of the brain using the fat that subjects eat in their diet. Some medications may also change the amount of these chemicals in a person's blood.

Full Title of Study: “Reduction of Body Weight in Olanzapine Treated Schizophrenia Patients by Adjunctive Supplementation of Antioxidants (Vitamins E + C) Plus Omega-3 Fatty Acids”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2006

Detailed Description

To demonstrate that supplementation of antioxidants and omega-3 fatty acids will improve clinical outcome including cognitive performance in olanzapine treated patients.

Interventions

  • Drug: Olanzapine, Omega 3, Vitamin E+C
    • No adverse event nor SAE noted.

Arms, Groups and Cohorts

  • Active Comparator: Olanzapine
  • Active Comparator: Omega 3
  • Active Comparator: Vitamin E +C

Clinical Trial Outcome Measures

Primary Measures

  • PANSS
    • Time Frame: 2003-2006
    • Study completed in 2006. PI no longer with the institution. Study was closed accordingly to the HAC.
  • BMI
    • Time Frame: 2003-2006
    • BMI match height and weight.
  • Blood samples
    • Time Frame: 2003-2006
    • Samples analyzed, PI analyzed and published. PI no longer with the institution.

Secondary Measures

  • Cognitive assessments
    • Time Frame: 2003-2006
    • BACS assessment. Data analyzed and published by the PI.

Participating in This Clinical Trial

Inclusion Criteria

  • Age 18 to 55 – VA outpatient – Diagnosis of schizophrenia by DSM-IV criteria – Active treatment with olanzapine – Medically healthy Exclusion Criteria:

  • Diagnosis of MR – MMSE score of < 26 – Not on a stable dose of olanzapine

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Augusta University
  • Collaborator
    • Eli Lilly and Company
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Peter Buckley, M.D., Principal Investigator, VA MC/Medical College of Georgia

References

Jones B, Basson BR, Walker DJ, Crawford AM, Kinon BJ. Weight change and atypical antipsychotic treatment in patients with schizophrenia. J Clin Psychiatry. 2001;62 Suppl 2:41-4.

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