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

This study has been terminated.
Sponsor:
Collaborators:
Eli Lilly and Company
Medical Service Line ABRC
Department of Veterans Affairs
Information provided by (Responsible Party):
Georgia Regents University
ClinicalTrials.gov Identifier:
NCT00211562
First received: September 13, 2005
Last updated: October 23, 2012
Last verified: October 2012
History of Changes

September 13, 2005
October 23, 2012
October 2005
January 2006   (final data collection date for primary outcome measure)
  • PANSS [ Time Frame: 2003-2006 ] [ Designated as safety issue: No ]
    Study completed in 2006. PI no longer with the institution. Study was closed accordingly to the HAC.
  • BMI [ Time Frame: 2003-2006 ] [ Designated as safety issue: No ]
    BMI match height and weight.
  • Blood samples [ Time Frame: 2003-2006 ] [ Designated as safety issue: No ]
    Samples analyzed, PI analyzed and published. PI no longer with the institution.
  • BMI
  • Blood samples
  • PANSS
Complete list of historical versions of study NCT00211562 on ClinicalTrials.gov Archive Site
Cognitive assessments [ Time Frame: 2003-2006 ] [ Designated as safety issue: No ]
BACS assessment. Data analyzed and published by the PI.
Cognitive assessments
Not Provided
Not Provided
 
Adjunctive Supplementation of Antioxidants (Vitamins E + C) Plus Omega-3 Fatty Acids
Reduction of Body Weight in Olanzapine Treated Schizophrenia Patients by Adjunctive Supplementation of Antioxidants (Vitamins E + C) Plus Omega-3 Fatty Acids

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.

To demonstrate that supplementation of antioxidants and omega-3 fatty acids will improve clinical outcome including cognitive performance in olanzapine treated patients.
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Schizophrenia
Drug: Olanzapine, Omega 3, Vitamin E+C
No adverse event nor SAE noted.
  • Active Comparator: Olanzapine
    Intervention: Drug: Olanzapine, Omega 3, Vitamin E+C
  • Active Comparator: Omega 3
    Intervention: Drug: Olanzapine, Omega 3, Vitamin E+C
  • Active Comparator: Vitamin E +C
    Intervention: Drug: Olanzapine, Omega 3, Vitamin E+C
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. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
20
Not Provided
January 2006   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00211562
Omega-3 Fatty Acids
Not Provided
Georgia Regents University
Georgia Regents University
  • Eli Lilly and Company
  • Medical Service Line ABRC
  • Department of Veterans Affairs
Principal Investigator: Peter Buckley, M.D. VA MC/Medical College of Georgia
Georgia Regents University
October 2012

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