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

October 23, 2012 updated by: Augusta University

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Augusta, Georgia, United States, 30904
        • VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Olanzapine
Drug: Olanzapine, Omega 3, Vitamin E+C
No adverse event nor SAE noted.
Active Comparator: Omega 3
Drug: Olanzapine, Omega 3, Vitamin E+C
No adverse event nor SAE noted.
Active Comparator: Vitamin E +C
Drug: Olanzapine, Omega 3, Vitamin E+C
No adverse event nor SAE noted.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Augusta University

Collaborators

Eli Lilly and Company
US Department of Veterans Affairs
Medical Service Line ABRC

Investigators

  • Principal Investigator: Peter Buckley, M.D., VA MC/Medical College of Georgia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

January 1, 2006

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Estimate)

October 24, 2012

Last Update Submitted That Met QC Criteria

October 23, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • omega-3 fatty acids

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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