Adjunctive Supplementation of Antioxidants (Vitamins E + C) Plus Omega-3 Fatty Acids
Primary Purpose
Schizophrenia
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Olanzapine, Omega 3, Vitamin E+C
Sponsored by
About this trial
This is an interventional prevention trial for Schizophrenia focused on measuring weight gain, weight gain supplementation, antioxidants, olanzapine
Eligibility Criteria
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
Sites / Locations
- VA Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Olanzapine
Omega 3
Vitamin E +C
Arm Description
Outcomes
Primary Outcome Measures
PANSS
Study completed in 2006. PI no longer with the institution. Study was closed accordingly to the HAC.
BMI
BMI match height and weight.
Blood samples
Samples analyzed, PI analyzed and published. PI no longer with the institution.
Secondary Outcome Measures
Cognitive assessments
BACS assessment. Data analyzed and published by the PI.
Full Information
NCT ID
NCT00211562
First Posted
September 13, 2005
Last Updated
October 23, 2012
Sponsor
Augusta University
Collaborators
Eli Lilly and Company, Medical Service Line ABRC, US Department of Veterans Affairs
1. Study Identification
Unique Protocol Identification Number
NCT00211562
Brief Title
Adjunctive Supplementation of Antioxidants (Vitamins E + C) Plus Omega-3 Fatty Acids
Official Title
Reduction of Body Weight in Olanzapine Treated Schizophrenia Patients by Adjunctive Supplementation of Antioxidants (Vitamins E + C) Plus Omega-3 Fatty Acids
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Terminated
Study Start Date
October 2005 (undefined)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Augusta University
Collaborators
Eli Lilly and Company, Medical Service Line ABRC, US Department of Veterans Affairs
4. Oversight
5. Study Description
Brief Summary
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.
Detailed Description
To demonstrate that supplementation of antioxidants and omega-3 fatty acids will improve clinical outcome including cognitive performance in olanzapine treated patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
weight gain, weight gain supplementation, antioxidants, olanzapine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Olanzapine
Arm Type
Active Comparator
Arm Title
Omega 3
Arm Type
Active Comparator
Arm Title
Vitamin E +C
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Olanzapine, Omega 3, Vitamin E+C
Intervention Description
No adverse event nor SAE noted.
Primary Outcome Measure Information:
Title
PANSS
Description
Study completed in 2006. PI no longer with the institution. Study was closed accordingly to the HAC.
Time Frame
2003-2006
Title
BMI
Description
BMI match height and weight.
Time Frame
2003-2006
Title
Blood samples
Description
Samples analyzed, PI analyzed and published. PI no longer with the institution.
Time Frame
2003-2006
Secondary Outcome Measure Information:
Title
Cognitive assessments
Description
BACS assessment. Data analyzed and published by the PI.
Time Frame
2003-2006
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Buckley, M.D.
Organizational Affiliation
VA MC/Medical College of Georgia
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Medical Center
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30904
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
11232752
Citation
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.
Results Reference
background
Links:
URL
http://www.ncbi.nlm.nih.gov
Description
Related Info
Learn more about this trial
Adjunctive Supplementation of Antioxidants (Vitamins E + C) Plus Omega-3 Fatty Acids
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