Adjunctive Supplementation of Antioxidants (Vitamins E + C) Plus Omega-3 Fatty Acids
- Conditions
- Schizophrenia
- Interventions
- Drug: Olanzapine, Omega 3, Vitamin E+C
- Registration Number
- NCT00211562
- Lead Sponsor
- Augusta University
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 20
- Age 18 to 55
- VA outpatient
- Diagnosis of schizophrenia by DSM-IV criteria
- Active treatment with olanzapine
- Medically healthy
- Diagnosis of MR
- MMSE score of < 26
- Not on a stable dose of olanzapine
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Omega 3 Olanzapine, Omega 3, Vitamin E+C - Vitamin E +C Olanzapine, Omega 3, Vitamin E+C - Olanzapine Olanzapine, Omega 3, Vitamin E+C -
- Primary Outcome Measures
Name Time Method PANSS 2003-2006 Study completed in 2006. PI no longer with the institution. Study was closed accordingly to the HAC.
BMI 2003-2006 BMI match height and weight.
Blood samples 2003-2006 Samples analyzed, PI analyzed and published. PI no longer with the institution.
- Secondary Outcome Measures
Name Time Method Cognitive assessments 2003-2006 BACS assessment. Data analyzed and published by the PI.
Trial Locations
- Locations (1)
VA Medical Center
🇺🇸Augusta, Georgia, United States