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

Augusta University

Status and phase: Terminated; Phase 3

Conditions: Schizophrenia

Treatments: Drug: Olanzapine, Omega 3, Vitamin E+C

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; Industry

Identifiers

NCT00211562

Omega-3 Fatty Acids

Details and patient eligibility

About

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 description

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

Enrollment: 20 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 3 patient groups

Olanzapine

Active Comparator group

Treatment:

Drug: Olanzapine, Omega 3, Vitamin E+C

Omega 3

Active Comparator group

Treatment:

Drug: Olanzapine, Omega 3, Vitamin E+C

Vitamin E +C

Active Comparator group

Treatment:

Drug: Olanzapine, Omega 3, Vitamin E+C