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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00211562

Enrollment

Registered

2005-09-21

Start date

2005-10-31

Completion date

Unknown

Last updated

2012-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

weight gain, weight gain supplementation, antioxidants, olanzapine

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.

Interventions

DRUGOlanzapine, Omega 3, Vitamin E+C

No adverse event nor SAE noted.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026