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

NCT ID: NCT00211562

Last Updated: 2012-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Brief Summary

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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

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

Conditions

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Schizophrenia

Keywords

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weight gain weight gain supplementation antioxidants olanzapine

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Olanzapine

Group Type ACTIVE_COMPARATOR

Olanzapine, Omega 3, Vitamin E+C

Intervention Type DRUG

No adverse event nor SAE noted.

Omega 3

Group Type ACTIVE_COMPARATOR

Olanzapine, Omega 3, Vitamin E+C

Intervention Type DRUG

No adverse event nor SAE noted.

Vitamin E +C

Group Type ACTIVE_COMPARATOR

Olanzapine, Omega 3, Vitamin E+C

Intervention Type DRUG

No adverse event nor SAE noted.

Interventions

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Olanzapine, Omega 3, Vitamin E+C

No adverse event nor SAE noted.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role collaborator

Medical Service Line ABRC

UNKNOWN

Sponsor Role collaborator

US Department of Veterans Affairs

FED

Sponsor Role collaborator

Augusta University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter Buckley, M.D.

Role: PRINCIPAL_INVESTIGATOR

VA MC/Medical College of Georgia

Locations

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VA Medical Center

Augusta, Georgia, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 11232752 (View on PubMed)

Related Links

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http://www.ncbi.nlm.nih.gov

Related Info

Other Identifiers

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Omega-3 Fatty Acids

Identifier Type: -

Identifier Source: org_study_id