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

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

This study has been terminated.

Sponsors and Collaborators:	Medical College of Georgia Eli Lilly and Company Medical Service Line ABRC Department of Veterans Affairs
Information provided by:	Medical College of Georgia
ClinicalTrials.gov Identifier:	NCT00211562

Purpose

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.

Condition	Intervention	Phase
Schizophrenia	Drug: Olanzapine	Phase III

MedlinePlus related topics:

Antioxidants Schizophrenia

ChemIDplus related topics:

Vitamin E alpha-Tocopherol alpha-Tocopheryl acetate Tocopherols Olanzapine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Active Control, Pharmacodynamics Study

Official Title:	Reduction of Body Weight in Olanzapine Treated Schizophrenia Patients by Adjunctive Supplementation of Antioxidants (Vitamins E + C) Plus Omega-3 Fatty Acids

Further study details as provided by Medical College of Georgia:

Primary Outcome Measures:

PANSS
BMI
Blood samples

Secondary Outcome Measures:

Cognitive assessments

Estimated Enrollment:	20
Study Start Date:	October 2005

Detailed Description:

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

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00211562

Locations


United States, Georgia
	VA Medical Center
	Augusta, Georgia, United States, 30904

Sponsors and Collaborators

Medical College of Georgia

Eli Lilly and Company

Medical Service Line ABRC

Department of Veterans Affairs

Investigators


Principal Investigator:	Peter Buckley, M.D.	VA MC/Medical College of Georgia

More Information

Related Info This link exits the ClinicalTrials.gov site

Publications:

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. Review.

Study ID Numbers:	Omega-3 Fatty Acids
First Received:	September 13, 2005
Last Updated:	February 12, 2007
ClinicalTrials.gov Identifier:	NCT00211562
Health Authority:	United States: Food and Drug Administration

Keywords provided by Medical College of Georgia:

weight gain

weight gain supplementation

antioxidants

olanzapine

Study placed in the following topic categories:

Tocopherols

Schizophrenia

Body Weight

Tocopherol acetate

Vitamin E

Mental Disorders

Olanzapine

Psychotic Disorders

Weight Gain

Serotonin

Schizophrenia and Disorders with Psychotic Features

Alpha-Tocopherol

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors

Neurotransmitter Agents

Tranquilizing Agents

Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs

Gastrointestinal Agents

Psychotropic Drugs

Antiemetics

Central Nervous System Depressants

Antipsychotic Agents

Serotonin Uptake Inhibitors

Pharmacologic Actions

Serotonin Agents

Autonomic Agents

Therapeutic Uses

Peripheral Nervous System Agents

Central Nervous System Agents

ClinicalTrials.gov processed this record on October 03, 2008