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

Primary Purpose

Schizophrenia

Status

Terminated

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Olanzapine, Omega 3, Vitamin E+C

About this trial

This is an interventional prevention trial for Schizophrenia focused on measuring weight gain, weight gain supplementation, antioxidants, olanzapine

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts 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

Sites / Locations

VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Olanzapine

Omega 3

Vitamin E +C

Arm Description

Outcomes

Primary Outcome Measures

PANSS

Study completed in 2006. PI no longer with the institution. Study was closed accordingly to the HAC.

BMI

BMI match height and weight.

Blood samples

Samples analyzed, PI analyzed and published. PI no longer with the institution.

Secondary Outcome Measures

Cognitive assessments

BACS assessment. Data analyzed and published by the PI.

Full Information

NCT ID

NCT00211562

First Posted

September 13, 2005

Last Updated

October 23, 2012

Sponsor

Augusta University

Collaborators

Eli Lilly and Company, Medical Service Line ABRC, US Department of Veterans Affairs

1. Study Identification

Unique Protocol Identification Number

NCT00211562

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2012

Overall Recruitment Status

Terminated

Study Start Date

October 2005 (undefined)

Primary Completion Date

January 2006 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Augusta University

Collaborators

Eli Lilly and Company, Medical Service Line ABRC, US Department of Veterans Affairs

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Schizophrenia

Keywords

weight gain, weight gain supplementation, antioxidants, olanzapine

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Olanzapine

Arm Type

Active Comparator

Arm Title

Omega 3

Arm Type

Active Comparator

Arm Title

Vitamin E +C

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Olanzapine, Omega 3, Vitamin E+C

Intervention Description

No adverse event nor SAE noted.

Primary Outcome Measure Information:

Title

PANSS

Description

Study completed in 2006. PI no longer with the institution. Study was closed accordingly to the HAC.

Time Frame

2003-2006

Title

BMI

Description

BMI match height and weight.

Time Frame

2003-2006

Title

Blood samples

Description

Samples analyzed, PI analyzed and published. PI no longer with the institution.

Time Frame

2003-2006

Secondary Outcome Measure Information:

Title

Cognitive assessments

Description

BACS assessment. Data analyzed and published by the PI.

Time Frame

2003-2006

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peter Buckley, M.D.

Organizational Affiliation

VA MC/Medical College of Georgia

Official's Role

Principal Investigator

Facility Information:

Facility Name

VA Medical Center

City

Augusta

State/Province

Georgia

ZIP/Postal Code

30904

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

11232752

Citation

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.

Results Reference

background

Links:

URL

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

Description

Related Info

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