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

NCT00211562 | Terminated Phase 3

• 1 other identifier: Omega-3 Fatty Acids
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Keywords

weight gain; weight gain supplementation; antioxidants; olanzapine

Outcome Measures

Primary Outcomes (3)

• PANSS

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

  2003-2006

• BMI

  BMI match height and weight.

  2003-2006

• Blood samples

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

  2003-2006

Secondary Outcomes (1)

• Cognitive assessments

  2003-2006

Study Arms (3)

Olanzapine

ACTIVE COMPARATOR

Drug: Olanzapine, Omega 3, Vitamin E+C

Omega 3

ACTIVE COMPARATOR

Drug: Olanzapine, Omega 3, Vitamin E+C

Vitamin E +C

ACTIVE COMPARATOR

Drug: Olanzapine, Omega 3, Vitamin E+C

Interventions

Olanzapine, Omega 3, Vitamin E+C DRUG

No adverse event nor SAE noted.

Olanzapine; Omega 3; Vitamin E +C

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18 to 55
• VA outpatient
• Diagnosis of schizophrenia by DSM-IV criteria
• Active treatment with olanzapine
• Medically healthy

You may not qualify if:

• Diagnosis of MR
• MMSE score of \< 26
• Not on a stable dose of olanzapine

Sponsors & Collaborators

• Augusta University: lead
• Eli Lilly and Company: collaborator
• Medical Service Line ABRC: collaborator
• US Department of Veterans Affairs: collaborator

Study Sites (1)

VA Medical Center

Augusta, Georgia, 30904, United States

Location

Related Publications (1)

• 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.

  PMID: 11232752 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Schizophrenia; Weight Gain

Interventions

Olanzapine; Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• Peter Buckley, M.D.

  VA MC/Medical College of Georgia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: October 1, 2005
• Primary Completion: January 1, 2006
• Last Updated: October 24, 2012

Record last verified: 2012-10

Locations

US (1)