CClinicalTrials.gg
TerminatedNCT00211562Updated Oct 24, 2012

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

A Phase 3 interventional study of Olanzapine, Omega 3, Vitamin E+C in Schizophrenia, sponsored by Augusta University. Terminated at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-10-24.

Sponsored by Augusta University · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
20
Allocation
Non-randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

Read the detailed description

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

02

Conditions studied

  • Schizophrenia

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Keywords

  • weight gain
  • weight gain supplementation
  • antioxidants
  • olanzapine
03

In context

Schizophrenia

3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.

This study's enrollment of 20 is below the median of 70 across 2,872 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

Augusta University is the lead sponsor of 177 studies on the registry; 24 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 3 (30%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts 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

Exclusion Criteria:

  • Diagnosis of MR
  • MMSE score of \< 26
  • Not on a stable dose of olanzapine
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Active comparator
    Olanzapine

    Drug: Olanzapine, Omega 3, Vitamin E+C

  • Active comparator
    Omega 3

    Drug: Olanzapine, Omega 3, Vitamin E+C

  • Active comparator
    Vitamin E +C

    Drug: Olanzapine, Omega 3, Vitamin E+C

Interventions

  • DrugOlanzapine, Omega 3, Vitamin E+C

    No adverse event nor SAE noted.

06

What researchers measure

Primary outcomes

  1. PANSS

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

    Time frame: 2003-2006

  2. BMI

    BMI match height and weight.

    Time frame: 2003-2006

  3. Blood samples

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

    Time frame: 2003-2006

Secondary outcomes

  1. Cognitive assessments

    BACS assessment. Data analyzed and published by the PI.

    Time frame: 2003-2006

07

Study locations

1 site
  • VA Medical Center
    Augusta, Georgia 30904, United States
08

References and documents

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. PubMed 11232752 ↗

Related links

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 24, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00211562
Lead sponsor
Augusta University
Collaborators
Eli Lilly and Company, Medical Service Line ABRC, US Department of Veterans Affairs
Responsible party
Sponsor
First posted
Sep 21, 2005
Start date
Oct 2005
Primary completion
Jan 2006
Last update
Oct 24, 2012

Study contacts

Peter Buckley, M.D.
principal investigator · VA MC/Medical College of Georgia
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.

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