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

This study has been terminated.
Sponsor:
Collaborators:
Eli Lilly and Company
Medical Service Line ABRC
VA Office of Research and Development
Information provided by (Responsible Party):
Augusta University
ClinicalTrials.gov Identifier:
NCT00211562
First received: September 13, 2005
Last updated: October 23, 2012
Last verified: October 2012
  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, Omega 3, Vitamin E+C
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Reduction of Body Weight in Olanzapine Treated Schizophrenia Patients by Adjunctive Supplementation of Antioxidants (Vitamins E + C) Plus Omega-3 Fatty Acids

Resource links provided by NLM:


Further study details as provided by Augusta University:

Primary Outcome Measures:
  • PANSS [ Time Frame: 2003-2006 ] [ Designated as safety issue: No ]
    Study completed in 2006. PI no longer with the institution. Study was closed accordingly to the HAC.

  • BMI [ Time Frame: 2003-2006 ] [ Designated as safety issue: No ]
    BMI match height and weight.

  • Blood samples [ Time Frame: 2003-2006 ] [ Designated as safety issue: No ]
    Samples analyzed, PI analyzed and published. PI no longer with the institution.


Secondary Outcome Measures:
  • Cognitive assessments [ Time Frame: 2003-2006 ] [ Designated as safety issue: No ]
    BACS assessment. Data analyzed and published by the PI.


Enrollment: 20
Study Start Date: October 2005
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Olanzapine Drug: Olanzapine, Omega 3, Vitamin E+C
No adverse event nor SAE noted.
Active Comparator: Omega 3 Drug: Olanzapine, Omega 3, Vitamin E+C
No adverse event nor SAE noted.
Active Comparator: Vitamin E +C Drug: Olanzapine, Omega 3, Vitamin E+C
No adverse event nor SAE noted.

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   (Adult)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Augusta University
Eli Lilly and Company
Medical Service Line ABRC
VA Office of Research and Development
Investigators
Principal Investigator: Peter Buckley, M.D. VA MC/Medical College of Georgia
  More Information

Additional Information:
Publications:
Responsible Party: Augusta University
ClinicalTrials.gov Identifier: NCT00211562     History of Changes
Other Study ID Numbers: Omega-3 Fatty Acids 
Study First Received: September 13, 2005
Last Updated: October 23, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Augusta University:
weight gain
weight gain supplementation
antioxidants
olanzapine

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Vitamins
Vitamin E
Tocopherols
Tocotrienols
Alpha-Tocopherol
Antioxidants
Olanzapine
Micronutrients
Growth Substances
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Protective Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Neurotransmitter Agents
Serotonin Agents

ClinicalTrials.gov processed this record on September 26, 2016