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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00211562
• Other study ID #: Omega-3 Fatty Acids
• Status: Terminated
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: October 23, 2012
• Start date: October 2005

Study information

• Verified date: October 2012
• Source: Georgia Regents University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. primary completion date: January 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Olanzapine, Omega 3, Vitamin E+C
No adverse event nor SAE noted.

Locations

Country	Name	City	State
United States	VA Medical Center	Augusta	Georgia

Sponsors (4)

Lead Sponsor	Collaborator
Georgia Regents University	Eli Lilly and Company, Medical Service Line ABRC, VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PANSS	Study completed in 2006. PI no longer with the institution. Study was closed accordingly to the HAC.	2003-2006	No
Primary	BMI	BMI match height and weight.	2003-2006	No
Primary	Blood samples	Samples analyzed, PI analyzed and published. PI no longer with the institution.	2003-2006	No
Secondary	Cognitive assessments	BACS assessment. Data analyzed and published by the PI.	2003-2006	No

External Links

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