Schizophrenia Clinical Trial
Official title:
Effects of Reveratrol on Cardiovascular Risk Markers and Cognitive Performance in Patients With Schizophrenia: a Randomized Clinical Trilal
Resveratrol supplementation may improve cardiovascular risk factors and cognitive parameters in patients with schizophrenia taking antipsychotics?
Status | Completed |
Enrollment | 19 |
Est. completion date | May 2015 |
Est. primary completion date | January 2015 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: Men 18-65 years old, diagnosed with schizophrenia according to DSM-IV and ICD-10, which are in clozapine medication for at least 6 months. Exclusion Criteria: Patients will be excluded from the study: - Have a diagnosis of diabetes - Use other antipsychotic drugs, clozapine beyond - Using medicines for diabetes or dyslipidaemia - Accept not participate in any stage of the research. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Brazil | HCPA | Porto Alegre | RS |
Lead Sponsor | Collaborator |
---|---|
Federal University of Rio Grande do Sul | Coordenação de Aperfeiçoamento de Pessoal de Nível Superior. |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Nutritional evaluation will be conducted by anthropometric data and food intake by 24-hour Recall Survey. | Nutritional evaluation will be conducted by anthropometric data (weight, height, waist and hip circumference, body fat percentage) and food intake by 24-hour Recall Survey (24HR). | 1 month | Yes |
Primary | Assessment of cardiovascular risk will be realized by measurement of cytokine levels, C-reactive protein and cholesterol levels. | Assessment of cardiovascular risk will be realized by measurement of cytokine levels (IL-12p70, IL-6, IL-10, IL-1b, IL-8 and TNF-a), C-reactive protein and cholesterol levels (total cholesterol, LDL, HDL, triglycerides) in patients with schizophrenia before and after supplementation with resveratrol or placebo. | 1 month | Yes |
Secondary | Cognitive performance will be assessed with a battery of cognitive tests and BPRS (brief psychiatric rating scale) to assess symptoms. | Cognitive performance will be assessed with a battery of cognitive tests (Hopkins, for verbal memory; Stroop: for executive function; Digits WAIS-III, for attention; and Sequence numbers and letters for verbal memory and attention) and BPRS (brief psychiatric rating scale) to assess symptoms. | 1 month | Yes |
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