Resveratrol, Cardiovascular Risk Markers And Cognitive Performance In Patients With Schizophrenia
|ClinicalTrials.gov Identifier: NCT02062190|
Recruitment Status : Completed
First Posted : February 13, 2014
Last Update Posted : December 8, 2015
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Drug: resveratrol||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Effects of Reveratrol on Cardiovascular Risk Markers and Cognitive Performance in Patients With Schizophrenia: a Randomized Clinical Trilal|
|Study Start Date :||March 2014|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||May 2015|
|Active Comparator: resveratrol||
Placebo Comparator: corn starch
(10 patients) 100mg 2x/day
- Assessment of cardiovascular risk will be realized by measurement of cytokine levels, C-reactive protein and cholesterol levels. [ Time Frame: 1 month ]Assessment of cardiovascular risk will be realized by measurement of cytokine levels (IL-12p70, IL-6, IL-10, IL-1b, IL-8 and TNF-α), C-reactive protein and cholesterol levels (total cholesterol, LDL, HDL, triglycerides) in patients with schizophrenia before and after supplementation with resveratrol or placebo.
- Cognitive performance will be assessed with a battery of cognitive tests and BPRS (brief psychiatric rating scale) to assess symptoms. [ Time Frame: 1 month ]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.
- Nutritional evaluation will be conducted by anthropometric data and food intake by 24-hour Recall Survey. [ Time Frame: 1 month ]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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02062190
|Porto Alegre, RS, Brazil, 90035-903|