Resveratrol, Cardiovascular Risk Markers And Cognitive Performance In Patients With Schizophrenia

Phase 2

Completed

• Conditions: Schizophrenia
• Interventions: Drug: resveratrol

• Registration Number: NCT02062190
• Lead Sponsor: Federal University of Rio Grande do Sul

Brief Summary

Resveratrol supplementation may improve cardiovascular risk factors and cognitive parameters in patients with schizophrenia taking antipsychotics?

Detailed Description

Randomized, double-blind, placebo-controlled trial comparing supplementation with resveratrol or placebo in patients diagnosed with schizophrenia.

Study Timeline

• Study First Submitted: 2014-01-15
• Study First Submitted QC: 2014-02-11
• Study First Posted: 2014-02-13
• Study Start: 2014-03
• Primary Completion: 2015-01
• Study Completion: 2015-05
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-07
• Last Update Posted: 2015-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 19

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
resveratrol	resveratrol	-
corn starch	resveratrol	(10 patients) 100mg 2x/day 1 month

Primary Outcome Measures

Name	Time	Method
Assessment of cardiovascular risk will be realized by measurement of cytokine levels, C-reactive protein and cholesterol levels.	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.

Secondary Outcome Measures

Name	Time	Method
Cognitive performance will be assessed with a battery of cognitive tests and BPRS (brief psychiatric rating scale) to assess symptoms.	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.

Trial Locations

Locations (1)

HCPA; 🇧🇷 Porto Alegre, RS, Brazil