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Clinical Trials/NCT02062190
NCT02062190
Completed
Phase 2

Effects of Reveratrol on Cardiovascular Risk Markers and Cognitive Performance in Patients With Schizophrenia: a Randomized Clinical Trilal

Federal University of Rio Grande do Sul1 site in 1 country19 target enrollmentMarch 2014
ConditionsSchizophrenia
Interventionsresveratrol

Overview

Phase
Phase 2
Intervention
resveratrol
Conditions
Schizophrenia
Sponsor
Federal University of Rio Grande do Sul
Enrollment
19
Locations
1
Primary Endpoint
Assessment of cardiovascular risk will be realized by measurement of cytokine levels, C-reactive protein and cholesterol levels.
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2014
End Date
May 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Sponsor
Federal University of Rio Grande do Sul
Responsible Party
Principal Investigator
Principal Investigator

Karine Zortéa

Master

Federal University of Rio Grande do Sul

Eligibility Criteria

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.

Arms & Interventions

resveratrol

Intervention: resveratrol

corn starch

(10 patients) 100mg 2x/day 1 month

Intervention: resveratrol

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Cognitive performance will be assessed with a battery of cognitive tests and BPRS (brief psychiatric rating scale) to assess symptoms.(1 month)

Study Sites (1)

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