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Completed

NCT Number: NCT02062190

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

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

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

HCPA

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Resveratrol

Drug

100mg 2x/day

1 month

Other names: Resveratrol (10 patients), Placebo (10 patients)

Primary outcomes

  1. 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

  1. 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.

Other outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Federal University of Rio Grande do Sul

Other

Collaborators

  • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Feb 13, 2014
Registry last updated
Dec 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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