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

NCT ID: NCT02062190

Last Updated: 2015-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2015-05-31

Brief Summary

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

Detailed Description

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

Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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resveratrol

Group Type ACTIVE_COMPARATOR

resveratrol

Intervention Type DRUG

100mg 2x/day

1 month

corn starch

(10 patients) 100mg 2x/day

1 month

Group Type PLACEBO_COMPARATOR

resveratrol

Intervention Type DRUG

100mg 2x/day

1 month

Interventions

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resveratrol

100mg 2x/day

1 month

Intervention Type DRUG

Other Intervention Names

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Resveratrol (10 patients) Placebo (10 patients)

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

OTHER_GOV

Sponsor Role collaborator

Federal University of Rio Grande do Sul

OTHER

Sponsor Role lead

Responsible Party

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Karine Zortéa

Master

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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HCPA

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Countries

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Brazil

References

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Zortea K, Franco VC, Francesconi LP, Cereser KM, Lobato MI, Belmonte-de-Abreu PS. Resveratrol Supplementation in Schizophrenia Patients: A Randomized Clinical Trial Evaluating Serum Glucose and Cardiovascular Risk Factors. Nutrients. 2016 Jan 29;8(2):73. doi: 10.3390/nu8020073.

Reference Type DERIVED
PMID: 26840331 (View on PubMed)

Other Identifiers

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ufrgs110553

Identifier Type: OTHER

Identifier Source: secondary_id

RESV-110553

Identifier Type: -

Identifier Source: org_study_id