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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02062190
• Other study ID #: RESV-110553
• Secondary ID: ufrgs110553
• Status: Completed
• Phase: Phase 2
• First received: January 15, 2014
• Last updated: December 7, 2015
• Start date: March 2014
• Est. completion date: May 2015

Study information

• Verified date: December 2015
• Source: Federal University of Rio Grande do Sul
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationBrazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: May 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• resveratrol
100mg 2x/day 1 month

Locations

Country	Name	City	State
Brazil	HCPA	Porto Alegre	RS

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of Rio Grande do Sul	Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Nutritional evaluation will be conducted by anthropometric data and food intake by 24-hour Recall Survey.	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).	1 month	Yes
Primary	Assessment of cardiovascular risk will be realized by measurement of cytokine levels, C-reactive protein and cholesterol levels.	Assessment of cardiovascular risk will be realized by measurement of cytokine levels (IL-12p70, IL-6, IL-10, IL-1b, IL-8 and TNF-a), C-reactive protein and cholesterol levels (total cholesterol, LDL, HDL, triglycerides) in patients with schizophrenia before and after supplementation with resveratrol or placebo.	1 month	Yes
Secondary	Cognitive performance will be assessed with a battery of cognitive tests and BPRS (brief psychiatric rating scale) to assess symptoms.	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.	1 month	Yes