Resveratrol, Cardiovascular Risk Markers And Cognitive Performance In Patients With Schizophrenia
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
resveratrol
Sponsored by
About this trial
This is an interventional prevention trial for Schizophrenia
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.
Sites / Locations
- HCPA
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
resveratrol
corn starch
Arm Description
(10 patients) 100mg 2x/day 1 month
Outcomes
Primary Outcome Measures
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-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
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.
Full Information
NCT ID
NCT02062190
First Posted
January 15, 2014
Last Updated
December 7, 2015
Sponsor
Federal University of Rio Grande do Sul
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
1. Study Identification
Unique Protocol Identification Number
NCT02062190
Brief Title
Resveratrol, Cardiovascular Risk Markers And Cognitive Performance In Patients With Schizophrenia
Official Title
Effects of Reveratrol on Cardiovascular Risk Markers and Cognitive Performance in Patients With Schizophrenia: a Randomized Clinical Trilal
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Rio Grande do Sul
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
resveratrol
Arm Type
Active Comparator
Arm Title
corn starch
Arm Type
Placebo Comparator
Arm Description
(10 patients) 100mg 2x/day
1 month
Intervention Type
Drug
Intervention Name(s)
resveratrol
Other Intervention Name(s)
Resveratrol (10 patients), Placebo (10 patients)
Intervention Description
100mg 2x/day
1 month
Primary Outcome Measure Information:
Title
Assessment of cardiovascular risk will be realized by measurement of cytokine levels, C-reactive protein and cholesterol levels.
Description
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.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Cognitive performance will be assessed with a battery of cognitive tests and BPRS (brief psychiatric rating scale) to assess symptoms.
Description
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.
Time Frame
1 month
Other Pre-specified Outcome Measures:
Title
Nutritional evaluation will be conducted by anthropometric data and food intake by 24-hour Recall Survey.
Description
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).
Time Frame
1 month
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
HCPA
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-903
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
26840331
Citation
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.
Results Reference
derived
Learn more about this trial
Resveratrol, Cardiovascular Risk Markers And Cognitive Performance In Patients With Schizophrenia
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