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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2014 by Federal University of Rio Grande do Sul
Sponsor:
Collaborator:
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Information provided by (Responsible Party):
Karine Zortéa, Federal University of Rio Grande do Sul
ClinicalTrials.gov Identifier:
NCT02062190
First received: January 15, 2014
Last updated: February 11, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention Phase
Schizophrenia
Drug: resveratrol
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Reveratrol on Cardiovascular Risk Markers and Cognitive Performance in Patients With Schizophrenia: a Randomized Clinical Trilal

Resource links provided by NLM:


Further study details as provided by Federal University of Rio Grande do Sul:

Primary Outcome Measures:
  • Assessment of cardiovascular risk will be realized by measurement of cytokine levels, C-reactive protein and cholesterol levels. [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    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. [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • Nutritional evaluation will be conducted by anthropometric data and food intake by 24-hour Recall Survey. [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    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).


Estimated Enrollment: 20
Study Start Date: March 2014
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: resveratrol Drug: resveratrol

100mg 2x/day

1 month

Other Names:
  • Resveratrol (10 patients)
  • Placebo (10 patients)
Placebo Comparator: corn starch

(10 patients) 100mg 2x/day

1 month


Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02062190

Contacts
Contact: Karine Zortéa karine.persobnaldiet@gmail.com

Locations
Brazil
HCPA Not yet recruiting
Porto Alegre, RS, Brazil, 90035-903
Contact: Karine Zortéa, MD    84296901    karine.personaldiet@gmail.com   
Principal Investigator: Karine Zortéa, MD         
Sponsors and Collaborators
Federal University of Rio Grande do Sul
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
  More Information

No publications provided

Responsible Party: Karine Zortéa, Master, Federal University of Rio Grande do Sul
ClinicalTrials.gov Identifier: NCT02062190     History of Changes
Other Study ID Numbers: RESV-110553, ufrgs110553
Study First Received: January 15, 2014
Last Updated: February 11, 2014
Health Authority: United States: Food and Drug Administration
Brazil: Ethics Committee

Additional relevant MeSH terms:
Resveratrol
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Enzyme Inhibitors
Platelet Aggregation Inhibitors
Hematologic Agents
Antimutagenic Agents
Anticarcinogenic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 18, 2014