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Computerized Cognitive Training for Schizophrenia in Brazil (CCTSB)

Primary Purpose

Schizophrenia

Status
Unknown status
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Computerized cognitive training
Sponsored by
Universidade Federal do Rio de Janeiro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring cognitive training

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • clinical diagnosis of schizophrenia or schizoaffective disorder based on DSM-IV criteria
  • age 18- 60 years
  • Portuguese as primary language (learned before age 12)
  • no major medical or neurological disorder that precludes participation in the study

Exclusion Criteria:

  • IQ score <70
  • active substance dependence (DSM-IV criteria)

Sites / Locations

  • Federal University of Rio de JaneiroRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Auditory

Visual

Video Games

Arm Description

Administration of 40 hours of auditory training exercises

Administration of 40 hours of visual training exercises

Administration of 40 hours of commercial video games

Outcomes

Primary Outcome Measures

Global cognition score change
The global cognition score is a composite measure from the MATRICS (Measurement And Treatment Research to Improve Cognition in Schizophrenia) Consensus Cognitive Battery tests

Secondary Outcome Measures

Processing speed score change
Processing speed score will be measured using the Motor task from CANTAB (Cambridge Neuropsychological Test Automated Battery) test and the category fluency
Attention score change
Attention score will be measured using the Reaction time test and Rapid visual processing CANTAB tests
Working memory score change
Working memory will be measured using the Spatial working memory CANTAB test and the digit backward
Verbal memory and learning score change
Verbal memory and learning score will be measured using the Hopkins verbal learning test
Visuospatial memory and learning score change
Visuospatial memory and learning score will be measured using the brief visuospatial memory test
Reasoning and problem solving score change
Reasoning and problem solving score will be measured using the Stockings of Cambridge CANTAB test
Reward task score change
Reward task score will be measured using the reward task (adapted from Graham Murray)
Emotional inhibition control score change
Emotional inhibition control score will be measured using the Affective go no go CANTAB test
Biological markers from the glutamatergic system change
Biological markers from the glutamatergic system will be measured using High profile liquid chromatography
Genes of neuroplasticity
Genes of neuroplasticity will be measured using candidate genotyping and Genome wide analysis
Eotaxin 1 change
Levels of eotaxin 1 will be measured using ELISA kit
Prepulse inhibition change
Prepulse inhibition will be measured via eye muscle reaction to sound
Eye-tracking change
Eye-tracking will be measured via an infrared camera while patients do cognitive tests
Electroencephalogram (EEG) change
EEG will be measured with electrodes on the surface of the skull while patients do cognitive tests
motivation scores change
Motivation scores will be measured with an interview and the Behavior Inhibition/Activation Scale questionnaire
Depression score change
Depression score will be measured using the Hamilton - Depression questionnaire
Anxiety score change
Depression score will be measured using the Hamilton - Anxiety questionnaire
Mood scores change
mood scores will be measured using the Visual analogue scale (Norris 1971)
Positive and negative syndrome scale score change
Clinical score will be measured using the Positive and Negative Syndrome Scale for Schizophrenia
Quality of Life change
Quality of life will be measured using the World Health Organization of quality of life

Full Information

First Posted
December 16, 2014
Last Updated
January 12, 2018
Sponsor
Universidade Federal do Rio de Janeiro
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1. Study Identification

Unique Protocol Identification Number
NCT02591498
Brief Title
Computerized Cognitive Training for Schizophrenia in Brazil
Acronym
CCTSB
Official Title
Computerized Cognitive Training for Schizophrenia in Brazil
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Rio de Janeiro

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to investigate the effect of a neuroplasticity-based computerized cognitive training for people with schizophrenia in the Brazilian population.
Detailed Description
Cognitive impairments are important determinants of functional outcome in schizophrenia, which are inadequately treated by antipsychotic medication. Neuroplasticity based computerized cognitive trainings have been emerging for the last two decades and are an attempt to help patients with their cognitive impairments and global functioning. The aim of this study is to perform a computerized cognitive training to improve attention, concentration, learning, clinical symptoms and quality of life in patients. The investigators are interested in testing the differential efficacy between a specific visual versus auditory computerized cognitive training and explore the biological markers that may be involved in these neuroplasticity based training processes. The investigators will conduct a 40 hours computerized, adaptable, perception specific, cognitive training program in patients with schizophrenia. Patients will come for 1 hour, daily, and perform a visual or auditory training, or control games for about 2 months. Visual and auditory exercises are chosen to be the equivalent of one another and target cognitive domains such as divided attention, working memory and social cognition. Clinical, cognitive, emotional and biomarker data will be collected before the training, half way through, and after the training, to assess progress in several aspects of their functioning and biology. The investigators hypothesize visual and auditory trainings will be effective as compared to the control games. They also expect that auditory training to be more efficient compared to the visual training because it targets sensory functions that are mostly impaired in schizophrenia, due to auditory hallucinations patients experience. The investigators also hypothesize that both trainings will improve clinical symptoms and quality of life. On a more exploratory analysis, the investigators expect to identify new biological markers of cognitive neuroplasticity, which they expect will differentiate visual and auditory paths.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
cognitive training

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Auditory
Arm Type
Active Comparator
Arm Description
Administration of 40 hours of auditory training exercises
Arm Title
Visual
Arm Type
Active Comparator
Arm Description
Administration of 40 hours of visual training exercises
Arm Title
Video Games
Arm Type
Placebo Comparator
Arm Description
Administration of 40 hours of commercial video games
Intervention Type
Behavioral
Intervention Name(s)
Computerized cognitive training
Primary Outcome Measure Information:
Title
Global cognition score change
Description
The global cognition score is a composite measure from the MATRICS (Measurement And Treatment Research to Improve Cognition in Schizophrenia) Consensus Cognitive Battery tests
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Processing speed score change
Description
Processing speed score will be measured using the Motor task from CANTAB (Cambridge Neuropsychological Test Automated Battery) test and the category fluency
Time Frame
through study completion, an average of 1 year
Title
Attention score change
Description
Attention score will be measured using the Reaction time test and Rapid visual processing CANTAB tests
Time Frame
through study completion, an average of 1 year
Title
Working memory score change
Description
Working memory will be measured using the Spatial working memory CANTAB test and the digit backward
Time Frame
through study completion, an average of 1 year
Title
Verbal memory and learning score change
Description
Verbal memory and learning score will be measured using the Hopkins verbal learning test
Time Frame
through study completion, an average of 1 year
Title
Visuospatial memory and learning score change
Description
Visuospatial memory and learning score will be measured using the brief visuospatial memory test
Time Frame
through study completion, an average of 1 year
Title
Reasoning and problem solving score change
Description
Reasoning and problem solving score will be measured using the Stockings of Cambridge CANTAB test
Time Frame
through study completion, an average of 1 year
Title
Reward task score change
Description
Reward task score will be measured using the reward task (adapted from Graham Murray)
Time Frame
through study completion, an average of 1 year
Title
Emotional inhibition control score change
Description
Emotional inhibition control score will be measured using the Affective go no go CANTAB test
Time Frame
through study completion, an average of 1 year
Title
Biological markers from the glutamatergic system change
Description
Biological markers from the glutamatergic system will be measured using High profile liquid chromatography
Time Frame
through study completion, an average of 1 year
Title
Genes of neuroplasticity
Description
Genes of neuroplasticity will be measured using candidate genotyping and Genome wide analysis
Time Frame
through study completion, an average of 1 year
Title
Eotaxin 1 change
Description
Levels of eotaxin 1 will be measured using ELISA kit
Time Frame
through study completion, an average of 1 year
Title
Prepulse inhibition change
Description
Prepulse inhibition will be measured via eye muscle reaction to sound
Time Frame
through study completion, an average of 1 year
Title
Eye-tracking change
Description
Eye-tracking will be measured via an infrared camera while patients do cognitive tests
Time Frame
through study completion, an average of 1 year
Title
Electroencephalogram (EEG) change
Description
EEG will be measured with electrodes on the surface of the skull while patients do cognitive tests
Time Frame
through study completion, an average of 1 year
Title
motivation scores change
Description
Motivation scores will be measured with an interview and the Behavior Inhibition/Activation Scale questionnaire
Time Frame
through study completion, an average of 1 year
Title
Depression score change
Description
Depression score will be measured using the Hamilton - Depression questionnaire
Time Frame
through study completion, an average of 1 year
Title
Anxiety score change
Description
Depression score will be measured using the Hamilton - Anxiety questionnaire
Time Frame
through study completion, an average of 1 year
Title
Mood scores change
Description
mood scores will be measured using the Visual analogue scale (Norris 1971)
Time Frame
through study completion, an average of 1 year
Title
Positive and negative syndrome scale score change
Description
Clinical score will be measured using the Positive and Negative Syndrome Scale for Schizophrenia
Time Frame
through study completion, an average of 1 year
Title
Quality of Life change
Description
Quality of life will be measured using the World Health Organization of quality of life
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: clinical diagnosis of schizophrenia or schizoaffective disorder based on DSM-IV criteria age 18- 60 years Portuguese as primary language (learned before age 12) no major medical or neurological disorder that precludes participation in the study Exclusion Criteria: IQ score <70 active substance dependence (DSM-IV criteria)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rogerio Panizzutti, M.D., Ph.D.
Phone
+552139386390
Email
rogerio@icb.ufrj.br
First Name & Middle Initial & Last Name or Official Title & Degree
Linda Scoriels, Ph.D.
Phone
+552139385588
Email
lindascor@yahoo.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rogerio Panizzutti, M.D., Ph.D.
Organizational Affiliation
Universidade Federal do Rio de Janeiro
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal University of Rio de Janeiro
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
21941590
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linda Scoriels, Ph.D.
Phone
+552139385588
Email
lindascor@yahoo.fr

12. IPD Sharing Statement

Learn more about this trial

Computerized Cognitive Training for Schizophrenia in Brazil

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