Computerized Cognitive Training for Schizophrenia in Brazil

NCT ID: NCT02591498

Last Updated: 2018-01-17

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

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2019-12-31

Brief Summary

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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

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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.

Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Auditory

Administration of 40 hours of auditory training exercises

Group Type ACTIVE_COMPARATOR

Computerized cognitive training

Intervention Type BEHAVIORAL

Visual

Administration of 40 hours of visual training exercises

Group Type ACTIVE_COMPARATOR

Computerized cognitive training

Intervention Type BEHAVIORAL

Video Games

Administration of 40 hours of commercial video games

Group Type PLACEBO_COMPARATOR

Computerized cognitive training

Intervention Type BEHAVIORAL

Interventions

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Computerized cognitive training

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidade Federal do Rio de Janeiro

OTHER

Sponsor Role lead

Responsible Party

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Rogerio Panizzutti

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rogerio Panizzutti, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal do Rio de Janeiro

Locations

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Federal University of Rio de Janeiro

Rio de Janeiro, Rio de Janeiro, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Rogerio Panizzutti, M.D., Ph.D.

Role: CONTACT

+552139386390

Linda Scoriels, Ph.D.

Role: CONTACT

+552139385588

Facility Contacts

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Linda Scoriels, Ph.D.

Role: primary

+552139385588

Other Identifiers

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1R03TW009002-01

Identifier Type: NIH

Identifier Source: org_study_id

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