Computerized Cognitive Training for Schizophrenia in Brazil
CCTSB
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 schizophrenia
Started Jan 2014
Longer than P75 for phase_3 schizophrenia
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
December 16, 2014
CompletedFirst Posted
Study publicly available on registry
October 29, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedJanuary 17, 2018
January 1, 2018
4.9 years
December 16, 2014
January 12, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
through study completion, an average of 1 year
Secondary Outcomes (20)
Processing speed score change
through study completion, an average of 1 year
Attention score change
through study completion, an average of 1 year
Working memory score change
through study completion, an average of 1 year
Verbal memory and learning score change
through study completion, an average of 1 year
Visuospatial memory and learning score change
through study completion, an average of 1 year
- +15 more secondary outcomes
Study Arms (3)
Auditory
ACTIVE COMPARATORAdministration of 40 hours of auditory training exercises
Visual
ACTIVE COMPARATORAdministration of 40 hours of visual training exercises
Video Games
PLACEBO COMPARATORAdministration of 40 hours of commercial video games
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- IQ score \<70
- active substance dependence (DSM-IV criteria)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Federal University of Rio de Janeiro
Rio de Janeiro, Rio de Janeiro, 21941590, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rogerio Panizzutti, M.D., Ph.D.
Universidade Federal do Rio de Janeiro
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
December 16, 2014
First Posted
October 29, 2015
Study Start
January 1, 2014
Primary Completion
December 1, 2018
Study Completion
December 1, 2019
Last Updated
January 17, 2018
Record last verified: 2018-01