Computerized Cognitive Training for Schizophrenia in Brazil

Schizophrenia Clinical Trial

— CCTSB  

Official title:

Computerized Cognitive Training for Schizophrenia in Brazil

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02591498
• Other study ID #: 1R03TW009002-01
• Status: Recruiting
• Phase: Phase 3
• First received: December 16, 2014
• Last updated: January 12, 2018
• Start date: January 2014
• Est. completion date: December 2019

Study information

• Verified date: January 2018
• Source: Universidade Federal do Rio de Janeiro
• Contact: Rogerio Panizzutti, M.D., Ph.D.
• Phone: +552139386390
• Email: rogerio[@]icb.ufrj.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Behavioral:
• Computerized cognitive training

Locations

Country	Name	City	State
Brazil	Federal University of Rio de Janeiro	Rio de Janeiro	RJ

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal do Rio de Janeiro

Country where clinical trial is conducted

Brazil, 

Outcome

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