Clinical trial NCT02591498: Computerized Cognitive Training for Schizophrenia in Brazil
Official title: Computerized Cognitive Training for Schizophrenia in Brazil
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Schizophrenia
Keywords: cognitive training
Lead sponsor: Universidade Federal do Rio de Janeiro
Sponsor class: OTHER
First posted: 2015-10-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Global cognition score change
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Processing speed score change
timeFrame: through study completion, an average of 1 year
measure: Attention score change
timeFrame: through study completion, an average of 1 year
measure: Working memory score change
timeFrame: through study completion, an average of 1 year
measure: Verbal memory and learning score change
timeFrame: through study completion, an average of 1 year
measure: Visuospatial memory and learning score change
timeFrame: through study completion, an average of 1 year
measure: Reasoning and problem solving score change
timeFrame: through study completion, an average of 1 year
measure: Reward task score change
timeFrame: through study completion, an average of 1 year
measure: Emotional inhibition control score change
timeFrame: through study completion, an average of 1 year
measure: Biological markers from the glutamatergic system change
timeFrame: through study completion, an average of 1 year
measure: Genes of neuroplasticity
timeFrame: through study completion, an average of 1 year
measure: Eotaxin 1 change
timeFrame: through study completion, an average of 1 year
measure: Prepulse inhibition change
timeFrame: through study completion, an average of 1 year
measure: Eye-tracking change
timeFrame: through study completion, an average of 1 year
measure: Electroencephalogram (EEG) change
timeFrame: through study completion, an average of 1 year
measure: motivation scores change
timeFrame: through study completion, an average of 1 year
measure: Depression score change
timeFrame: through study completion, an average of 1 year
measure: Anxiety score change
timeFrame: through study completion, an average of 1 year
measure: Mood scores change
timeFrame: through study completion, an average of 1 year
measure: Positive and negative syndrome scale score change
timeFrame: through study completion, an average of 1 year
measure: Quality of Life change
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Federal University of Rio de Janeiro
state: RJ
Study officials:
affiliation: Universidade Federal do Rio de Janeiro
name: Rogerio Panizzutti, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: