Evaluation of a Cognitive Adaptive E-treatment in Schizophrenia-diagnosed Adults (e-CAeSAR)
|ClinicalTrials.gov Identifier: NCT01422902|
Recruitment Status : Completed
First Posted : August 25, 2011
Last Update Posted : February 8, 2016
This study is a multi-site, double-blind, randomized, controlled clinical trial to assess the safety and effectiveness of plasticity-based, adaptive, computerized-based cognitive remediation treatment versus a computer-based control.
The investigators proposed that a computerized cognitive remediation program based upon the principles of brain plasticity may improve information processing and thus drive clinically significant improvements in cognitive and functional performance in individuals with schizophrenia.
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Other: Plasticity-based Cognitive Training Other: Non-plasticity-based Training||Phase 2|
The symptoms of schizophrenia fall into three main categories: positive symptoms, negative symptoms, and cognitive symptoms. Each category represents distinct functional challenges and impedes patient productivity and overall quality of life.
Cognitive symptoms are pervasive and result in deficits in executive functioning (the ability to understand information and use it to make decisions), attention (the ability to identify, select, and focus on relevant sensory events), and working memory (the ability to hold information in memory and then guide actions from it). These symptoms impair patients' abilities to successfully perform everyday activities, including independent living, employment, and social relationships, and in addition can cause great emotional distress.
Cognitive impairment in schizophrenia has now received substantial academic study, with over 24,000 research papers published in the field since 1990. This enormous body of work has shown that cognitive impairment is likely to be present in virtually all patients with schizophrenia, regardless of their severity of illness or treatment status. People with schizophrenia typically perform 1-2 standard deviations below the mean of age-matched controls (indicating substantial impairment) across the domains of speed of information processing, attention, working memory, verbal and visual learning, reasoning and social cognition.
While cognitive impairment in schizophrenia was originally assumed to be secondary to positive or negative symptoms of the disorder, or related to the use of anti-psychotic medications, recent research has conclusively shown that neither of these past assumptions is true. For example, the landmark Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) trial involving 1,493 participants demonstrated that negative symptoms are only mildly correlated with cognitive function, and that positive symptoms are completely uncorrelated with cognitive function. Furthermore, research has shown that cognitive impairment is evident in people with schizophrenia before they are medicated, prior to diagnosis, and in first-degree relatives of people diagnosed with schizophrenia; indicating that medication is not the cause of cognitive impairment. In aggregate, these data have established the well-accepted current viewpoint that cognitive dysfunction is a core primary symptom and deficit in schizophrenia.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||Evaluation of a Cognitive Adaptive E-treatment in Schizophrenia-diagnosed Adults, A Remediation-based Approach|
|Study Start Date :||April 2012|
|Primary Completion Date :||March 2015|
|Study Completion Date :||June 2015|
Experimental: Plasticity-based Cognitive Training
Computerized plasticity-based adaptive cognitive training, up to 130 hours
Other: Plasticity-based Cognitive Training
Other Name: brainhq
Active Comparator: Non-plasticity-based Training
Commercially available computerized training, up to 130 hours
Other: Non-plasticity-based Training
- Evaluation of the effects of plasticity-based, adaptive cognitive remediation on cognitive abilities, functional status and quality of life. [ Time Frame: 6 Months ]Each outcome score (MCCB composite score and UPSA-2 total score) will be analyzed separately. The treatment efficacy will be established if and only if both tests on MCCB and UPSA-2 are significant at two-sided alpha level of 0.05.
- Demonstration of equivalency in safety effects reported between treatment groups. [ Time Frame: 6 Months ]Positive and Negative Symptom Scale (PANSS) positive symptom scale, negative symptom scale and total scale will be assessed at study mid-point and study end. Adverse effects by treatment group will also be assessed at study mid-point and study end.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01422902
|United States, California|
|Palo Alto Veteran's Affairs Medical Center|
|Palo Alto, California, United States, 94304|
|Posit Science Corporation|
|San Francisco, California, United States, 94108|
|Principal Investigator:||Henry W. Mahncke, PhD||Posit Science Corporation|
|Principal Investigator:||Richard Keefe, PhD||Schizophrenia Trials Network|
|Principal Investigator:||Scott Stroup, MD, MPH||Schizophrenia Trials Network|
|Study Director:||Cate Stasio||Posit Science Corporation|