Evaluation of a Cognitive Adaptive E-treatment in Schizophrenia-diagnosed Adults (e-CAeSAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01422902
Recruitment Status : Completed
First Posted : August 25, 2011
Last Update Posted : February 8, 2016
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Posit Science Corporation

August 22, 2011
August 25, 2011
February 8, 2016
April 2012
March 2015   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01422902 on Archive Site
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.
Same as current
Not Provided
Not Provided
Evaluation of a Cognitive Adaptive E-treatment in Schizophrenia-diagnosed Adults
Evaluation of a Cognitive Adaptive E-treatment in Schizophrenia-diagnosed Adults, A Remediation-based Approach

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.

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.

Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
  • Other: Plasticity-based Cognitive Training
    Other Name: brainhq
  • Other: Non-plasticity-based Training
    Computer games
  • Experimental: Plasticity-based Cognitive Training
    Computerized plasticity-based adaptive cognitive training, up to 130 hours
    Intervention: Other: Plasticity-based Cognitive Training
  • Active Comparator: Non-plasticity-based Training
    Commercially available computerized training, up to 130 hours
    Intervention: Other: Non-plasticity-based Training
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
June 2015
March 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18 years of older with confirmed diagnosis of Schizophrenia
  • Adequate decisional and reading capacity
  • Clinical stable
  • Moderate or less severity on Positive and Negative Symptoms Scale
  • English speaker
  • Capable of completing clinical and cognitive assessment battery
  • Lack of visual, auditory or motor capacity to participate in the study
  • Minimal level of extrapyramidal symptoms
  • Minimal level of depressive symptoms

Exclusion Criteria:

  • Failure to meet suicidality rating criteria
  • Prescribed greater than 2 anti-psychotics
  • Significant alcohol and illicit drug use
  • History of mental retardation or pervasive developmental disorder or other neurological disorder
  • Prior specified computer-based cognitive remediation training
  • Participation in a concurrent study that could affect the outcome of this one
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
IRC2MH909833-01 ( Other Grant/Funding Number: National Institutes of Mental Health )
Not Provided
Not Provided
Posit Science Corporation
Posit Science Corporation
National Institute of Mental Health (NIMH)
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
Posit Science Corporation
February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP