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

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Posit Science Corporation
ClinicalTrials.gov Identifier:
NCT01422902
First received: August 22, 2011
Last updated: February 4, 2016
Last verified: February 2016
  Purpose

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 Intervention Phase
Schizophrenia
Other: Plasticity-based Cognitive Training
Other: Non-plasticity-based Training
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of a Cognitive Adaptive E-treatment in Schizophrenia-diagnosed Adults, A Remediation-based Approach

Resource links provided by NLM:


Further study details as provided by Posit Science Corporation:

Primary Outcome Measures:
  • Evaluation of the effects of plasticity-based, adaptive cognitive remediation on cognitive abilities, functional status and quality of life. [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Demonstration of equivalency in safety effects reported between treatment groups. [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 150
Study Start Date: April 2012
Study Completion Date: June 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Computer games

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01422902

Locations
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
Sponsors and Collaborators
Posit Science Corporation
National Institute of Mental Health (NIMH)
Investigators
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
  More Information

No publications provided

Responsible Party: Posit Science Corporation
ClinicalTrials.gov Identifier: NCT01422902     History of Changes
Other Study ID Numbers: BPI-1001-11  IRC2MH909833-01 
Study First Received: August 22, 2011
Last Updated: February 4, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Posit Science Corporation:
Schizophrenia
Cognitive deficits
Cognitive remediation
Software
Brain Plasticity

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on February 09, 2016