Clinical trial NCT01422902: Evaluation of a Cognitive Adaptive E-treatment in Schizophrenia-diagnosed Adults
Official title: Evaluation of a Cognitive Adaptive E-treatment in Schizophrenia-diagnosed Adults, A Remediation-based Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizophrenia
Keywords: Schizophrenia
Cognitive deficits
Cognitive remediation
Software
Brain Plasticity
Lead sponsor: Posit Science Corporation
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2011-08-25
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: Evaluation of the effects of plasticity-based, adaptive cognitive remediation on cognitive abilities, functional status and quality of life.
timeFrame: 6 Months
Secondary outcomes:
measure: Demonstration of equivalency in safety effects reported between treatment groups.
timeFrame: 6 Months
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Palo Alto Veteran's Affairs Medical Center
state: California
city: San Francisco
country: United States
facility: Posit Science Corporation
state: California
Study officials:
affiliation: Posit Science Corporation
name: Henry W. Mahncke, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Schizophrenia Trials Network
name: Richard Keefe, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Schizophrenia Trials Network
name: Scott Stroup, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Posit Science Corporation
name: Cate Stasio
role: STUDY_DIRECTOR
References: