Evaluation of a Cognitive Adaptive E-treatment in Schizophrenia-diagnosed Adults

Schizophrenia Clinical Trial

— e-CAeSAR  

Official title:

Evaluation of a Cognitive Adaptive E-treatment in Schizophrenia-diagnosed Adults, A Remediation-based Approach

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01422902
• Other study ID #: BPI-1001-11
• Secondary ID: IRC2MH909833-01
• Status: Completed
• Phase: Phase 2
• First received: August 22, 2011
• Last updated: February 4, 2016
• Start date: April 2012
• Est. completion date: June 2015

Study information

• Verified date: February 2016
• Source: Posit Science Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: June 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Other:
• Plasticity-based Cognitive Training

• Non-plasticity-based Training
Computer games

Locations

Country	Name	City	State
United States	Palo Alto Veteran's Affairs Medical Center	Palo Alto	California
United States	Posit Science Corporation	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
Posit Science Corporation	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the effects of plasticity-based, adaptive cognitive remediation on cognitive abilities, functional status and quality of life.	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.	6 Months	No
Secondary	Demonstration of equivalency in safety effects reported between treatment groups.	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.	6 Months	Yes