Schizophrenia Clinical Trial
— e-CAeSAROfficial title:
Evaluation of a Cognitive Adaptive E-treatment in Schizophrenia-diagnosed Adults, A Remediation-based Approach
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 |
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.
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Palo Alto Veteran's Affairs Medical Center | Palo Alto | California |
United States | Posit Science Corporation | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
Posit Science Corporation | National Institute of Mental Health (NIMH) |
United States,
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 |
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