Status:
COMPLETED
Treatment of Social Cognition in Schizophrenia Trial
Lead Sponsor:
Posit Science Corporation
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
University of Minnesota
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
This study is a multi-site, prospective, parallel arm, double-blind, randomized, controlled clinical trial to assess the efficacy of an experimental software program targeting social cognitive abiliti...
Detailed Description
The primary objective of this study is to evaluate the efficacy of SocialVille, an online training program we have recently developed (with support of a Phase I SBIR award) to treat the social cogniti...
Eligibility Criteria
Inclusion
- Subjects must be between 18 and 65 years old, inclusive, at the time of study screening
- Subjects must have a diagnosis of schizophrenia as defined by an interview.
- Subjects must demonstrate adequate decisional capacity, in the judgment of the consenting study staff member, to make a choice about participating in this research study.
- Subjects must have been clinically stable (non-acute) for 8 weeks prior to consent; in the judgment of the Site Principal Investigator.
- Subjects must have been maintained on a stable treatment of antipsychotics and/or other concomitant psychotropic treatment for at least 6 weeks prior to consent.
- Subjects must have learned English before the age of 12 to ensure valid neuropsychological results.
- Subjects must have the visual, auditory, and motor capacity to use the computerized intervention in the judgment of the consenting study staff person.
- Subjects must have no more than a moderately severe rating on hallucinations and unusual thought content.
Exclusion
- Subjects should not have had a psychiatric hospitalization in the 8 weeks prior to consent.
- Subjects who appear to be intoxicated or under the influence of a controlled substance on any day of assessment must be rescheduled or discontinued based upon the discretion of the site staff evaluator.
- Subjects should not have a history of mental retardation or pervasive developmental disorder; or other neurological disorder (e.g., Traumatic Brain Injury, epilepsy, Parkinson's Disease.)
- Subjects should not have been treated within 3 years of the date of consent with a computer-based cognitive training program manufactured by Posit Science.
- Subjects should not be participating in a concurrent clinical trial that, in the judgment of the Site Principal Investigator, could affect the outcome of this one.
- Subjects must not show suicidal ideation or behaviors.
Key Trial Info
Start Date :
March 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2018
Estimated Enrollment :
149 Patients enrolled
Trial Details
Trial ID
NCT02246426
Start Date
March 1 2015
End Date
August 30 2018
Last Update
September 26 2019
Active Locations (4)
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1
Greater Los Angeles VA
Los Angeles, California, United States, 90073
2
UCLA
Los Angeles, California, United States, 90073
3
Rush University
Chicago, Illinois, United States, 60612
4
University of Minnesota
Minneapolis, Minnesota, United States, 55454