Treatment of Social Cognition in Schizophrenia Trial

Completed · Not applicable

Conditions studied: Schizophrenia

In brief

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 abilities versus a computer-based software control. Both the study and the software being investigated meet the criteria of Non-Significant Risk.

Key facts

Study ID

NCT02246426

Run by

Posit Science Corporation

People needed

149

Starts

2015-03-01

Expected to finish

2018-08-30

Last updated by the study team

2019-09-26

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Greater Los Angeles VA — Los Angeles, California, United States
• UCLA — Los Angeles, California, United States
• Rush University — Chicago, Illinois, United States
• University of Minnesota — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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