Treatment of Social Cognition in Schizophrenia Trial

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 cognition deficits evident in schizophrenia (DSM-IV ICD-9 Code 295.90).

SocialVille is a computerized, browser-playable program suite, designed to target information
processing in the core social cognition domains of deficit in schizophrenia. It can be used
from any internet-connected computer; through a dedicated clinician portal, the treating
clinician can register users to treatment, continuously track and monitor their performance,
and coach users throughout training. The specific aims of the study are:

1. Specific Aim 1: Evaluate the efficacy of SocialVille as a social cognition treatment in
individuals with schizophrenia. We will conduct a large-scale, multi-site, double-blind,
randomized controlled clinical trial of the SocialVille medical device vs. an active
computer games control, which approximates challenge, computer time and interaction with
experimenter. This large trial will be conducted at four sites: University of Minnesota
Medical School (site PI: Dr. Sophia Vinogradov), the Greater Los Angeles VA (Dr. Michael
Green), Rush University (Dr. Christine Hooker), and University of California, Los
Angeles (Drs. Joseph Ventura and Keith Nuechterlein). Study participants will complete
30 hours of training from home. At baseline, mid-way through training and immediately
following training, we will employ a structured assessment battery with a co-primary SC
performance measure and a co-primary functional performance measure, as well as
secondary measures of SC, functional capacity, functional outcome, motivation, and
quality of life.

2. Specific Aim 2: Identify specific populations of treatment responders and
non-responders. We will examine predictors of SC gain based on baseline participant
demographic, symptom level, computer use, SC, and functional measures, as well as on
learning rate and plateau performance measures derived over the course of SocialVille
use to determine if it is possible to identify specific populations that respond very
well to SocialVille use, or those who are unlikely to respond to SocialVille use.

3. Specific Aim 3: Evaluate the effects of training on the relatively distinct low vs.
high-level social cognition constructs. We will separately examine the effects of
training on the independent SC factors of low level social cue detection and high-level
inferential process, correlated with clinical symptoms and functional outcome,
respectively.

Inclusion Criteria:

1. Subjects must be between 18 and 65 years old, inclusive, at the time of study
screening

2. Subjects must have a diagnosis of schizophrenia as defined by an interview.

3. 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.

4. Subjects must have been clinically stable (non-acute) for 8 weeks prior to consent; in
the judgment of the Site Principal Investigator.

5. 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.

6. Subjects must have learned English before the age of 12 to ensure valid
neuropsychological results.

7. Subjects must have the visual, auditory, and motor capacity to use the computerized
intervention in the judgment of the consenting study staff person.

8. Subjects must have no more than a moderately severe rating on hallucinations and
unusual thought content.

Exclusion Criteria:

1. Subjects should not have had a psychiatric hospitalization in the 8 weeks prior to
consent.

2. 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.

3. 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.)

4. 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.

5. 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.

6. Subjects must not show suicidal ideation or behaviors.