Behavioral Task Assessment for Schizophrenia

(CNTRACS 2 Trial)

Not yet recruiting at 4 trial locations
DB
LI
Overseen ByLori Ingram
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: Washington University School of Medicine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

In Study 2, investigators will recruit individuals with schizophrenia (SZ) and or schizoaffective disorder (SZA) and healthy controls (HC) using optimized behavioral tasks to replicate the behavioral findings from Study 1 and to assess additional psychometric properties such as test re-test reliability and practice effects.

Investigators will obtain data on: A) clinical symptoms, with detailed assessment of hallucinations and delusions; B) community functioning; and C) functional capacity, allowing us to examine clinical validity. To generate a sample with sufficient variation in hallucinations and delusions, investigators will recruit the following groups that balance feasibility with clinical relevance: A) healthy controls \[HC, N=125\]; B) schizophrenia and schizoaffective disorder \[SZ/SZA, N=200\]). Investigators anticipate a \~20% screen fail/drop-out rate based upon prior studies. Thus, investigators will run an additional 40 SZ/SZA and 15 HC.

Investigators will administer tasks optimized in Aim 1 without electroencephalogram (EEG), to this new sample of individuals with SZ/SZA and HC.

All participants will be retested after approximately 28 days and repeat clinical assessments. Although the investigators' goal is to shorten task length using the Study 1 analyses, they will administer longer tasks than optimal for public dissemination in Study 2 to determine the minimum number of trials required for acceptable reliability. Study 2 will use the same clinical and functional measures as Study 1.

Who Is on the Research Team?

DB

Deanna Barch, PhD

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This study is for adults diagnosed with schizophrenia or schizoaffective disorder, as well as healthy adults without these conditions. Participants must be able to complete behavioral tasks and attend two testing sessions about a month apart.

Inclusion Criteria

General Inclusion: no substance disorder in past six months confirmed with urine drug screens and breathalyzers
General Inclusion: Wechsler Test of Adult Reading (WTAR) score 16 or higher
Healthy Controls (HC): no family history of psychosis or bipolar disorder
See 6 more

Exclusion Criteria

Schizophrenia/Schizoaffective Disorder (SZ/SZA): unmedicated individuals with self-reported medication non-compliance for at least the previous four weeks
Schizophrenia/Schizoaffective Disorder (SZ/SZA): unmedicated individuals who have never started medications
Healthy Controls (HC): family history of psychosis, bipolar disorder, or schizophrenia/schizoaffective disorder
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete clinical, self-report, proxy function, and community function assessments over 3 sessions

3 weeks
3 visits (in-person)

Retesting

Participants return after 28 days to repeat the same 3 sessions

4 weeks
3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after retesting

4 weeks

What Are the Treatments Tested in This Trial?

Trial Overview

The trial tests how reliable certain computer-based thinking and memory tasks are over time in people with schizophrenia, schizoaffective disorder, and healthy controls. All participants do the same tasks twice, about four weeks apart.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials
2,027
Recruited
2,353,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials
3,007
Recruited
2,852,000+

University of Minnesota

Collaborator

Trials
1,459
Recruited
1,623,000+

University of Chicago

Collaborator

Trials
1,086
Recruited
844,000+

University of California, Irvine

Collaborator

Trials
580
Recruited
4,943,000+

University of Maryland, Baltimore County

Collaborator

Trials
13
Recruited
2,400+