325 Participants NeededMy employer runs this trial

Cognitive Tasks for Schizophrenia

(CNTRACS Trial)

Recruiting at 4 trial locations
DB
CC
Overseen ByClinical Coordinator
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 1, investigators will test the ability of each of the seven paradigms to differentiate between schizophrenia (SZ)/schizoaffective disorder (SZA) and matched healthy control subjects (HC) and to predict individual differences in clinical measures of hallucinations and delusions (as well as measures of function). Investigators will also directly compare the tasks in terms of predictive ability and psychometric properties and determine whether the tasks share variance or explain unique variance. This will include determining whether hallucinations and delusions are best explained by separate underlying processes or by a single process. Investigators will also test whether the model-based parameters from these studies are more precise and sensitive than standard behavioral methods for assessing deficits across psychotic disorders and for predicting hallucinations and delusions (Aim 1). Investigators will also validate key model-based parameters against well-characterized neurophysiological measures using electroencephalogram (EEG) (Aim 4). The data from Study 1 will also be used to optimize (e.g., length, floor, and ceiling effects) tasks for Study 2. 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) \[HC, N=125\]; B) schizophrenia and schizoaffective disorder \[SZ/SZA, N=200\]). For Study 1, investigators will ensure that 40 patients are unmedicated. Investigators anticipate a \~20% screen fail/drop-out rate based on our prior Cognitive Neuroscience Test Reliability and Clinical Applications for Schizophrenia Consortium (CNTRACS) studies. Thus, investigators will run an additional 40 SZ/SZA and 15 HC. All sites have experience recruiting patients in each of these groups as indicated by our past successful studies, and the fact that investigators have been able to recruit patients with significant hallucinations and delusions in all groups. Investigators will also validate key model-based parameters against well-characterized neurophysiological measures using electroencephalogram (EEG) (Aim 4). The data from Study 1 will also be used to optimize (e.g., length, floor, and ceiling effects) tasks for Study 2. 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) \[HC, N=125\]; B) schizophrenia and schizoaffective disorder \[SZ/SZA, N=200\]). For Study 1, investigators will ensure that 40 patients are unmedicated. Investigators anticipate a \~20% screen fail/drop-out rate based on our prior Cognitive Neuroscience Test Reliability and Clinical Applications for Schizophrenia Consortium (CNTRACS) studies. Thus, investigators will run an additional 40 SZ/SZA and 15 HC. All sites have experience recruiting patients in each of these groups as indicated by our past successful studies, and the fact that investigators have been able to recruit patients with significant hallucinations and delusions in all groups.

Who Is on the Research Team?

DB

Deanna Barch, Ph.D.

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. Some participants may be unmedicated. People are selected to ensure a range of symptoms like hallucinations and delusions.

Inclusion Criteria

I am between 18 and 59 years old.
General Inclusion: no substance disorder in past six months confirmed with urine drug screens and breathalyzers
My schizophrenia medications have not changed in the past month and won't change next month.
See 6 more

Exclusion Criteria

Healthy Controls (HC): family history of psychosis or bipolar
Schizophrenia/Schizoaffective Disorder (SZ/SZA) unmedicated: not in acute exacerbation requiring immediate hospitalization or treatment
Schizophrenia/Schizoaffective Disorder (SZ/SZA) unmedicated: self-reported medication non-compliance for at least the previous four weeks
See 2 more

What Are the Treatments Tested in This Trial?

Trial Overview

Researchers are testing seven computer-based tasks to see how well they can tell apart people with psychotic disorders from healthy individuals and predict the severity of symptoms. EEG brainwave recordings will also be used in some tests.

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+

University of Chicago

Collaborator

Trials
1,086
Recruited
844,000+

University of Minnesota

Collaborator

Trials
1,459
Recruited
1,623,000+

University of California, Irvine

Collaborator

Trials
580
Recruited
4,943,000+

University of Maryland, Baltimore County

Collaborator

Trials
13
Recruited
2,400+

National Institute of Mental Health (NIMH)

Collaborator

Trials
3,007
Recruited
2,852,000+