NCT07853807Recruiting
Cognitive Neurocomputational Task Reliability & Clinical Applications Consortium (CNTRACS): Study 1
Cognitive Neurocomputational Task Reliability & Clinical Applications Consortium
Source: ClinicalTrials.gov · Last updated 2 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 325 (estimated)
- First submitted
- 11 Sept 2026
- Start date
- 1 Oct 2026
- Primary completion date
- 30 Jun 2031
- Lead sponsor
- Washington University School of Medicine
- Diseases
- Schizophrenia
- NCT number
- NCT07853807
What you commit to
- Study type: Interventional
- Planned participants: 325
- From 1 Oct 2026 to the primary completion date, 30 Jun 2031
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- self-reported medication non-compliance for at least the four previous weeks 3)never having started medications
Other illness
- Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) Psychosis or Bipolar Disorder diagnosis
- Family history of psychosis or bipolar
- Schizophrenia/Schizoaffective Disorder (SZ/SZA): additional exclusion criteria for the unmedicated individuals are:
Other
- Healthy Controls (HC):
- not in acute exacerbation requiring immediate hospitalization or treatment
Who the study is looking for
- General Inclusion
- age 18 to 59
- no substance disorder in past six months (confirmed with urine drug screens and breathalyzers);
- no clinically significant head injury or neurological disease. 4. Wechsler Test of Adult Reading (WTAR) score =16+.
- Group Specific Criteria: Schizophrenia/Schizoaffective Disorder (SZ):
- Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnosis of schizophrenia or schizoaffective;
- no medication changes in prior month or anticipated in the next month or not taking medications
- outpatient or partial hospital if unmedicated
- Healthy Controls (HC):
- no Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) Psychosis or Bipolar Disorder;
- no family history of psychosis or bipolar
Age in the registry: 18 years to 59 years · Sex: All · Accepts healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Maryland, Baltimore Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
| The University Of Chicago Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| University of California, Irvine Coordinator of this site? Confirm its status | Irvine | United States | Recruiting |
| University of Minnesota Coordinator of this site? Confirm its status | Minneapolis | United States | Recruiting |
| Washington University Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.