← Back to all trials
Not Yet Recruiting
NCT07875790
Cognitive Neurocomputational Task Reliability and Clinical Applications Consortium: Study 2
Conditions: SCHIZOPHRENIA 1 (Disorder), Schizo Affective Disorder, Healthy Adult
Sex: All
Ages: 18 Years – 59 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 325
Sponsor: Washington University School of Medicine
Location: University of California Irvine Irvine California
Summary
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.
Eligibility Criteria
Inclusion Criteria:
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;
* WechslerTest of Adult Reading (WTAR) score =16+.
Group Specific Criteria: Schizophrenia/SchizoaffectiveDisorder (SZ/SZA):
* Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnosis ofschizophrenia 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 BipolarDisorder;
* no family history of psychosis or bipolar
Exclusion Criteria:
Healthy Controls (HC):
* Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5)Psychosis or Bipolar Disorder diagnosis
* Family history of psychosis, bipolar, or Schizophrenia/Schizoaffective Disorder (SZ/SZA)
additional exclusion criteria for the unmedicated individuals are:
* not in acute exacerbation requiring immediate hospitalization or treatment;
* self-reported medication non-compliance for at least the four previous weeks
* never having started medications
Source: ClinicalTrials.gov (NCT07875790). StuddyBuddy aggregates publicly available trial information.