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NCT07853807Toboroz

Cognitive Neurocomputational Task Reliability & Clinical Applications Consortium (CNTRACS): Study 1

Cognitive Neurocomputational Task Reliability & Clinical Applications Consortium

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 2.

Következő lépések

Rövid összefoglaló (regiszter, angolul)

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.

Állapot (regiszter)
Toboroz
Vizsgálattípus
Beavatkozással járó
Résztvevők száma
325 (tervezett)
Első benyújtás
2026. szept. 11.
Kezdés
2026. okt. 1.
Elsődleges befejezés
2031. jún. 30.
Fő szponzor
Washington University School of Medicine
Betegségek
Skizofrénia
NCT-szám
NCT07853807

Mit vállalsz

  • Vizsgálat típusa: Beavatkozással járó
  • Tervezett résztvevők: 325
  • 2026. okt. 1. és az elsődleges befejezés (2031. jún. 30.) között
  • 5 helyszín, 1 országban
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

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Korábbi kezelés

  • self-reported medication non-compliance for at least the four previous weeks 3)never having started medications

Más betegség

  • 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:

Egyéb

  • Healthy Controls (HC):
  • not in acute exacerbation requiring immediate hospitalization or treatment

Kiket keres a vizsgálat

  • 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

Életkor a regiszterben: 18 év – 59 év · Nem: nők és férfiak · Egészséges önkénteseket is fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (5)

Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.

HelyszínVárosOrszágHelyszín állapota
University of Maryland, BaltimoreBaltimoreEgyesült ÁllamokToboroz
The University Of ChicagoChicagoEgyesült ÁllamokToboroz
University of California, IrvineIrvineEgyesült ÁllamokToboroz
University of MinnesotaMinneapolisEgyesült ÁllamokToboroz
Washington UniversitySt LouisEgyesült ÁllamokToboroz

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