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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03543553
Other study ID # ecoval
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date January 1, 2025
Est. completion date March 31, 2027

Study information

Verified date November 2023
Source Oslo University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The overall objective of this project is to identify the neural signature of the impaired ability to relate socially seen in individuals with schizophrenia. A hypothesized path from the neural processes of social cognition, to social cognition assessed behaviorally, to real-life social interactions is examined. Secondary aims are to compare electrophysiological measures of high vs low level social cognition; to develop assessment methods of real-life behavior; and to increase the ecological validity of schizophrenia research. Much research within the field is devoid of personal meaning and interpersonal context. This project's use of personalized assessment allows for an ecologically valid approach to the social deficits of schizophrenia.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date March 31, 2027
Est. primary completion date March 31, 2027
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 17 Years to 55 Years
Eligibility Inclusion Criteria: - schizophrenia - schizoaffective disorder Exclusion Criteria - diabetes - Hyperthyroidism - severe head trauma - neurological disease

Study Design


Related Conditions & MeSH terms


Intervention

Other:
This is not an intervention study
This is not an intervention study

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Oslo University Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Neurophysiology: EEG EEG mu suppression paradigm using point-light displays 1 day (when assessed)
Primary Neurophysiology: ERP ERP mentalizing paradigm (perspective taking) 1 day (when assessed)
Primary Cognition Matrics Consensus Cognitive Battery 1 day (when assessed)
Primary Negative symptoms: clinician-rated Positive and Negative Syndrome Scale (PANSS) 2. Objectively assessed using computerized software (FaceReader, PRAAT) of video-taped personal narratives produced by the participants 1 day (when assessed)
Primary Negative symptoms: objective 1 FaceReader 1 day (when assessed)
Primary Negative symptoms: objective 2 PRAAT 1 day (when assessed)
Primary Social cognition: complex ToM Movie for the Assessment of Social Cognition 1 day (when assessed)
Primary Social cognition: low level ToM The Hinting Task 1 day (when assessed)
Primary Social cognition: facial emotion perception Pictures of Facial Affect 1 day (when assessed)
Primary Social cognition: body language reading Emotion in Biological Motion test 1 day (when assessed)
Primary Functioning Social Functioning Scale (SFS). Seven scales that can be combined into a total score. Mean score in a schizophrenia population = 100, SD = 15. For both the seven scales and the total score. 1 day (when assessed)
Primary Real-world behaviour Day Reconstruction Method 1 day (when assessed)
Primary Real-world social interactions Video-ethnography 1 day (when assessed)
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