NCT03543553

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
11mo left

Started Jan 2025

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress60%
Jan 2025Mar 2027

First Submitted

Initial submission to the registry

April 17, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 1, 2018

Completed
6.6 years until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

November 28, 2023

Status Verified

November 1, 2023

Enrollment Period

2.2 years

First QC Date

April 17, 2018

Last Update Submit

November 27, 2023

Conditions

Outcome Measures

Primary Outcomes (13)

  • Neurophysiology: EEG

    EEG mu suppression paradigm using point-light displays

    1 day (when assessed)

  • Neurophysiology: ERP

    ERP mentalizing paradigm (perspective taking)

    1 day (when assessed)

  • Cognition

    Matrics Consensus Cognitive Battery

    1 day (when assessed)

  • 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)

  • Negative symptoms: objective 1

    FaceReader

    1 day (when assessed)

  • Negative symptoms: objective 2

    PRAAT

    1 day (when assessed)

  • Social cognition: complex ToM

    Movie for the Assessment of Social Cognition

    1 day (when assessed)

  • Social cognition: low level ToM

    The Hinting Task

    1 day (when assessed)

  • Social cognition: facial emotion perception

    Pictures of Facial Affect

    1 day (when assessed)

  • Social cognition: body language reading

    Emotion in Biological Motion test

    1 day (when assessed)

  • 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)

  • Real-world behaviour

    Day Reconstruction Method

    1 day (when assessed)

  • Real-world social interactions

    Video-ethnography

    1 day (when assessed)

Study Arms (2)

SZ

Individuals with a diagnosis of schizophrenia

Other: This is not an intervention study

HC

Healthy control participants

Other: This is not an intervention study

Interventions

This is not an intervention study

HCSZ

Eligibility Criteria

Age17 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Individuals with a diagnosis of schizophrenia will be compared to healthy control participants

You may qualify if:

  • schizophrenia
  • schizoaffective disorder

You may not qualify if:

  • diabetes
  • Hyperthyroidism
  • severe head trauma
  • neurological disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

SchizophreniaCognitive DysfunctionSocial Skills

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersCognition DisordersNeurocognitive DisordersSocial BehaviorBehavior

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

April 17, 2018

First Posted

June 1, 2018

Study Start

January 1, 2025

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2027

Last Updated

November 28, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share