NCT04768335

Brief Summary

Schizophrenia is a mental illness with a variety of clinical symptoms that can be regrouped into 2 categories: positive and negative symptoms. This mental illness is also characterised by cognitive alterations in various fields, including social cognition difficulties and self / non-self-discrimination difficulties. Self and non-self-discrimination abilities have been regrouped under a function called source memory. This source memory enables a person to identify the source of an information previously encoded. In our everyday life, these processes are necessary to distinguish events generated by an external source from imagined events. It is called reality monitoring. A number of studies have evidenced reality-monitoring alterations in patients suffering from schizophrenia. More specifically, patients would present with an externalisation bias, they would assign more imagined events to an external source. The knowledge of these deficits encourages the study of the processes involved in order to better understand the alterations, particularly including auditory processes. A recent study has shown that discrimination errors concerning certain sound characteristics (e.g. frequency) were associated to reality monitoring errors. However, the links between reality-monitoring and basic auditory processes have rarely been explored. The dysfunction of the auditory "where" path, especially the possibility to discriminate between the intra and extra cephalic localisation of sounds, could lead to difficulties to discern between what is produced by one self and what is produced by another or the local environment.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

February 9, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 24, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

March 31, 2021

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

March 24, 2022

Status Verified

March 1, 2022

Enrollment Period

2.4 years

First QC Date

February 9, 2021

Last Update Submit

March 23, 2022

Conditions

Keywords

auditory processesemotional perceptionsource monitoringschizophrenia

Outcome Measures

Primary Outcomes (1)

  • Performance on a Reality monitoring task and on an externalization task

    A computerized source memory task was designed for this study and a computerized externalization task was also designed (see description above). Rate of correct responses in both tasks is the main outcome.

    one day

Secondary Outcomes (3)

  • Performance on a task measuring the impact of emotional stimuli on externalization processes

    one day

  • Performance on source separating paradigms

    one day

  • Performance on basic auditory tasks

    one day

Study Arms (2)

Patient group with schizophrenia

ACTIVE COMPARATOR

The schizophrenic subjects will undertake a 3 hour session of cognitive experiments. Tasks will include a battery of psychoacoustic tests, a source monitoring task, an externalization task, a pitch discrimination task and a speech-in-speech task.

Behavioral: cognitive experiments' session

Healthy control subjects

ACTIVE COMPARATOR

Healthy control subjects will undertake a 3 hour session of cognitive experiments. Tasks will include a battery of psychoacoustic tests, a source monitoring task, an externalization task, a pitch discrimination task and a speech-in-speech task.

Behavioral: cognitive experiments' session

Interventions

The aim of this unique session of cognitive experiments is to study the links between source memory deficits and externalization abilities in healthy control subjects. Results of this Arm 2 will be compared to those of Arm 1.

Healthy control subjectsPatient group with schizophrenia

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects aged between 18 and 65 years old - written given consent
  • For patients with schizophrenia:
  • \- that meet the DSM-5.0 schizophrenia criteria
  • For healthy control subjects:
  • absence of psychiatric disroders (past and actual) diagnosed according to the DSM-5.0
  • absence of prodromal psychosis as measured by a score under 6 at the Prodromal Questionnaire PQ-16 (Ising et al., 2012)
  • absence of auditory disorders (actual and past) (including tinnitus)
  • absence of medical treatment (to the exception of contraceptive pills

You may not qualify if:

  • history of neurological disorders or brain injury with loss of consciousness
  • subjects presenting with highly developed musical abilities (frequently practicing a musical instrument)
  • subjects presenting with an intellectual deficiency as measured by the Raven progressive matrices
  • subjects under guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier le Vinatier

Bron, 69678, France

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2021

First Posted

February 24, 2021

Study Start

March 31, 2021

Primary Completion

September 1, 2023

Study Completion

September 1, 2024

Last Updated

March 24, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations