Back to resultsLinks Between Perception of Temporal Order Judgment and Causality in Schizophrenia (TOCAS)
Primary Purpose
Schizophrenia
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Performances of patients and controls on temporal task
Sponsored by
About this trial
This is an interventional other trial for Schizophrenia
Eligibility Criteria
Inclusion Criteria:
Subjects with schizophrenia:
- Age from 18 to 45 years
- Diagnosis of schizophrenia according to DSM V criteria
- French mother tongue
- Psychotropic treatment unchanged during the month preceding the inclusion
- Stable symptomatology
- Normal or corrected visual acuity (> 0.8 at Snellen scale) and normal color vision
- Patients who gave informed consent to participate in the study
Control subjects (healthy volunteers):
- Age from 18 to 45 years
- Absence of neurological and psychiatric disorders
- French mother tongue
Exclusion Criteria:
- Recent addiction and abuse of cannabis or any other substance (according to DSM V criteria)
- Neurological disorders of vascular, infectious or neurodegenerative origin
- Taking somatic drugs with a cerebral or mental impact (eg corticosteroids)
- Disabling sensory disturbances, and in particular visual acuity
- Participation in a Neuro Cognitive Remediation Program
- Schizophrenia resistant to neuroleptic treatments
- Persons protected by law (pregnant women, minors, major under guardianship ...)
Sites / Locations
- Vial VeroniqueRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
subjects with schizophrenia
healthy subjects
Arm Description
Performances on temporal task Subjective alterations of time perception in patients with an adapted scale (EAWE) Global symptomatology with PANSS (positive and negative symptom scale)
Evaluate the links (correlation) between perception of temporal sequencing and perception of causality using an adapted experimental paradigm (Michotte paradigm) and to compare performance between healthy subjects and controls Investigate the existence of a correlation between these alterations and the peculiarities of the subjective experience of time (EAWE scale) in the group of subjects with schizophrenia
Outcomes
Primary Outcome Measures
Comparison of the scores obtained by subjects with schizophrenia vs. the controls for the causal tasks, according to the delays between stimuli (stopping the moving launcher and appearance of the static object).
Michotte paradigm: evaluate the links (correlation) between perception of temporal sequencing and perception of causality using an adapted experimental paradigm
Secondary Outcome Measures
Comparisons of the scores obtained on the Time Experiment Rating Examination of Anomalous World Experience Scale (EAWE).
Examination of Anomalous World Experience (EAWE ) scale:investigate the existence of a correlation between these alterations and the peculiarities of the subjective experience of time The E.A.W.E. consists of 6 dimensions (relation to space / relation to time / relation to others / language / atmospheric experience / existential orientation).The second domain only will be explored in our study Each item is both detailed, on a scale of 0 to 2 (0 for absent, 1 for present but with doubt, 2 for present, no doubt). The overall score of the sub-time scale thus ranges between 0 and 78.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03432000
Brief Title
Links Between Perception of Temporal Order Judgment and Causality in Schizophrenia
Acronym
TOCAS
Official Title
Study of the Links Between Perception of Temporal Order Judgment and Causality in Schizophrenic Spectrum Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hôpital le Vinatier
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
People with schizophrenia show disturbances in the perception of time. Among these alterations are the perturbations of the temporal order judgment. They are characterized by the fact that, as opposed to the general population, people with schizophrenia require a longer time interval between two successive stimuli to estimate which of the two events appeared first. If these alterations are now well documented, their consequences remain little explored. Among these consequences could however appear distortions of the judgment of causality (likely to underlie certain delusional interpretations) as well as a distressing experience of loss of the continuity of the lived experience (that could contribute to the alterations basic of self-awareness).
Detailed Description
The objective of our work lies in the study of the links between temporal sequencing, subjective perception of time and causality.
To carry out this work, the investigators will rely on an experimental paradigm (derived from Michotte's paradigm) which makes it possible to explore the links between temporal sequencing and perception of causality, validated in the normal subject. subjective consequences of these alterations will be explored using a phenomenological-inspired clinical scale (EAWE time-scale items)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study consists in:
evaluate the links (correlation) between perception of temporal sequencing and perception of causality using an adapted experimental paradigm (Michotte paradigm) and to compare performance between healthy subjects and controls
investigate the existence of a correlation between these alterations and the peculiarities of the subjective experience of time (EAWE scale) in the group of subjects with schizophrenia
The measures that will be realized are:
Performances of patients and controls on temporal task
Subjective alterations of time perception in patients with an adapted scale (EAWE)
Global symptomatology with PANSS (positive and negative symptom scale)
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
subjects with schizophrenia
Arm Type
Experimental
Arm Description
Performances on temporal task Subjective alterations of time perception in patients with an adapted scale (EAWE) Global symptomatology with PANSS (positive and negative symptom scale)
Arm Title
healthy subjects
Arm Type
Sham Comparator
Arm Description
Evaluate the links (correlation) between perception of temporal sequencing and perception of causality using an adapted experimental paradigm (Michotte paradigm) and to compare performance between healthy subjects and controls Investigate the existence of a correlation between these alterations and the peculiarities of the subjective experience of time (EAWE scale) in the group of subjects with schizophrenia
Intervention Type
Other
Intervention Name(s)
Performances of patients and controls on temporal task
Intervention Description
To carry out this work, we will rely on an experimental paradigm (derived from Michotte's paradigm) which makes it possible to explore the links between temporal sequencing and perception of causality, validated in the normal subject. subjective consequences of these alterations will be explored using a phenomenological-inspired clinical scale (EAWE time-scale items)
Primary Outcome Measure Information:
Title
Comparison of the scores obtained by subjects with schizophrenia vs. the controls for the causal tasks, according to the delays between stimuli (stopping the moving launcher and appearance of the static object).
Description
Michotte paradigm: evaluate the links (correlation) between perception of temporal sequencing and perception of causality using an adapted experimental paradigm
Time Frame
eight months
Secondary Outcome Measure Information:
Title
Comparisons of the scores obtained on the Time Experiment Rating Examination of Anomalous World Experience Scale (EAWE).
Description
Examination of Anomalous World Experience (EAWE ) scale:investigate the existence of a correlation between these alterations and the peculiarities of the subjective experience of time The E.A.W.E. consists of 6 dimensions (relation to space / relation to time / relation to others / language / atmospheric experience / existential orientation).The second domain only will be explored in our study Each item is both detailed, on a scale of 0 to 2 (0 for absent, 1 for present but with doubt, 2 for present, no doubt). The overall score of the sub-time scale thus ranges between 0 and 78.
Time Frame
eight months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects with schizophrenia:
Age from 18 to 45 years
Diagnosis of schizophrenia according to DSM V criteria
French mother tongue
Psychotropic treatment unchanged during the month preceding the inclusion
Stable symptomatology
Normal or corrected visual acuity (> 0.8 at Snellen scale) and normal color vision
Patients who gave informed consent to participate in the study
Control subjects (healthy volunteers):
Age from 18 to 45 years
Absence of neurological and psychiatric disorders
French mother tongue
Exclusion Criteria:
Recent addiction and abuse of cannabis or any other substance (according to DSM V criteria)
Neurological disorders of vascular, infectious or neurodegenerative origin
Taking somatic drugs with a cerebral or mental impact (eg corticosteroids)
Disabling sensory disturbances, and in particular visual acuity
Participation in a Neuro Cognitive Remediation Program
Schizophrenia resistant to neuroleptic treatments
Persons protected by law (pregnant women, minors, major under guardianship ...)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
MARTIN MD BRICE, PH
Phone
0033426738533
Email
brice.martin@ch-le-vinatier.fr
First Name & Middle Initial & Last Name or Official Title & Degree
VIAL VERONIQUE
Phone
0033437915531
Email
veronique.vial@ch-le-vinatier.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MARTIN BRICE
Organizational Affiliation
CH LE VINATIER
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vial Veronique
City
Bron
State/Province
Rhone Alpes
ZIP/Postal Code
69678
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MARTIN MD BRICE, PH
Phone
0033426738535
Email
brice.martin@ch-le-vinatier.fr
First Name & Middle Initial & Last Name & Degree
PH
12. IPD Sharing Statement
Plan to Share IPD
No
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Links Between Perception of Temporal Order Judgment and Causality in Schizophrenia
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