- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03432000
Links Between Perception of Temporal Order Judgment and Causality in Schizophrenia (TOCAS)
Study of the Links Between Perception of Temporal Order Judgment and Causality in Schizophrenic Spectrum Disorders
Study Overview
Status
Conditions
Intervention / Treatment
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)
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Rhone Alpes
-
Bron, Rhone Alpes, France, 69678
- Vial Veronique
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 ...)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: subjects with schizophrenia
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)
|
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)
|
|
Sham Comparator: healthy subjects
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
|
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
Time Frame: eight months
|
Michotte paradigm: evaluate the links (correlation) between perception of temporal sequencing and perception of causality using an adapted experimental paradigm
|
eight months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comparisons of the scores obtained on the Time Experiment Rating Examination of Anomalous World Experience Scale (EAWE).
Time Frame: eight months
|
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.
|
eight months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: MARTIN BRICE, CH Le Vinatier
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-A03019-44
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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