Study of the Links Between Perception of Temporal Order Judgment and Causality in Schizophrenic Spectrum Disorders

Links Between Perception of Temporal Order Judgment and Causality in Schizophrenia



Sponsors

Lead Sponsor



Source

Hôpital le Vinatier

Oversight Info

Has Dmc

No

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


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)

Overall Status

Recruiting

Start Date

2018-02-01

Completion Date

2018-12-30

Primary Completion Date

2018-12-30

Phase

N/A

Study Type

Interventional

Primary Outcome

Measure

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).
eight months

Secondary Outcome

Measure

Time Frame

Comparisons of the scores obtained on the Time Experiment Rating Examination of Anomalous World Experience Scale (EAWE).
eight months

Enrollment

60

Condition


Intervention

Intervention Type

Other

Intervention Name


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)

Arm Group Label

subjects with schizophrenia

healthy subjects



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 ...)

Gender

All

Minimum Age

18 Years

Maximum Age

45 Years

Healthy Volunteers

Accepts Healthy Volunteers


Overall Official

Last Name

Role

Affiliation

MARTIN BRICE
Principal Investigator
CH LE VINATIER

Overall Contact

Last Name

MARTIN MD BRICE, PH

Phone

0033426738533

Email



Location

Facility

Status

Contact

Vial Veronique
Bron Rhone Alpes 69678 France
Recruiting
Last Name: MARTIN MD BRICE, PH
Phone: 0033426738535
Email: [email protected]

Location Countries

Country

France


Verification Date

2018-02-01

Lastchanged Date

2018-02-13

Firstreceived Date

2018-02-07

Responsible Party

Responsible Party Type

Sponsor


Has Expanded Access

No

Condition Browse


Number Of Arms

2

Arm Group

Arm Group Label

subjects with schizophrenia

Arm Group Type

Experimental

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 Group Label

healthy subjects

Arm Group Type

Sham Comparator

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



Firstreceived Results Date

N/A

Overall Contact Backup

Last Name

VIAL VERONIQUE

Phone

0033437915531

Email



Acronym

TOCAS

Firstreceived Results Disposition Date

N/A

Study Design Info

Allocation

Non-Randomized

Intervention Model

Parallel Assignment

Intervention 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)

Primary Purpose

Other

Masking

None (Open Label)


Study First Submitted

February 7, 2018

Study First Submitted Qc

February 12, 2018

Study First Posted

February 13, 2018

Last Update Submitted

February 13, 2018

Last Update Submitted Qc

February 13, 2018

Last Update Posted

February 14, 2018


ClinicalTrials.gov processed this data on February 14, 2018

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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