Back to resultsTime,Self and Spontaneous Mental Activities in Patients With Psychotic Disorders (Self and Time)
Primary Purpose
Schizophrenia, Bipolar Disorder
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
fMRI
EEG
Sponsored by
About this trial
This is an interventional other trial for Schizophrenia
Eligibility Criteria
Inclusion Criteria:
- Age between 18 and 60 years
- Affiliation to a social security insurance
- Written consent given
- Only for patient : DSM criteria for schizophrenia or bipolar disorder
Exclusion Criteria:
- Addiction problem
- Invalidating visual sensory problems
- Neurological history
- Pregnancy or breastfeeding
- Legal safeguard
- Participation in another clinical trial
- Contraindication to MRI
Sites / Locations
- Service de psychiatrieRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Healthy volunteer
Patients with schizophrenia
Patient with bipolar disorder
Arm Description
Outcomes
Primary Outcome Measures
Abnormalities in connectivity during order judgement tasks will be taken as seeds to check whether they account for abnormalities in connectivity at rest, by means of mathematic modelization
Secondary Outcome Measures
Evaluation of the brain' functional coupling dynamics over time (how neuronal networks and connectivity change over time) during rest.
- Evaluation of the brain' functional coupling dynamics over time (how neuronal networks and connectivity change over time) during time ordering.
Comparison of patients with schizophrenia vs. bipolar disorder
Full Information
NCT ID
NCT02765880
First Posted
April 15, 2016
Last Updated
August 18, 2023
Sponsor
University Hospital, Strasbourg, France
Collaborators
Fondation pour la Recherche Médicale (FRM)
1. Study Identification
Unique Protocol Identification Number
NCT02765880
Brief Title
Time,Self and Spontaneous Mental Activities in Patients With Psychotic Disorders
Acronym
Self and Time
Official Title
Time,Self and Spontaneous Mental Activities in Patients With Psychotic Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 16, 2017 (Actual)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
September 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France
Collaborators
Fondation pour la Recherche Médicale (FRM)
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
The main purpose of the study is to examine to which extent abnormalities in the dynamics of neural activities observed in patients with psychosis is related to difficulties at ordering simple visual stimuli and/or personal events.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Bipolar Disorder
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
161 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Healthy volunteer
Arm Type
Experimental
Arm Title
Patients with schizophrenia
Arm Type
Experimental
Arm Title
Patient with bipolar disorder
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
fMRI
Intervention Description
Connectivity between the areas related to information processing over time and the areas activated during the rest activity. We will verify whether the activation anomalies observed during time tasks predict anomalies in spontaneous activity dynamics.
Intervention Type
Other
Intervention Name(s)
EEG
Intervention Description
link between EEG response anomalies related to information processing over time and response anomalies recorded during rest activity. We will check whether anomalies in EEG oscillatory responses during time tasks predict anomalies during the rest task.
Primary Outcome Measure Information:
Title
Abnormalities in connectivity during order judgement tasks will be taken as seeds to check whether they account for abnormalities in connectivity at rest, by means of mathematic modelization
Time Frame
After study completion (2 years)
Secondary Outcome Measure Information:
Title
Evaluation of the brain' functional coupling dynamics over time (how neuronal networks and connectivity change over time) during rest.
Time Frame
After study completion (2 years)
Title
- Evaluation of the brain' functional coupling dynamics over time (how neuronal networks and connectivity change over time) during time ordering.
Time Frame
After study completion (2 years)
Title
Comparison of patients with schizophrenia vs. bipolar disorder
Time Frame
During fMRI and EEG sessions
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age between 18 and 60 years
Affiliation to a social security insurance
Written consent given
Only for patient : DSM criteria for schizophrenia or bipolar disorder
Exclusion Criteria:
Addiction problem
Invalidating visual sensory problems
Neurological history
Pregnancy or breastfeeding
Legal safeguard
Participation in another clinical trial
Contraindication to MRI
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anne Laudamy
Phone
+33 3 88 11 66 88
Email
anne.laudamy@chru-strasbourg.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne GIERSCH
Organizational Affiliation
Strasbourg's University Hospitals - INSERM 1114 Unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de psychiatrie
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Giersch, MD
12. IPD Sharing Statement
Learn more about this trial
Time,Self and Spontaneous Mental Activities in Patients With Psychotic Disorders
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