- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02765880
Time,Self and Spontaneous Mental Activities in Patients With Psychotic Disorders (Self and Time)
August 18, 2025 updated by: University Hospital, Strasbourg, France
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
84
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Strasbourg, France, 67000
- Service de psychiatrie
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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: Healthy volunteer
|
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.
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.
|
|
Experimental: Patients with schizophrenia
|
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.
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.
|
|
Experimental: Patient with bipolar disorder
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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)
|
After study completion (2 years)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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)
|
After study completion (2 years)
|
|
- 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)
|
After study completion (2 years)
|
|
Comparison of patients with schizophrenia vs. bipolar disorder
Time Frame: During fMRI and EEG sessions
|
During fMRI and EEG sessions
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Anne GIERSCH, Strasbourg's University Hospitals - INSERM 1114 Unit
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 16, 2017
Primary Completion (Actual)
July 1, 2025
Study Completion (Actual)
July 1, 2025
Study Registration Dates
First Submitted
April 15, 2016
First Submitted That Met QC Criteria
May 6, 2016
First Posted (Estimated)
May 9, 2016
Study Record Updates
Last Update Posted (Actual)
August 19, 2025
Last Update Submitted That Met QC Criteria
August 18, 2025
Last Verified
August 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6366
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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