Time,Self and Spontaneous Mental Activities in Patients With Psychotic Disorders

Schizophrenia Clinical Trial

— Self and Time  

Official title:

Time,Self and Spontaneous Mental Activities in Patients With Psychotic Disorders

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02765880
• Other study ID #: 6366
• Status: Recruiting
• Phase: N/A
• Start date: March 16, 2017
• Est. completion date: September 2025

Study information

• Verified date: August 2023
• Source: University Hospital, Strasbourg, France
• Contact: Anne Laudamy
• Phone: +33 3 88 11 66 88
• Email: anne.laudamy[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 161
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Disorder
• Mental Disorders
• Psychotic Disorders
• Schizophrenia

Intervention

Other:
• fMRI
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.
• EEG
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.

Locations

Country	Name	City	State
France	Service de psychiatrie	Strasbourg

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France	Fondation pour la Recherche Médicale (FRM)

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		After study completion (2 years)
Secondary	Evaluation of the brain' functional coupling dynamics over time (how neuronal networks and connectivity change over time) during rest.		After study completion (2 years)
Secondary	- Evaluation of the brain' functional coupling dynamics over time (how neuronal networks and connectivity change over time) during time ordering.		After study completion (2 years)
Secondary	Comparison of patients with schizophrenia vs. bipolar disorder		During fMRI and EEG sessions