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

NCT02765880 | Terminated

• 1 other identifier: 6366
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Evaluation of the brain' functional coupling dynamics over time (how neuronal networks and connectivity change over time) during rest.

  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.

  After study completion (2 years)

• Comparison of patients with schizophrenia vs. bipolar disorder

  During fMRI and EEG sessions

Study Arms (3)

Healthy volunteer

EXPERIMENTAL

Other: fMRI; Other: EEG

Patients with schizophrenia

EXPERIMENTAL

Other: fMRI; Other: EEG

Patient with bipolar disorder

EXPERIMENTAL

Other: fMRI; Other: EEG

Interventions

fMRI OTHER

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.

Healthy volunteer; Patient with bipolar disorder; Patients with schizophrenia

EEG OTHER

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.

Healthy volunteer; Patient with bipolar disorder; Patients with schizophrenia

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Addiction problem
• Invalidating visual sensory problems
• Neurological history
• Pregnancy or breastfeeding
• Legal safeguard
• Participation in another clinical trial
• Contraindication to MRI

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead
• Fondation pour la Recherche Médicale (FRM): collaborator

Study Sites (1)

Service de psychiatrie

Strasbourg, 67000, France

Location

MeSH Terms

Conditions

Schizophrenia; Bipolar Disorder

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Bipolar and Related Disorders; Mood Disorders

Study Officials

• Anne GIERSCH

  Strasbourg's University Hospitals - INSERM 1114 Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2016
• First Posted: May 9, 2016
• Study Start: March 16, 2017
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: August 19, 2025

Record last verified: 2025-08

Locations

FR (1)