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

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ClinicalTrials.gov Identifier: NCT02765880
Recruitment Status : Not yet recruiting
First Posted : May 9, 2016
Last Update Posted : May 13, 2016
Sponsor:
Collaborator:
Fondation pour la Recherche Médicale (FRM)
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Bipolar Disorder Other: fMRI Other: EEG Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 161 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Time,Self and Spontaneous Mental Activities in Patients With Psychotic Disorders
Study Start Date : June 2016
Estimated Primary Completion Date : September 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Healthy volunteer Other: fMRI
Other: EEG
Experimental: Patients with schizophrenia Other: fMRI
Other: EEG
Experimental: Patient with bipolar disorder Other: fMRI
Other: EEG



Primary Outcome Measures :
  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 [ Time Frame: After study completion (2 years) ]

Secondary Outcome Measures :
  1. 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) ]
  2. - 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) ]
  3. Comparison of patients with schizophrenia vs. bipolar disorder [ Time Frame: During fMRI and EEG sessions ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02765880


Contacts
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Contact: Anne Laudamy +33 3 88 11 66 88 anne.laudamy@chru-strasbourg.fr
Contact: anatta Razafimanantsoa + 33 3 88 11 54 14 anatta.razafimanantsoa@chru-strasbourg.fr

Sponsors and Collaborators
University Hospital, Strasbourg, France
Fondation pour la Recherche Médicale (FRM)
Investigators
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Principal Investigator: Anne GIERSCH Strasbourg's University Hospitals - INSERM 1114 Unit

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Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT02765880     History of Changes
Other Study ID Numbers: 6366
First Posted: May 9, 2016    Key Record Dates
Last Update Posted: May 13, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
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Disease
Schizophrenia
Bipolar Disorder
Psychotic Disorders
Mental Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Bipolar and Related Disorders