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fMRI of Flight of Ideas in Bipolar Disorder (i-TCP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02794129
Recruitment Status : Completed
First Posted : June 8, 2016
Last Update Posted : April 10, 2019
Sponsor:
Information provided by (Responsible Party):
CHU de Reims

Brief Summary:
Bipolar disorder is a mental disease characterized by mood dysregulation and arises from manic, depressive or mixed episodes. The observations of the patient's speech and language behaviour due to flight of ideas or loss of goal probably result from an underlying disturbance in semantic networks dealing with semantic associations. The aim of our study will be to have a better comprehension of thought disorders in bipolar disorder by cognitive exploration of semantic processing.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Other: Functional Magnetic Resonance Imaging Not Applicable

Detailed Description:
Bipolar disorder is a mental disease characterized by mood dysregulation and arises from manic, depressive or mixed episodes. During these episodes, formal thought disorders are observed, associated to emotional perturbation, behaviour troubles and some psychotic symptoms. During mania, the type of thought disorders observed are derailment, flight of ideas, with an increase in the amount of spontaneous speech and loss of goal. These observations of the patient's speech and language behaviour probably result from an underlying disturbance in semantic networks dealing with semantic associations. These networks have been studied extensively in schizophrenia but remain unknown in bipolar disorder. In this context, the aim of our study will be to have a better comprehension of formal thought disorders in bipolar disorder by cognitive exploration of semantic activation and inhibition.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Functional Magnetic Resonance Imaging of Formal Thought Disorders in Bipolar Disorder
Actual Study Start Date : August 2013
Actual Primary Completion Date : April 2018
Actual Study Completion Date : September 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Bipolar Disorder patients Other: Functional Magnetic Resonance Imaging
Experimental: Healthy Controls Other: Functional Magnetic Resonance Imaging



Primary Outcome Measures :
  1. brain activation profiles by Functional Magnetic Resonance Imaging [ Time Frame: inclusion visit ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria

BD patients :

  • Men or women, right-handed
  • diagnosis of type 1 bipolar disorder, according to the DSM-IV criteria
  • aged from 18 to 65 years-old
  • Native French speaker
  • Affiliated to the social security

Healthy Controls (HC):

  • Men or women, right-handed
  • aged from 18 to 65 years-old
  • Native French speaker
  • Affiliated to the social security

Exclusion criteria

BD patients :

  • recent alcohol and/or drug abuse or dependence
  • significant general medical illness, including neurological disorders or head trauma
  • sensorial impairment (visual and/or hearing)
  • Contraindication to the use of MRI

HC:

  • first-degree-relative history of bipolar disorder, schizophrenia or schizoaffective disorder according to DSM-IV
  • recent alcohol and/or drug abuse or dependence
  • significant general medical illness, including neurological disorders or head trauma
  • sensorial impairment (visual and/or hearing)
  • Contraindication to the use of 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): NCT02794129


Locations
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France
Chu Reims
Reims, France, 51092
Sponsors and Collaborators
CHU de Reims
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Responsible Party: CHU de Reims
ClinicalTrials.gov Identifier: NCT02794129    
Other Study ID Numbers: PJ12075
First Posted: June 8, 2016    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: May 2016
Additional relevant MeSH terms:
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Disease
Bipolar Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders