Back to resultsfMRI of Flight of Ideas in Bipolar Disorder (i-TCP)
Primary Purpose
Bipolar Disorder
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Functional Magnetic Resonance Imaging
Sponsored by
About this trial
This is an interventional other trial for Bipolar Disorder
Eligibility 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
Sites / Locations
- Chu Reims
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Bipolar Disorder patients
Healthy Controls
Arm Description
Outcomes
Primary Outcome Measures
brain activation profiles by Functional Magnetic Resonance Imaging
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02794129
Brief Title
fMRI of Flight of Ideas in Bipolar Disorder
Acronym
i-TCP
Official Title
Functional Magnetic Resonance Imaging of Formal Thought Disorders in Bipolar Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
August 2013 (Actual)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
September 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHU de Reims
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
79 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bipolar Disorder patients
Arm Type
Experimental
Arm Title
Healthy Controls
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Functional Magnetic Resonance Imaging
Primary Outcome Measure Information:
Title
brain activation profiles by Functional Magnetic Resonance Imaging
Time Frame
inclusion visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Chu Reims
City
Reims
ZIP/Postal Code
51092
Country
France
12. IPD Sharing Statement
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fMRI of Flight of Ideas in Bipolar Disorder
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