i-TCP: fMRI of Flight of Ideas in Bipolar Disorder

Sponsor

CHU de Reims (Other)

Overall Status

Completed

CT.gov ID

NCT02794129

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

1.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Bipolar Disorder	Other: Functional Magnetic Resonance Imaging	N/A

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.

Study Design

Study Type:

Interventional

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 :

Aug 1, 2013

Actual Primary Completion Date :

Apr 1, 2018

Actual Study Completion Date :

Sep 1, 2018

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Bipolar Disorder patients

Other: Functional Magnetic Resonance Imaging

Experimental: Healthy Controls

Other: Functional Magnetic Resonance Imaging

Outcome Measures

Primary Outcome Measures

brain activation profiles by Functional Magnetic Resonance Imaging [inclusion visit]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chu Reims	Reims		France	51092

Sponsors and Collaborators

CHU de Reims

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

CHU de Reims

ClinicalTrials.gov Identifier:

NCT02794129

Other Study ID Numbers:

PJ12075

First Posted:

Jun 8, 2016

Last Update Posted:

Apr 10, 2019

Last Verified:

May 1, 2016

Additional relevant MeSH terms:

Disease

Bipolar Disorder

Study Results

No Results Posted as of Apr 10, 2019