search
Back to results

Functional Correlates of Bipolar Disorders and Effects of the Psychoeducation. an fMRI Study (BIP-ED)

Primary Purpose

Conditions Influencing Health Status, Bipolar Disorders

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
psychoeducation
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Conditions Influencing Health Status focused on measuring bipolar disorders, euthymic, psychotherapy, Functional magnetic resonance imaging

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • clinical diagnosis of bipolar disorders
  • euthymic (Montgomery and Asberg depression rating scale < 10, Young Mania rating scale < 10)

Exclusion Criteria:

  • other concomitant psychiatric disorders

Sites / Locations

  • Ums Irmage

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

psychoeducation

Arm Description

psychoeducation (12 weeks)

Outcomes

Primary Outcome Measures

fMRI measurement (neurophysiological [fMRI - activation and functional connectivity])
measurements were performed before (T1) and after (T2) educational program of 12 sessions .One session last one hour and half once a week (they come at the hospital for all sessions : i.e. during 12 weeks). Thus, T1 to T2 is 3 months (average).

Secondary Outcome Measures

Full Information

First Posted
November 6, 2012
Last Updated
January 27, 2014
Sponsor
University Hospital, Grenoble
search

1. Study Identification

Unique Protocol Identification Number
NCT01821469
Brief Title
Functional Correlates of Bipolar Disorders and Effects of the Psychoeducation. an fMRI Study
Acronym
BIP-ED
Official Title
Functional Correlates of Bipolar Disorders and Effects of the Psychoeducation. Assessment by Functional and Anatomic Neuroimaging.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Grenoble

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This research project follows two main objectives: 1) Assess anatomical and functional cerebral abnormalities in bipolar disorder. 2) Evaluate anatomical and functional changes after the application of a psychoeducational program in these patients. Specifically, this project aims to assess neurophysiological (fMRI - activation and functional connectivity) and neuroanatomical (morphometry and diffusion tensor imaging) specificities related to bipolar disorders and the therapeutic response to the psychoeducation. The results of this thesis project would also contribute to the validation of a pathophysiological model of the bipolar disorder.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Conditions Influencing Health Status, Bipolar Disorders
Keywords
bipolar disorders, euthymic, psychotherapy, Functional magnetic resonance imaging

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
psychoeducation
Arm Type
Experimental
Arm Description
psychoeducation (12 weeks)
Intervention Type
Behavioral
Intervention Name(s)
psychoeducation
Intervention Description
Bipolar disorders are educated to learn about their pathology
Primary Outcome Measure Information:
Title
fMRI measurement (neurophysiological [fMRI - activation and functional connectivity])
Description
measurements were performed before (T1) and after (T2) educational program of 12 sessions .One session last one hour and half once a week (they come at the hospital for all sessions : i.e. during 12 weeks). Thus, T1 to T2 is 3 months (average).
Time Frame
measurements were performed at T1 and T2 (up to 3 months)

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: clinical diagnosis of bipolar disorders euthymic (Montgomery and Asberg depression rating scale < 10, Young Mania rating scale < 10) Exclusion Criteria: other concomitant psychiatric disorders
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thierry Bougerol, professor
Organizational Affiliation
CHU grenoble pôle psychiatrie et neurologie
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ums Irmage
City
Grenoble
ZIP/Postal Code
38000
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
26244883
Citation
Favre P, Polosan M, Pichat C, Bougerol T, Baciu M. Cerebral Correlates of Abnormal Emotion Conflict Processing in Euthymic Bipolar Patients: A Functional MRI Study. PLoS One. 2015 Aug 5;10(8):e0134961. doi: 10.1371/journal.pone.0134961. eCollection 2015.
Results Reference
derived

Learn more about this trial

Functional Correlates of Bipolar Disorders and Effects of the Psychoeducation. an fMRI Study

We'll reach out to this number within 24 hrs