Functional Correlates of Bipolar Disorders and Effects of the Psychoeducation. an fMRI Study
BIP-ED
2 other identifiers
interventional
45
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2011
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 6, 2012
CompletedFirst Posted
Study publicly available on registry
April 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedJanuary 28, 2014
January 1, 2014
2.6 years
November 6, 2012
January 27, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
measurements were performed at T1 and T2 (up to 3 months)
Study Arms (1)
psychoeducation
EXPERIMENTALpsychoeducation (12 weeks)
Interventions
Bipolar disorders are educated to learn about their pathology
Eligibility Criteria
You may qualify if:
- clinical diagnosis of bipolar disorders
- euthymic (Montgomery and Asberg depression rating scale \< 10, Young Mania rating scale \< 10)
You may not qualify if:
- other concomitant psychiatric disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ums Irmage
Grenoble, 38000, France
Related Publications (1)
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.
PMID: 26244883DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thierry Bougerol, professor
CHU grenoble pôle psychiatrie et neurologie
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 6, 2012
First Posted
April 1, 2013
Study Start
May 1, 2011
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
January 28, 2014
Record last verified: 2014-01