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

Sponsor

University Hospital, Grenoble (Other)

Overall Status

Completed

CT.gov ID

NCT01821469

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

1.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Conditions Influencing Health Status Bipolar Disorders	Behavioral: psychoeducation	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

45 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Functional Correlates of Bipolar Disorders and Effects of the Psychoeducation. Assessment by Functional and Anatomic Neuroimaging.

Study Start Date :

May 1, 2011

Actual Primary Completion Date :

Dec 1, 2013

Actual Study Completion Date :

Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: psychoeducation psychoeducation (12 weeks)	Behavioral: psychoeducation Bipolar disorders are educated to learn about their pathology

Arm

Intervention/Treatment

Experimental: psychoeducation

psychoeducation (12 weeks)

Behavioral: psychoeducation

Bipolar disorders are educated to learn about their pathology

Outcome Measures

Primary Outcome Measures

fMRI measurement (neurophysiological [fMRI - activation and functional connectivity]) [measurements were performed at T1 and T2 (up to 3 months)]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ums Irmage	Grenoble		France	38000

Sponsors and Collaborators

University Hospital, Grenoble

Investigators

Principal Investigator: Thierry Bougerol, professor, CHU grenoble pôle psychiatrie et neurologie

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

AdministrateurDRC, Professor, University Hospital, Grenoble

ClinicalTrials.gov Identifier:

NCT01821469

Other Study ID Numbers:

EssaiClinique_"BIP-ED"
2011-A00425-36

First Posted:

Apr 1, 2013

Last Update Posted:

Jan 28, 2014

Last Verified:

Jan 1, 2014

Keywords provided by AdministrateurDRC, Professor, University Hospital, Grenoble

bipolar disorders

euthymic

psychotherapy

Functional magnetic resonance imaging

Additional relevant MeSH terms:

Disease

Bipolar Disorder

Study Results

No Results Posted as of Jan 28, 2014