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

Bipolar Disorders Clinical Trial

— BIP-ED  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01821469
• Other study ID #: EssaiClinique_"BIP-ED"
• Secondary ID: 2011-A00425-36
• Status: Completed
• Phase: N/A
• First received: November 6, 2012
• Last updated: January 27, 2014
• Start date: May 2011
• Est. completion date: December 2013

Study information

• Verified date: January 2014
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of PersonnesFrance: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder
• Bipolar Disorders
• Conditions Influencing Health Status

Intervention

Behavioral:
• psychoeducation
Bipolar disorders are educated to learn about their pathology

Locations

Country	Name	City	State
France	Ums Irmage	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes