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Completed

NCT Number: NCT01821469

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

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.

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Key information

Conditions

Conditions Influencing Health Status Bipolar Disorder Bipolar Disorders Bipolar and Related Disorders Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ums Irmage

Grenoble, 38000, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Psychoeducation

Behavioral

Bipolar disorders are educated to learn about their pathology

Primary outcomes

  1. fMRI measurement (neurophysiological [fMRI - activation and functional connectivity])

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

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

Acronym: BIP-ED

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Apr 1, 2013
Registry last updated
Jan 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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