Shared Medical Decision Making in the Prophylactic Treatment of Bipolar Disorder

Last updated: February 11, 2025
Sponsor: Centre Hospitalier Universitaire de Nīmes
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Mood Disorders

Bipolar Disorder

Treatment

Shared-decision making process

standard care

Clinical Study ID

NCT03245593
PREPS/2016/LS-01
  • Ages > 18
  • All Genders

Study Summary

The investigators hypothesize that implementation of a shared decision making care plan for prophylactic treatment will help therapeutic adherence of bipolar patients. They also anticipate that patients treated according to a shared decision making plan will have an elevated satisfaction of their care, quality of life and functionment, as well as a lower number of relapses

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • The patient must have given their free and informed consent and signed the consentform

  • The patient must be a member or beneficiary of a health insurance plan

  • The patient must be available for the 12 months of follow-up

  • The patient is at least 18 years old

  • Patients is suffering from bipolar disorder (I or II) according to DSM-5 criteria

  • Following resolution of a mood episode (manic or depressive according to DSM-5criteria) according to the criteria of l'International Society for Bipolar Disorder (Recovery, clinical remission of at least 4 weeks)

  • Followed by at least one of the practitioner belonging to one of the participatingcenters

  • Without comprehension problems of fluent French

Exclusion

Exclusion Criteria:

  • The subject is participating in an interventional study, or has participated inanother interventional study within the previous 3 months

  • The subject is in a period of exclusion determined by a previous study

  • The patient is under safeguard of justice or state guardianship

  • It is impossible to give the subject informed information, or the subject refuses tosign the consent

  • The subject has already participated in this study

  • The patient has troubles linked to the usage of severe intensive substances (such asthose defined by the DMS-5)

  • The patient has a revision of the initial diagnosis of bipolar disorder

Study Design

Total Participants: 300
Treatment Group(s): 2
Primary Treatment: Shared-decision making process
Phase:
Study Start date:
April 24, 2018
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Ch Beziers

    Beziers, 34500
    France

    Site Not Available

  • CH Charles Perrens

    Bordeaux, 33076
    France

    Site Not Available

  • CH le Vinatier

    Bron, 69678
    France

    Site Not Available

  • Chu Gabriel Montpied Clermont Ferrand

    Clermont Ferrand, 63003
    France

    Site Not Available

  • CH Sainte-Marie de Clermont-Ferrand

    Clermont-Ferrand, 63037
    France

    Site Not Available

  • CHU de Clermont Ferrand - Hôpital Gabriel-Montpied

    Clermont-Ferrand, 63003
    France

    Site Not Available

  • APHP - Centre Hospitalier Henri Mondor

    Créteil, 94010
    France

    Site Not Available

  • CHU de Grenoble - Hôpital Albert Michallon

    Grenoble, 38043
    France

    Site Not Available

  • CH Limoges

    Limoges, 87025
    France

    Site Not Available

  • APHM - Hôpital Sainte-Marguerite

    Marseille, 13274
    France

    Site Not Available

  • CHU de Montpellier - Hôpital Lapeyronie

    Montpellier, 34295
    France

    Site Not Available

  • CHU Nancy

    Nancy, 54000
    France

    Site Not Available

  • CHU Nantes

    Nantes, 44000
    France

    Site Not Available

  • CHU Nimes

    Nîmes, 30029
    France

    Site Not Available

  • Clinique des troubles thymiques

    Nîmes, 30000
    France

    Site Not Available

  • APHP - Hôpital Saint Louis-Lariboisière-Fernand-Widal

    Paris, 75475
    France

    Site Not Available

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