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Active, not recruiting Not applicable

Shared Medical Decision Making in the Prophylactic Treatment of Bipolar Disorder

NCT03245593 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2018-04-24
Last updated
2025-12-18

Condition(s) studied

Bipolar Disorder

Investigational drug(s) / intervention(s)

Shared-decision making processstandard care

Shared-decision making process: Completion of the Ottawa Personal Decision Guide to help guide care with the support of online and printed material describing the therapeutic options available

standard care: Care of patients according to standard practice of managing patients with bipolar disorder

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * The patient must have given their free and informed consent and signed the consent form * 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-5 criteria) 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 participating centers * Without comprehension problems of fluent French Exclusion Criteria: * The subject is participating in an interventional study, or has participated in another 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 to sign the consent * The subject has already participated in this study * The patient has troubles linked to the usage of severe intensive substances (such as those defined by the DMS-5) * The patient has a revision of the initial diagnosis of bipolar disorder

Primary outcome measure(s)

  • Measure the difference of prophylactic treatment compliance between bipolar patients receiving treatment according to standard care versus a shared decision making care plan following a mood episode. — 12 months
    Clinician Rating Scale (1-7)

Trial sites (16)

FacilityCityRegionStatus
Ch Beziers Béziers France
CH Charles Perrens Bordeaux France
CH le Vinatier Bron France
CHU de Clermont Ferrand - Hôpital Gabriel-Montpied Clermont-Ferrand France
Chu Gabriel Montpied Clermont Ferrand Clermont-Ferrand France
CH Sainte-Marie de Clermont-Ferrand Clermont-Ferrand France
APHP - Centre Hospitalier Henri Mondor Créteil France
CHU de Grenoble - Hôpital Albert Michallon Grenoble France
CH Limoges Limoges France
APHM - Hôpital Sainte-Marguerite Marseille France
CHU de Montpellier - Hôpital Lapeyronie Montpellier France
CHU Nancy Nancy France
CHU Nantes Nantes France
Clinique des troubles thymiques Nîmes France
CHU Nimes Nîmes France
APHP - Hôpital Saint Louis-Lariboisière-Fernand-Widal Paris France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03245593 on ClinicalTrials.gov ↗ ← All trials in France