Shared Medical Decision Making in the Prophylactic Treatment of Bipolar Disorder
NCT ID: NCT03245593
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
300 participants
INTERVENTIONAL
2018-04-24
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Shared Decision making for 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 decision making for care
standard care
Care of patients according to standard practice of managing patients with bipolar disorder
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire de Nīmes
OTHER
Responsible Party
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Principal Investigators
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Ludovic Samalin
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Clermont-Ferrand
Locations
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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
Countries
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References
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Samalin L, Honciuc M, Boyer L, de Chazeron I, Blanc O, Abbar M, Llorca PM. Efficacy of shared decision-making on treatment adherence of patients with bipolar disorder: a cluster randomized trial (ShareD-BD). BMC Psychiatry. 2018 Apr 13;18(1):103. doi: 10.1186/s12888-018-1686-y.
Other Identifiers
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PREPS/2016/LS-01
Identifier Type: -
Identifier Source: org_study_id