Status:
ACTIVE_NOT_RECRUITING
Shared Medical Decision Making in the Prophylactic Treatment of Bipolar Disorder
Lead Sponsor:
Centre Hospitalier Universitaire de Nīmes
Conditions:
Bipolar Disorder
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 patien...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 24 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT03245593
Start Date
April 24 2018
End Date
December 1 2025
Last Update
December 18 2025
Active Locations (16)
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1
Ch Beziers
Béziers, France, 34500
2
CH Charles Perrens
Bordeaux, France, 33076
3
CH le Vinatier
Bron, France, 69678
4
CHU de Clermont Ferrand - Hôpital Gabriel-Montpied
Clermont-Ferrand, France, 63003