Shared Medical Decision Making in the Prophylactic Treatment of Bipolar Disorder (ShareD-BD)

December 11, 2025 updated by: Centre Hospitalier Universitaire de Nīmes
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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Bordeaux, France, 33076
        • CH Charles Perrens
      • Bron, France, 69678
        • CH Le Vinatier
      • Béziers, France, 34500
        • Ch Beziers
      • Clermont-Ferrand, France, 63003
        • CHU de Clermont Ferrand - Hôpital Gabriel-Montpied
      • Clermont-Ferrand, France, 63037
        • CH Sainte-Marie de Clermont-Ferrand
      • Clermont-Ferrand, France, 63003
        • Chu Gabriel Montpied Clermont Ferrand
      • Créteil, France, 94010
        • APHP - Centre Hospitalier Henri Mondor
      • Grenoble, France, 38043
        • CHU de Grenoble - Hopital Albert Michallon
      • Limoges, France, 87025
        • CH Limoges
      • Marseille, France, 13274
        • APHM - Hôpital Sainte-Marguerite
      • Montpellier, France, 34295
        • CHU de Montpellier - Hôpital Lapeyronie
      • Nancy, France, 54000
        • CHU Nancy
      • Nantes, France, 44000
        • CHU Nantes
      • Nîmes, France, 30029
        • CHU Nimes
      • Nîmes, France, 30000
        • Clinique des troubles thymiques
      • Paris, France, 75475
        • APHP - Hôpital Saint Louis-Lariboisière-Fernand-Widal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Study Population

Patients with biopolar disorder in consultation at one of the recruiting centers

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Shared Decision making for care
Other: 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
Other: Standard decision making for care
Other: standard care
Care of patients according to standard practice of managing patients with bipolar disorder

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 12 months
Clinician Rating Scale (1-7)
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Study the clinician-reported difference between the 2 groups in medication adherence
Time Frame: 3 months
Clinician Rating Scale (1-7)
3 months
Study the clinician-reported difference between the 2 groups in medication adherence
Time Frame: 6 months
Clinician Rating Scale (1-7)
6 months
Study the clinician-reported difference between the 2 groups in medication adherence
Time Frame: 9 months
Clinician Rating Scale (1-7)
9 months
Study the self-reported difference between the 2 groups in medication adherence
Time Frame: 3 months
Medication Adherence Rating Scale( 0-10),
3 months
Study the self-reported difference between the 2 groups in medication adherence
Time Frame: 6 months
Medication Adherence Rating Scale( 0-10),
6 months
Study the self-reported difference between the 2 groups in medication adherence
Time Frame: 9 months
Medication Adherence Rating Scale( 0-10),
9 months
Study the self-reported difference between the 2 groups in medication adherence
Time Frame: 12 months
Medication Adherence Rating Scale( 0-10),
12 months
Clinical evaluation of the difference between the 2 groups in medication adherence
Time Frame: 3 months
Plasma levels of medication for treatment of bipolar disorder, Lithium, anticonvulsants, second generation antipsychotics and antidepressants
3 months
Clinical evaluation of the difference between the 2 groups in medication adherence
Time Frame: 6 months
Plasma levels of medication for treatment of bipolar disorder, Lithium, anticonvulsants, second generation antipsychotics and antidepressants
6 months
Clinical evaluation of the difference between the 2 groups in medication adherence
Time Frame: 9 months
Plasma levels of medication for treatment of bipolar disorder, Lithium, anticonvulsants, second generation antipsychotics and antidepressants
9 months
Clinical evaluation of the difference between the 2 groups in medication adherence
Time Frame: 12 months
Plasma levels of medication for treatment of bipolar disorder, Lithium, anticonvulsants, second generation antipsychotics and antidepressants
12 months
Compare difference in the adherence to personalized follow-up between groups
Time Frame: 3 months
percentage of consultations missed
3 months
Compare difference in the adherence to personalized follow-up between groups
Time Frame: 6 months
percentage of consultations missed
6 months
Compare difference in the adherence to personalized follow-up between groups
Time Frame: 9 months
percentage of consultations missed
9 months
Compare difference in the adherence to personalized follow-up between groups
Time Frame: 12 months
percentage of consultations missed
12 months
Compare difference in patient perceptions related to the uncertainty of the medical decisions taken between groups
Time Frame: 3 months
decisional conflict scale (0-100)
3 months
Compare difference in patient perceptions related to the uncertainty of the medical decisions taken between groups
Time Frame: 6 months
decisional conflict scale (0-100)
6 months
Compare difference in patient perceptions related to the uncertainty of the medical decisions taken between groups
Time Frame: 9 months
decisional conflict scale (0-100)
9 months
Compare difference in patient perceptions related to the uncertainty of the medical decisions taken between groups
Time Frame: 12 months
decisional conflict scale (0-100)
12 months
Compare difference in patient satisfaction concerning the therapeutic decisions taken between groups
Time Frame: 3 months
adapted QSH-45: 3 questions scored 1-5
3 months
Compare difference in patient satisfaction concerning the therapeutic decisions taken between groups
Time Frame: 6 months
adapted QSH-45: 3 questions scored 1-5
6 months
Compare difference in patient satisfaction concerning the therapeutic decisions taken between groups
Time Frame: 9 months
adapted QSH-45: 3 questions scored 1-5
9 months
Compare difference in patient satisfaction concerning the therapeutic decisions taken between groups
Time Frame: 12 months
adapted QSH-45: 3 questions scored 1-5
12 months
Compare difference in patient satisfaction concerning the decision-making process between groups
Time Frame: 3 months
Adapted clinical decision making involvement and satisfaction score 3 questions scored 1-5
3 months
Compare difference in patient satisfaction concerning the decision-making process between groups
Time Frame: 6 months
Adapted clinical decision making involvement and satisfaction score 3 questions scored 1-5
6 months
Compare difference in patient satisfaction concerning the decision-making process between groups
Time Frame: 9 months
Adapted clinical decision making involvement and satisfaction score 3 questions scored 1-5
9 months
Compare difference in patient satisfaction concerning the decision-making process between groups
Time Frame: 12 months
Adapted clinical decision making involvement and satisfaction score 3 questions scored 1-5
12 months
Compare difference in therapeutic alliance between groups
Time Frame: 3 months
4-Point ordinal Alliance Scale
3 months
Compare difference in therapeutic alliance between groups
Time Frame: 6 months
4-Point ordinal Alliance Scale
6 months
Compare difference in therapeutic alliance between groups
Time Frame: 9 months
4-Point ordinal Alliance Scale
9 months
Compare difference in therapeutic alliance between groups
Time Frame: 12 months
4-Point ordinal Alliance Scale
12 months
Compare difference in knowledge of disease and treatment necessary to making decisions between groups
Time Frame: 3 months
Knowledge questionnaire: % correct answers
3 months
Compare difference in knowledge of disease and treatment necessary to making decisions between groups
Time Frame: 6 months
Knowledge questionnaire: % correct answers
6 months
Compare difference in knowledge of disease and treatment necessary to making decisions between groups
Time Frame: 9 months
Knowledge questionnaire: % correct answers
9 months
Compare difference in knowledge of disease and treatment necessary to making decisions between groups
Time Frame: 12 months
Knowledge questionnaire: % correct answers
12 months
Compare difference in patient attitude towards the treatment between groups
Time Frame: 3 months
Beliefs about Medicines Questionnaire: 18 questions 1-5
3 months
Compare difference in patient attitude towards the treatment between groups
Time Frame: 6 months
Beliefs about Medicines Questionnaire: 18 questions 1-5
6 months
Compare difference in patient attitude towards the treatment between groups
Time Frame: 9 months
Beliefs about Medicines Questionnaire: 18 questions 1-5
9 months
Compare difference in patient attitude towards the treatment between groups
Time Frame: 12 months
Beliefs about Medicines Questionnaire: 18 questions 1-5
12 months
Compare number and duration of mood episodes between groups months
Time Frame: 3 months
number of events; number of days
3 months
Compare number and duration of mood episodes between groups months
Time Frame: 6 months
number of events; number of days
6 months
Compare number and duration of mood episodes between groups months
Time Frame: 9 months
number of events; number of days
9 months
Compare number and duration of mood episodes between groups months
Time Frame: 12 months
number of events; number of days
12 months
Compare number and duration of hospitalizations in psychiatric service between groups
Time Frame: 3 months
number of events; number of days
3 months
Compare number and duration of hospitalizations in psychiatric service between groups
Time Frame: 6 months
number of events; number of days
6 months
Compare number and duration of hospitalizations in psychiatric service between groups
Time Frame: 9 months
number of events; number of days
9 months
Compare number and duration of hospitalizations in psychiatric service between groups
Time Frame: 12 months
number of events; number of days
12 months
Compare manic symptomatology during evaluations between groups
Time Frame: 3 months
Young Mania Rating Scale
3 months
Compare manic symptomatology during evaluations between groups
Time Frame: 6 months
Young Mania Rating Scale
6 months
Compare manic symptomatology during evaluations between groups
Time Frame: 9 months
Young Mania Rating Scale
9 months
Compare manic symptomatology during evaluations between groups
Time Frame: 12 months
Young Mania Rating Scale
12 months
Compare the depressive symptomatology during evaluations between groups
Time Frame: 3 months
Montgomery-Asberg Depression Rating Scale
3 months
Compare the depressive symptomatology during evaluations between groups
Time Frame: 6 months
Montgomery-Asberg Depression Rating Scale
6 months
Compare the depressive symptomatology during evaluations between groups
Time Frame: 9 months
Montgomery-Asberg Depression Rating Scale
9 months
Compare the depressive symptomatology during evaluations between groups
Time Frame: 12 months
Montgomery-Asberg Depression Rating Scale
12 months
Compare severity and intensity of suicidal ideas between groups
Time Frame: 3 months
Columbia-Suicide Severity Rating Scale
3 months
Compare severity and intensity of suicidal ideas between groups
Time Frame: 6 months
Columbia-Suicide Severity Rating Scale
6 months
Compare severity and intensity of suicidal ideas between groups
Time Frame: 9 months
Columbia-Suicide Severity Rating Scale
9 months
Compare severity and intensity of suicidal ideas between groups
Time Frame: 12 months
Columbia-Suicide Severity Rating Scale
12 months
Compare the psychosocial functioning between groups
Time Frame: 3 months
Functioning Assessment Short Test (0-72)
3 months
Compare the psychosocial functioning between groups
Time Frame: 6 months
Functioning Assessment Short Test (0-72)
6 months
Compare the psychosocial functioning between groups
Time Frame: 9 months
Functioning Assessment Short Test (0-72)
9 months
Compare the psychosocial functioning between groups
Time Frame: 12 months
Functioning Assessment Short Test (0-72)
12 months
Compare quality of life between groups
Time Frame: 3 months
WHOQOL-BREF (0-100)
3 months
Compare quality of life between groups
Time Frame: 6 months
WHOQOL-BREF (0-100)
6 months
Compare quality of life between groups
Time Frame: 9 months
WHOQOL-BREF (0-100)
9 months
Compare quality of life between groups
Time Frame: 12 months
WHOQOL-BREF (0-100)
12 months
Compare length of consultations between groups
Time Frame: every consultation for 12 months
minutes
every consultation for 12 months
Clinician satisfaction concerning the therapeutic decisions taken between groups
Time Frame: 3 months
adapted QSH-45 doctor version 3 questions scored 1-5
3 months
Clinician satisfaction concerning the therapeutic decisions taken between groups
Time Frame: 6 months
adapted QSH-45 doctor version 3 questions scored 1-5
6 months
Clinician satisfaction concerning the therapeutic decisions taken between groups
Time Frame: 9 months
adapted QSH-45 doctor version 3 questions scored 1-5
9 months
Clinician satisfaction concerning the therapeutic decisions taken between groups
Time Frame: 12 months
adapted QSH-45 doctor version 3 questions scored 1-5
12 months
Clinician satisfaction concerning the decision-making process between groups
Time Frame: 3 months
Adapted clinical decision making involvement and satisfaction score doctor version 3: questions scored 1-5
3 months
Clinician satisfaction concerning the decision-making process between groups
Time Frame: 6 months
Adapted clinical decision making involvement and satisfaction score doctor version 3: questions scored 1-5
6 months
Clinician satisfaction concerning the decision-making process between groups
Time Frame: 9 months
Adapted clinical decision making involvement and satisfaction score doctor version 3: questions scored 1-5
9 months
Clinician satisfaction concerning the decision-making process between groups
Time Frame: 12 months
Adapted clinical decision making involvement and satisfaction score doctor version 3: questions scored 1-5
12 months
Clinician perceptions related to the uncertainty of the medical decisions taken between groups
Time Frame: 3 months
decisional conflict scale doctor version (0-100)
3 months
Clinician perceptions related to the uncertainty of the medical decisions taken between groups
Time Frame: 6 months
decisional conflict scale doctor version (0-100)
6 months
Clinician perceptions related to the uncertainty of the medical decisions taken between groups
Time Frame: 9 months
decisional conflict scale doctor version (0-100)
9 months
Clinician perceptions related to the uncertainty of the medical decisions taken between groups
Time Frame: 12 months
decisional conflict scale doctor version (0-100)
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Nīmes

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ludovic SAMALIN, University Hospital, Clermont-Ferrand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 24, 2018

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 7, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 7, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 10, 2017

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 18, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PREPS/2016/LS-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Bipolar Disorder

Clinical Trials on Shared-decision making process

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings