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Bipolar DisorderShareD-BDNCT03245593

Shared Medical Decision Making in the Prophylactic Treatment of Bipolar Disorder

A study testing Shared-decision making process in people with Bipolar Disorder, run by Centre Hospitalier Universitaire de Nīmes at 16 sites in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bipolar Disorder
What is being tested?
Shared-decision making process
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
16 sitesFrance
Study dates
24 Apr 2018to Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

France16 sites

  • Ch Beziers

    Béziers, 34500

  • CH Charles Perrens

    Bordeaux, 33076

  • CH le Vinatier

    Bron, 69678

  • CHU de Clermont Ferrand - Hôpital Gabriel-Montpied

    Clermont-Ferrand, 63003

  • Chu Gabriel Montpied Clermont Ferrand

    Clermont-Ferrand, 63003

  • CH Sainte-Marie de Clermont-Ferrand

    Clermont-Ferrand, 63037

  • APHP - Centre Hospitalier Henri Mondor

    Créteil, 94010

  • CHU de Grenoble - Hôpital Albert Michallon

    Grenoble, 38043

  • CH Limoges

    Limoges, 87025

  • APHM - Hôpital Sainte-Marguerite

    Marseille, 13274

  • CHU de Montpellier - Hôpital Lapeyronie

    Montpellier, 34295

  • CHU Nancy

    Nancy, 54000

  • CHU Nantes

    Nantes, 44000

  • Clinique des troubles thymiques

    Nîmes, 30000

  • CHU Nimes

    Nîmes, 30029

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

    Paris, 75475

Other trials in France

About this study

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

Being tested
Shared-decision making process, standard care
Medical subject headings
Bipolar Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Shared-decision making processOther

    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 careOther

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

Study groups in NCT03245593
Study groupRoleWhat they receive
Shared Decision making for careExperimentalNot described
Receives: Other: Shared-decision making process
Standard decision making for careOtherNot described
Receives: Other: standard care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Clinician Rating Scale (1-7)

    Measured: 12 months

Secondary outcomes (80)

  1. Study the clinician-reported difference between the 2 groups in medication adherence

    Clinician Rating Scale (1-7)

    Measured: 3 months

  2. Study the clinician-reported difference between the 2 groups in medication adherence

    Clinician Rating Scale (1-7)

    Measured: 6 months

  3. Study the clinician-reported difference between the 2 groups in medication adherence

    Clinician Rating Scale (1-7)

    Measured: 9 months

  4. Study the self-reported difference between the 2 groups in medication adherence

    Medication Adherence Rating Scale( 0-10),

    Measured: 3 months

  5. Study the self-reported difference between the 2 groups in medication adherence

    Medication Adherence Rating Scale( 0-10),

    Measured: 6 months

  6. Study the self-reported difference between the 2 groups in medication adherence

    Medication Adherence Rating Scale( 0-10),

    Measured: 9 months

  7. Study the self-reported difference between the 2 groups in medication adherence

    Medication Adherence Rating Scale( 0-10),

    Measured: 12 months

  8. Clinical evaluation of the difference between the 2 groups in medication adherence

    Plasma levels of medication for treatment of bipolar disorder, Lithium, anticonvulsants, second generation antipsychotics and antidepressants

    Measured: 3 months

  9. Clinical evaluation of the difference between the 2 groups in medication adherence

    Plasma levels of medication for treatment of bipolar disorder, Lithium, anticonvulsants, second generation antipsychotics and antidepressants

    Measured: 6 months

  10. Clinical evaluation of the difference between the 2 groups in medication adherence

    Plasma levels of medication for treatment of bipolar disorder, Lithium, anticonvulsants, second generation antipsychotics and antidepressants

    Measured: 9 months

  11. Clinical evaluation of the difference between the 2 groups in medication adherence

    Plasma levels of medication for treatment of bipolar disorder, Lithium, anticonvulsants, second generation antipsychotics and antidepressants

    Measured: 12 months

  12. Compare difference in the adherence to personalized follow-up between groups

    percentage of consultations missed

    Measured: 3 months

  13. Compare difference in the adherence to personalized follow-up between groups

    percentage of consultations missed

    Measured: 6 months

  14. Compare difference in the adherence to personalized follow-up between groups

    percentage of consultations missed

    Measured: 9 months

  15. Compare difference in the adherence to personalized follow-up between groups

    percentage of consultations missed

    Measured: 12 months

  16. Compare difference in patient perceptions related to the uncertainty of the medical decisions taken between groups

    decisional conflict scale (0-100)

    Measured: 3 months

  17. Compare difference in patient perceptions related to the uncertainty of the medical decisions taken between groups

    decisional conflict scale (0-100)

    Measured: 6 months

  18. Compare difference in patient perceptions related to the uncertainty of the medical decisions taken between groups

    decisional conflict scale (0-100)

    Measured: 9 months

  19. Compare difference in patient perceptions related to the uncertainty of the medical decisions taken between groups

    decisional conflict scale (0-100)

    Measured: 12 months

  20. Compare difference in patient satisfaction concerning the therapeutic decisions taken between groups

    adapted QSH-45: 3 questions scored 1-5

    Measured: 3 months

  21. Compare difference in patient satisfaction concerning the therapeutic decisions taken between groups

    adapted QSH-45: 3 questions scored 1-5

    Measured: 6 months

  22. Compare difference in patient satisfaction concerning the therapeutic decisions taken between groups

    adapted QSH-45: 3 questions scored 1-5

    Measured: 9 months

  23. Compare difference in patient satisfaction concerning the therapeutic decisions taken between groups

    adapted QSH-45: 3 questions scored 1-5

    Measured: 12 months

  24. Compare difference in patient satisfaction concerning the decision-making process between groups

    Adapted clinical decision making involvement and satisfaction score 3 questions scored 1-5

    Measured: 3 months

  25. Compare difference in patient satisfaction concerning the decision-making process between groups

    Adapted clinical decision making involvement and satisfaction score 3 questions scored 1-5

    Measured: 6 months

  26. Compare difference in patient satisfaction concerning the decision-making process between groups

    Adapted clinical decision making involvement and satisfaction score 3 questions scored 1-5

    Measured: 9 months

  27. Compare difference in patient satisfaction concerning the decision-making process between groups

    Adapted clinical decision making involvement and satisfaction score 3 questions scored 1-5

    Measured: 12 months

  28. Compare difference in therapeutic alliance between groups

    4-Point ordinal Alliance Scale

    Measured: 3 months

  29. Compare difference in therapeutic alliance between groups

    4-Point ordinal Alliance Scale

    Measured: 6 months

  30. Compare difference in therapeutic alliance between groups

    4-Point ordinal Alliance Scale

    Measured: 9 months

  31. Compare difference in therapeutic alliance between groups

    4-Point ordinal Alliance Scale

    Measured: 12 months

  32. Compare difference in knowledge of disease and treatment necessary to making decisions between groups

    Knowledge questionnaire: % correct answers

    Measured: 3 months

  33. Compare difference in knowledge of disease and treatment necessary to making decisions between groups

    Knowledge questionnaire: % correct answers

    Measured: 6 months

  34. Compare difference in knowledge of disease and treatment necessary to making decisions between groups

    Knowledge questionnaire: % correct answers

    Measured: 9 months

  35. Compare difference in knowledge of disease and treatment necessary to making decisions between groups

    Knowledge questionnaire: % correct answers

    Measured: 12 months

  36. Compare difference in patient attitude towards the treatment between groups

    Beliefs about Medicines Questionnaire: 18 questions 1-5

    Measured: 3 months

  37. Compare difference in patient attitude towards the treatment between groups

    Beliefs about Medicines Questionnaire: 18 questions 1-5

    Measured: 6 months

  38. Compare difference in patient attitude towards the treatment between groups

    Beliefs about Medicines Questionnaire: 18 questions 1-5

    Measured: 9 months

  39. Compare difference in patient attitude towards the treatment between groups

    Beliefs about Medicines Questionnaire: 18 questions 1-5

    Measured: 12 months

  40. Compare number and duration of mood episodes between groups months

    number of events; number of days

    Measured: 3 months

  41. Compare number and duration of mood episodes between groups months

    number of events; number of days

    Measured: 6 months

  42. Compare number and duration of mood episodes between groups months

    number of events; number of days

    Measured: 9 months

  43. Compare number and duration of mood episodes between groups months

    number of events; number of days

    Measured: 12 months

  44. Compare number and duration of hospitalizations in psychiatric service between groups

    number of events; number of days

    Measured: 3 months

  45. Compare number and duration of hospitalizations in psychiatric service between groups

    number of events; number of days

    Measured: 6 months

  46. Compare number and duration of hospitalizations in psychiatric service between groups

    number of events; number of days

    Measured: 9 months

  47. Compare number and duration of hospitalizations in psychiatric service between groups

    number of events; number of days

    Measured: 12 months

  48. Compare manic symptomatology during evaluations between groups

    Young Mania Rating Scale

    Measured: 3 months

  49. Compare manic symptomatology during evaluations between groups

    Young Mania Rating Scale

    Measured: 6 months

  50. Compare manic symptomatology during evaluations between groups

    Young Mania Rating Scale

    Measured: 9 months

  51. Compare manic symptomatology during evaluations between groups

    Young Mania Rating Scale

    Measured: 12 months

  52. Compare the depressive symptomatology during evaluations between groups

    Montgomery-Asberg Depression Rating Scale

    Measured: 3 months

  53. Compare the depressive symptomatology during evaluations between groups

    Montgomery-Asberg Depression Rating Scale

    Measured: 6 months

  54. Compare the depressive symptomatology during evaluations between groups

    Montgomery-Asberg Depression Rating Scale

    Measured: 9 months

  55. Compare the depressive symptomatology during evaluations between groups

    Montgomery-Asberg Depression Rating Scale

    Measured: 12 months

  56. Compare severity and intensity of suicidal ideas between groups

    Columbia-Suicide Severity Rating Scale

    Measured: 3 months

  57. Compare severity and intensity of suicidal ideas between groups

    Columbia-Suicide Severity Rating Scale

    Measured: 6 months

  58. Compare severity and intensity of suicidal ideas between groups

    Columbia-Suicide Severity Rating Scale

    Measured: 9 months

  59. Compare severity and intensity of suicidal ideas between groups

    Columbia-Suicide Severity Rating Scale

    Measured: 12 months

  60. Compare the psychosocial functioning between groups

    Functioning Assessment Short Test (0-72)

    Measured: 3 months

  61. Compare the psychosocial functioning between groups

    Functioning Assessment Short Test (0-72)

    Measured: 6 months

  62. Compare the psychosocial functioning between groups

    Functioning Assessment Short Test (0-72)

    Measured: 9 months

  63. Compare the psychosocial functioning between groups

    Functioning Assessment Short Test (0-72)

    Measured: 12 months

  64. Compare quality of life between groups

    WHOQOL-BREF (0-100)

    Measured: 3 months

  65. Compare quality of life between groups

    WHOQOL-BREF (0-100)

    Measured: 6 months

  66. Compare quality of life between groups

    WHOQOL-BREF (0-100)

    Measured: 9 months

  67. Compare quality of life between groups

    WHOQOL-BREF (0-100)

    Measured: 12 months

  68. Compare length of consultations between groups

    minutes

    Measured: every consultation for 12 months

  69. Clinician satisfaction concerning the therapeutic decisions taken between groups

    adapted QSH-45 doctor version 3 questions scored 1-5

    Measured: 3 months

  70. Clinician satisfaction concerning the therapeutic decisions taken between groups

    adapted QSH-45 doctor version 3 questions scored 1-5

    Measured: 6 months

  71. Clinician satisfaction concerning the therapeutic decisions taken between groups

    adapted QSH-45 doctor version 3 questions scored 1-5

    Measured: 9 months

  72. Clinician satisfaction concerning the therapeutic decisions taken between groups

    adapted QSH-45 doctor version 3 questions scored 1-5

    Measured: 12 months

  73. Clinician satisfaction concerning the decision-making process between groups

    Adapted clinical decision making involvement and satisfaction score doctor version 3: questions scored 1-5

    Measured: 3 months

  74. Clinician satisfaction concerning the decision-making process between groups

    Adapted clinical decision making involvement and satisfaction score doctor version 3: questions scored 1-5

    Measured: 6 months

  75. Clinician satisfaction concerning the decision-making process between groups

    Adapted clinical decision making involvement and satisfaction score doctor version 3: questions scored 1-5

    Measured: 9 months

  76. Clinician satisfaction concerning the decision-making process between groups

    Adapted clinical decision making involvement and satisfaction score doctor version 3: questions scored 1-5

    Measured: 12 months

  77. Clinician perceptions related to the uncertainty of the medical decisions taken between groups

    decisional conflict scale doctor version (0-100)

    Measured: 3 months

  78. Clinician perceptions related to the uncertainty of the medical decisions taken between groups

    decisional conflict scale doctor version (0-100)

    Measured: 6 months

  79. Clinician perceptions related to the uncertainty of the medical decisions taken between groups

    decisional conflict scale doctor version (0-100)

    Measured: 9 months

  80. Clinician perceptions related to the uncertainty of the medical decisions taken between groups

    decisional conflict scale doctor version (0-100)

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Aug 2017
  2. Study start24 Apr 2018
  3. Primary completionDec 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03245593
Sponsor's protocol ID
PREPS/2016/LS-01
Acronym
ShareD-BD
Status last verified
Feb 2025
First submitted
7 Aug 2017
Last updated
18 Dec 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 29653535

Questions about this trial

What is this clinical trial studying?

A study testing Shared-decision making process in people with Bipolar Disorder, run by Centre Hospitalier Universitaire de Nīmes at 16 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03245593, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.

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