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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04740463
Other study ID # RECHMPL21_0033
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2021
Est. completion date January 30, 2022

Study information

Verified date February 2021
Source University Hospital, Montpellier
Contact Emilie Olie, MD PhD
Phone +33 4 67 33 85 81
Email e-olie@chu-montpellier.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Any patient can request euthanasia in many of our neighbouring European countries as long as informed consent is given. Psychiatric evaluation is not always mandatory. Faced with the increasing emergence of euthanasia requests in different countries from patients under psychiatric care in France for severe depressive episodes, question arises of a possible alteration in the capacity to give consent in the context of a severe depressive episode. This is a Social and Human Sciences study which does not aim to modify the usual management of patients.


Recruitment information / eligibility

Status Recruiting
Enrollment 70
Est. completion date January 30, 2022
Est. primary completion date September 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion criteria: - Age between 18 and 75 - Ability to understand and participate in the interview - French-speaking - Presence of a current characterized depressive episode according to DSM-5 diagnostic criteria Exclusion criteria: - Refusal to participate

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France University hospital Montpellier

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Other Depression (BDI) depression assesement based on the Beck Depression Inventory (BDI) score. Total score ranges from 0 to 63. Higher scores indicate more severe depression symptoms. 1 day
Other Depression (MADRS) depression assessement based on the Montgomery Asberg Depression Rating Scale (MADRS) score. Total score ranges from 0 to 60. Higher scores indicate more severe depression symptoms. 1 day
Other Suicidality (MADRS) suicidality assessement based on the 10th MADRS item. The item ranges from 0 (enjoys life or takes it as it come) to 6 (explicit plans for suicide when there is an opportunity. Active preparations for suicide). 1 day
Primary Capacity to consent (MacCAT-T) aassessment of the capacity to consent based on the MacArthur Competence Assessment Tool-Treatment (MacCAT-T). The questionnaire assesses four competences in consent : understanding (score ranges from 0 to 6), appreciation (score ranges from 0 to 4), reasoning (score ranges from 0 to 8) and expressing a choice (score ranges from 0 to 2).
A low score on each of these dimensions calls into question the patient's ability to consent.
1 day
Secondary Insight (BCIS) insight assessement based on the Beck Cognitive Insight Scale (BCIS). The questionnaire contains two sub-scales : self- reflection (9 items) and self-certainty (6 items). Each items ranges from 0 (do not agree at all) to 3 (agree completely) 1 day
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