Assessement of Capacity to Consent
1 other identifier
observational
70
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2021
CompletedFirst Submitted
Initial submission to the registry
February 2, 2021
CompletedFirst Posted
Study publicly available on registry
February 5, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2022
CompletedMay 21, 2021
February 1, 2021
8 months
February 2, 2021
May 18, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Insight (BCIS)
1 day
Other Outcomes (3)
Depression (BDI)
1 day
Depression (MADRS)
1 day
Suicidality (MADRS)
1 day
Eligibility Criteria
Depressed patients (consultation or hospitalization)
You may qualify if:
- 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
You may not qualify if:
- \- Refusal to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University hospital
Montpellier, 34295, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Emilie Olie, MD PhD
University Hospital, Montpellier
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 2, 2021
First Posted
February 5, 2021
Study Start
January 1, 2021
Primary Completion
September 1, 2021
Study Completion
January 30, 2022
Last Updated
May 21, 2021
Record last verified: 2021-02