NCT04740463

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 2, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 5, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2022

Completed
Last Updated

May 21, 2021

Status Verified

February 1, 2021

Enrollment Period

8 months

First QC Date

February 2, 2021

Last Update Submit

May 18, 2021

Conditions

Keywords

Capacity to consentEuthanasia

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

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

RECRUITING

MeSH Terms

Conditions

Suicide, Assisted

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • Emilie Olie, MD PhD

    University Hospital, Montpellier

    STUDY DIRECTOR

Central Study Contacts

Thomas CATANZARO, MD (intern)

CONTACT

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

Locations