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Assessement of Capacity to Consent

Assessement of Capacity to Consent in Depressed Patients

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04740463
Enrollment
70
Registered
2021-02-05
Start date
2021-01-01
Completion date
2022-01-30
Last updated
2021-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Episode

Keywords

Capacity to consent, Euthanasia

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.

Interventions

None listed

Sponsors

University Hospital, Montpellier
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Capacity to consent (MacCAT-T)1 dayaassessment 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.

Secondary

MeasureTime frameDescription
Insight (BCIS)1 dayinsight 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)

Other

MeasureTime frameDescription
Depression (BDI)1 daydepression assesement based on the Beck Depression Inventory (BDI) score. Total score ranges from 0 to 63. Higher scores indicate more severe depression symptoms.
Depression (MADRS)1 daydepression 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.
Suicidality (MADRS)1 daysuicidality 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).

Countries

France

Contacts

Primary ContactEmilie Olie, MD PhD
e-olie@chu-montpellier.fr+33 4 67 33 85 81
Backup ContactThomas CATANZARO, MD (intern)
t-catanzaro@chu-montpellier.fr4 67 33 82 89

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026