Assessement of Capacity to Consent

Major Depressive Episode Clinical Trial

Official title:

Assessement of Capacity to Consent in Depressed Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04740463
• Other study ID #: RECHMPL21_0033
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Major Depressive Episode

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