Major Depressive Episode Clinical Trial
Official title:
Assessement of Capacity to Consent in Depressed Patients
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.
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 |
Country | Name | City | State |
---|---|---|---|
France | University hospital | Montpellier |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Montpellier |
France,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03256162 -
Ketamine as an Adjunctive Therapy for Major Depression
|
Phase 1 | |
Completed |
NCT01944293 -
Ketamine for Suicidality in Bipolar Depression
|
Phase 1/Phase 2 | |
Recruiting |
NCT01441505 -
A Study of Ketamine as an Antidepressant
|
Phase 2 | |
Active, not recruiting |
NCT03487926 -
Microglial Activation in Inflammatory Bowel Disease
|
||
Recruiting |
NCT04939649 -
Ketamine as an Adjunctive Therapy for Major Depression (2)
|
Phase 3 | |
Recruiting |
NCT05028738 -
Patient-oriented Randomized Pragmatic Feasibility Trial With rTMS in Depression and Anxiety
|
N/A | |
Recruiting |
NCT03646058 -
Add-on Buprenorphine at Analgesic Doses for the Treatment of Severe Suicidal Ideas During a Major Depressive Episode
|
Phase 3 | |
Not yet recruiting |
NCT06117397 -
A Text Messaging Intervention to Reduce Perinatal Depression Risk
|
N/A | |
Completed |
NCT03735576 -
Cognitive Behavioural Therapy for the Treatment of Late Life Depression
|
N/A | |
Recruiting |
NCT04999553 -
Left vs. Right Non-Inferiority Trial
|
N/A | |
Completed |
NCT03716869 -
Universal vs. Targeted School Screening for Adolescent Major Depressive Disorder
|
N/A | |
Recruiting |
NCT02824081 -
Neuroinflammation, Serotonin, Impulsivity and Suicide
|
N/A | |
Terminated |
NCT01099592 -
Antidepressants to Promote Recovery of Cardiac Patients Suffering From Depression
|
Phase 4 | |
Completed |
NCT03752853 -
Stress Systems and Psychotherapy in Depression
|
N/A | |
Recruiting |
NCT04480918 -
University of Iowa Interventional Psychiatry Service Patient Registry
|
||
Recruiting |
NCT04130958 -
Circuit-Based Approach to Suicide: Biomarkers, Predictors, and Novel Therapeutics
|
N/A | |
Completed |
NCT03190772 -
The Role of Expectations in the Pharmacological Treatment of Depression - An Experimental Investigation
|
N/A | |
Recruiting |
NCT04832750 -
Depression-Reduction by Accelerated Personalized NeuroModulation and Its Effects on Sleep
|
||
Terminated |
NCT02839798 -
NeoSync TMS Treatment for Bipolar I Depression
|
Phase 2 | |
Completed |
NCT00852592 -
Light Therapy for Bipolar Disorder. Efficacy of Light Therapy for Bipolar Depression: A Randomized Controlled Trial
|
Phase 3 |