This study aims at investigating if adjunctive buprenorphine at low dose to treatment as usual is effective in reducing severe suicidal ideas in major depressive episode, and at determining the most effective dose.
The patient has been correctly informed.
The patient must have given his/her informed and signed the consent form.
The patient must be insured or beneficiary of a health insurance plan.
The patient is at least 18 years old and 65 years old at the most.
The patient is participating in another interventional trial;
The patient is in an exclusion period determined by a previous study;
The patient is under judicial protection, or is an adult under guardianship;
The patient is under compulsory admission;
Parallel
Buprenorphine
DrugBuprenorphine, 0.4mg pills, sublingual
Placebo
DrugPlacebo pills, sublingual, specifically made to mimick buprenorphine pills
Changes in Beck Scale for Suicidal Ideation (SSI) scores from Day 0 to 7
Clinician-based questionnaire measuring level of suicidal ideas over the last 7 days; 21 items scored 0 to 2; total score ranges from 0 to 38 (last 2 items not counted), higher scores mean more intense suicidal ideas.
Changes in Beck Scale for Suicidal Ideation (SSI) scores
Clinician-based questionnaire measuring level of suicidal ideas over the last 7 days; 21 items scored 0 to 2; total score ranges from 0 to 38 (last 2 items not counted); higher scores mean more intense suicidal ideas.
Changes in Beck Depression Inventory II (BDI-II) scores from Day 0 to 28
Self questionnaire measuring depression level over the last 7 days; 13 items scored 0 to 3, with the total score ranging from 0 to 39; higher scores mean higher level of depression.
Changes in Montgomery-Asberg Depression Rating Scale (MADRS) from Day 0 to 28
Clinician-based questionnaire measuring the level of depression of the last 7 days; 10 items score 0 to 6, with the total scores ranging fron 0 to 60; Higher scores mean higher level of depression.
Changes in Physical and Psychological Pain - Visual Analog Scale (PPP-VAS) scores from Day 0 to 28
Visual Analog Scale measuring physical then psychological pain over 3 periods each (current, worst over the last 7 days, mean over the last 7 days); 6 dimensions in total; each dimension is scored from 0 (no pain) to 10 (maximal pain).
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