Actively Recruiting
Add-on Buprenorphine at Analgesic Doses for the Treatment of Severe Suicidal Ideas During a Major Depressive Episode
Led by Centre Hospitalier Universitaire de Nīmes · Updated on 2025-08-21
180
Participants Needed
9
Research Sites
272 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Add-on Buprenorphine at Analgesic Doses for the Treatment of Severe Suicidal Ideas During a Major Depressive Episode
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient has been correctly informed about the study.
- Patient has given informed consent and signed the consent form.
- Patient is insured or has health insurance coverage.
- Patient is between 18 and 65 years old.
- Patient is hospitalized or receiving outpatient consultation.
- Patient currently has a major depressive episode without psychotic features as defined by DSM criteria.
- Patient has a Montgomery-Asberg Depression Rating Scale score greater than 20.
- Patient has a Scale for Suicidal Ideation (SSI) score greater than 8.
You will not qualify if you...
- Patient is participating in another interventional trial.
- Patient is within an exclusion period from a previous study.
- Patient is under judicial protection or adult guardianship.
- Patient is under compulsory admission.
- Patient refuses to sign consent.
- Patient cannot be properly informed about the study.
- Patient is pregnant or breastfeeding.
- Patient has schizophrenia.
- Patient had moderate to severe alcohol or substance use disorder (except tobacco and caffeine) in the last 12 months according to DSM-5.
- Patient currently has a severe or unstable medical condition including severe respiratory or liver failure or painful condition.
- Patient has known current sleep apnea.
- Patient currently takes analgesic treatments including NSAIDs or paracetamol.
- Patient currently takes central nervous system depressants at sedative doses including benzodiazepines, antihistamines, or sedative antipsychotics.
- Patient currently takes major CYP3A4 inhibitors or inducers.
- Patient received electroconvulsivotherapy in the last 3 months.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
Ch Perrens
Bordeaux, France, France, 33076
Not Yet Recruiting
2
CHU Bicêtre
Le Kremlin-Bicêtre, France, 94270
Actively Recruiting
3
Hospices Civils de Lyon
Lyon, France, 69003
Actively Recruiting
4
CAPPA Jacques PREVERT
Nantes, France, 44000
Actively Recruiting
5
CHU Nîmes
Nîmes, France, 30029
Actively Recruiting
6
CH Sainte-Anne
Paris, France, 75674
Actively Recruiting
7
CH Henri Laborit
Poitiers, France, 86021
Actively Recruiting
8
Chu Toulouse Hopital Purpan
Toulouse, France, 31059
Not Yet Recruiting
9
CHU de Tours
Tours, France, 37540
Actively Recruiting
Research Team
F
Fabrice Jollant, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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