Actively Recruiting

Phase 3
Age: 18Years - 65Years
All Genders
NCT03646058

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

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

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.
Not Eligible

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

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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

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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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Add-on Buprenorphine at Analgesic Doses for the Treatment of Severe Suicidal Ideas During a Major Depressive Episode | DecenTrialz