RecruitingPhase 3NCT03646058

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


Sponsor

Centre Hospitalier Universitaire de Nīmes

Enrollment

180 participants

Start Date

Oct 10, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria8

  • 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 hospitalized or followed in consultation.
  • The patient has a current major depressive episode without psychotic features according to the criteria of the "Diagnostic and Statistical Manual of Mental Disorders"
  • The patient has a score \> 20 of the "Montgomery-Asberg Depression Rating Scale".
  • The patient has a current Scale for Suicidal Ideation (SSI) score \> 8.

Exclusion Criteria15

  • 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;
  • The patient refuses to sign the consent;
  • it is impossible to correctly inform the patient.
  • The patient is pregnant or breastfeeding.
  • The patient suffers from schizophrenia;
  • The patient suffered from moderate to severe alcohol use disorder or substance use disorder (except tobacco and caffeine) over the last 12 months according to DSM-5 criteria ;
  • The patient currently suffers from severe and/or unstable medical condition (including severe respiratory or hepatic insufficiency) or a painful medical condition;
  • The patient has a current known sleep apnea.
  • The patient currently takes analgesic treatment (including Nonsteroidal anti-inflammatory drug and paracetamol);
  • The patient currently takes central nervous depressant drugs at sedative doses (based on the investigator's assessment), including benzodiazepines, antihistamines, and sedative antipsychotics;
  • The patient currently takes major CYP3A4 Inhibitors and inducers;
  • The patient currently takes has received Electroconvulsivotherapy over the last 3 months.

Interventions

DRUGBuprenorphine

Buprenorphine, 0.4mg pills, sublingual

DRUGPlacebo

Placebo pills, sublingual, specifically made to mimick buprenorphine pills


Locations(9)

Ch Perrens

Bordeaux, France, France

CHU Bicêtre

Le Kremlin-Bicêtre, France

Hospices Civils de Lyon

Lyon, France

CAPPA Jacques PREVERT

Nantes, France

CHU Nîmes

Nîmes, France

CH Sainte-Anne

Paris, France

CH Henri Laborit

Poitiers, France

Chu Toulouse Hopital Purpan

Toulouse, France

CHU de Tours

Tours, France

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NCT03646058


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