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

  • STATUS
    Recruiting
  • End date
    May 25, 2022
  • participants needed
    180
  • sponsor
    Centre Hospitalier Universitaire de Nīmes
Updated on 25 July 2021
analgesic
depression
depressed mood

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.

Description

Participants will be randomized to two doses of buprenorphine (0.4mg and 0.8mg) or placebo. The duration of treatment will be 21 days with 7 days withdrawal period. Two follow-up phone calls at 3 and 6 months will investigate occurence of suicidal behavior.

The main outcome will be changes in suicidal ideas levels during the first week.

Secondary outcomes will be changes in suicidal ideas during the following 21 days, changes in depression and psychological pain levels over the first 28 days, dropout rates, reasons and occurence of side effects over the first 28 days, withdrawal symptoms dung the withdrawal period, changes in neuropsychological and neuroimaging measures between Day 0 and Day 28.

Blood and stool samples will be collected at 4 time points and stored in a biobank for future analyses.

Details
Condition Suicidal Ideation, Suicide, Major Depressive Episode, major depressive disorder, single episode
Treatment Placebo, Buprenorphine
Clinical Study IdentifierNCT03646058
SponsorCentre Hospitalier Universitaire de Nīmes
Last Modified on25 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

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 has a lifetime history of substance use disorder (except tobacco and caffeine), moderate to severe, according to criteria of the "Diagnostic and Statistical Manual of Mental Disorders
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
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