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

Plain Language Summary

Simplified for easier understanding

This trial is studying whether adding low doses of buprenorphine — a medication typically used for pain and opioid treatment — can quickly reduce severe suicidal thoughts in people hospitalized during a major depressive episode. **You may be eligible if...** - You are between 18 and 65 years old - You are currently hospitalized because of a major depressive episode - You are experiencing severe suicidal thoughts (with or without a recent attempt) - You are covered by health insurance - You have given your written informed consent **You may NOT be eligible if...** - You are currently dependent on opioids or other drugs of abuse - You have a serious heart condition (such as a prolonged QT interval on ECG) - You have severe liver or kidney disease - You are already taking certain medications that interact with buprenorphine (such as MAO inhibitors) - You are pregnant or breastfeeding - You have a diagnosis of a psychotic disorder (like schizophrenia) - You are under legal guardianship or otherwise unable to consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

View Full Details on ClinicalTrials.gov

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NCT03646058


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