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

NCT03646058 | Recruiting Phase 3

• 1 other identifier: PHRC-N/2017/FJ-01
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Suicidal Ideation; Major Depressive Episode

Keywords

Treatment; Suicidal ideas; Depression; Buprenorphine; Opioid agonist; Mental pain

Outcome Measures

Primary Outcomes (1)

• Changes in Beck Scale for Suicidal Ideation (SSI) scores from Day 0 to 7

  Clinician-based questionnaire measuring level of suicidal ideas over the last 7 days; 21 items scored 0 to 2; total score ranges from 0 to 38 (last 2 items not counted), higher scores mean more intense suicidal ideas.

  7 days

Secondary Outcomes (19)

• Changes in Beck Scale for Suicidal Ideation (SSI) scores

  Day 8 to day 28

• Changes in Beck Depression Inventory II (BDI-II) scores from Day 0 to 28

  28 days

• Changes in Montgomery-Asberg Depression Rating Scale (MADRS) from Day 0 to 28

  28 days

• Changes in Physical and Psychological Pain - Visual Analog Scale (PPP-VAS) scores from Day 0 to 28

  28 days

• Reasons for discontinuing treatment over the first 28 days

  28 days

Study Arms (3)

Placebo

PLACEBO COMPARATOR

2 placebo pills sublingual during 28 days

Drug: Placebo

0.4mg buprenorphine

EXPERIMENTAL

1 pill of 0.4 mg buprenorphine + 1 placebo pill per day for 21 days, then 2 placebo pills per day for 1 week, all sublingual.

Drug: Buprenorphine

0.8mg buprenorphine

EXPERIMENTAL

1 pill of 0.4 mg buprenorphine + 1 placebo pill per day for 3 days, then 2 pills of 0.4mg buprenorphine per day for 18 days, then 1 pill of 0.4 mg + 1 placebo pill per day for 3 days, then 2 placebo pills per day for 4 days, all sublingual.

Drug: Buprenorphine

Interventions

Buprenorphine DRUG

Buprenorphine, 0.4mg pills, sublingual

Also known as: Temgesic

0.4mg buprenorphine; 0.8mg buprenorphine

Placebo DRUG

Placebo pills, sublingual, specifically made to mimick buprenorphine pills

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• The patient is participating in another interventional trial;
• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (9)

Ch Perrens

Bordeaux, France, 33076, France

NOT YET RECRUITING

CHU Bicêtre

Le Kremlin-Bicêtre, 94270, France

RECRUITING

Hospices Civils de Lyon

Lyon, 69003, France

RECRUITING

CAPPA Jacques PREVERT

Nantes, 44000, France

RECRUITING

CHU Nîmes

Nîmes, 30029, France

RECRUITING

CH Sainte-Anne

Paris, 75674, France

RECRUITING

CH Henri Laborit

Poitiers, 86021, France

RECRUITING

Chu Toulouse Hopital Purpan

Toulouse, 31059, France

NOT YET RECRUITING

CHU de Tours

Tours, 37540, France

RECRUITING

MeSH Terms

Conditions

Suicidal Ideation; Depression

Interventions

Buprenorphine

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Fabrice Jollant, MD

  Hôpital Sainte-Anne

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fabrice Jollant, MD

CONTACT

+33(0)1 45 65 85 72; fabrice.jollant@parisdescartes.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2018
• First Posted: August 24, 2018
• Study Start: October 10, 2021
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: August 21, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (9)