Using buprenorphine to reduce severe suicidal thoughts in depressed patients

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

This study is testing if low doses of buprenorphine can help reduce severe suicidal thoughts in people experiencing major depression.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Centre Hospitalier Universitaire de Nīmes (Academic / other)
• Locations: 9 sites (Bordeaux, France and 8 other locations)
• Trial ID: NCT03646058 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of adjunctive buprenorphine at low doses in reducing severe suicidal ideation during a major depressive episode. Participants will be randomly assigned to receive either buprenorphine at doses of 0.4mg or 0.8mg, or a placebo, over a treatment period of 21 days, followed by a 7-day withdrawal period. The primary outcome will assess changes in suicidal ideation levels during the first week, while secondary outcomes will evaluate depression levels, dropout rates, side effects, and neuropsychological measures. Blood and stool samples will also be collected for future analyses.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with a current major depressive episode and severe suicidal ideation.

Not a fit: Patients with psychotic features, those under judicial protection, or individuals currently participating in another interventional trial may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce suicidal thoughts in patients experiencing major depressive episodes.

How similar studies have performed: While the use of buprenorphine for depression is being explored, this specific approach targeting severe suicidal ideation is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

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 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.

Where this trial is running

Bordeaux, France and 8 other locations

• Ch Perrens — Bordeaux, France, France (Not_yet_recruiting)
• CHU Bicêtre — Le Kremlin-Bicêtre, France (Recruiting)
• Hospices Civils de Lyon — Lyon, France (Recruiting)
• CAPPA Jacques PREVERT — Nantes, France (Recruiting)
• CHU Nîmes — Nîmes, France (Recruiting)
• CH Sainte-Anne — Paris, France (Recruiting)
• CH Henri Laborit — Poitiers, France (Recruiting)
• Chu Toulouse Hopital Purpan — Toulouse, France (Not_yet_recruiting)
• CHU de Tours — Tours, France (Recruiting)

Study contacts

• Principal investigator: Fabrice Jollant, MD — Hôpital Sainte-Anne
• Study coordinator: Fabrice Jollant, MD

Conditions Suicidal Ideation; Major Depressive Episode; Treatment; Suicidal ideas; Depression; Buprenorphine; Opioid agonist; Mental pain