Using buprenorphine to reduce severe suicidal thoughts in depressed patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Principal investigator: Fabrice Jollant, MD — Hôpital Sainte-Anne
• Study coordinator: Fabrice Jollant, MD
• Email: fabrice.jollant@parisdescartes.fr
• Phone: +33(0)1 45 65 85 72

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Sensation Seeking and TMS Response in TRD: Does Personality Shape Treatment Outcomes?

  This real-world study tests whether people with treatment-resistant depression who have higher sensation-seeking traits respond differently to TMS treatment.

  Recruiting Technical University of Munich · München, Bavaria · NCT07889739

• Multi-layered digital monitoring and pharmacogenomics to prevent suicide in adults with depression

  This study tests whether a digital monitoring system, a digital safety plan, and pharmacogenetic-guided care can reduce suicide re-attempts in adults with depression.

  Recruiting Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz · Madrid, Madrid · NCT07885722

• Remote monitoring for adults with depression using ThIA Suivi

  This study tests whether adding the ThIA Suivi remote monitoring tool to usual psychiatric care helps adults with depression feel more improved after 3 months compared with standard care alone.

  Recruiting at 3 sites Phase 1 ThIA Santé Mentale · Bron and 2 other locations · NCT07878754

• Rapid relief of suicidal thoughts with ketamine and a crisis plan in the emergency department

  This study tests whether a single intramuscular dose of ketamine plus a brief Crisis Response Plan helps reduce suicidal thoughts in ED patients who are likely to be admitted.

  Recruiting Phase 2 The University of Texas Health Science Center at San Antonio · Fort Hood, Texas and 1 other locations · NCT07868913

• Recovery-oriented suicide prevention for young people at clinical high risk for psychosis

  This program tests a peer-supported, clinician-led suicide prevention group for young people at clinical high risk for psychosis to see if it helps reduce suicidal thoughts and support recovery.

  Recruiting at 2 sites University of California, San Diego · Los Angeles, California and 1 other locations · NCT07756567

• EEG microstates and inflammatory markers in treatment-resistant depression patients undergoing ECT

  This study tests how electroconvulsive therapy affects brain activity patterns seen in EEG and inflammatory biomarkers in adults with treatment-resistant major depression.

  Recruiting Istanbul University - Cerrahpasa · Istanbul, Bakırköy · NCT07748091

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.