Actively Recruiting
Add-on Buprenorphine at Analgesic Doses for the Treatment of Severe Suicidal Ideas During a Major Depressive Episode
Led by Centre Hospitalier Universitaire de Nīmes · Updated on 2025-08-21
180
Participants Needed
9
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying whether adding low doses of buprenorphine to usual treatment can help reduce severe suicidal thoughts in people experiencing a major depressive episode. The study is a phase 3 randomized clinical trial comparing two doses of buprenorphine (0.4 mg and 0.8 mg) with placebo to determine the most effective dose. It focuses on patients with high depression and suicidal ideation scores who are hospitalized or in consultation. Participants will be randomly assigned to receive either placebo pills or buprenorphine pills sublingually for 21 days, followed by a 7-day withdrawal period. The treatment groups include daily doses of 0.4 mg or 0.8 mg buprenorphine with specific dosing schedules over 28 days. Two follow-up phone calls will occur at 3 and 6 months to check for any suicidal behavior. During the study, researchers will assess changes in suicidal thoughts using the Beck Scale for Suicidal Ideation during the first week and over 28 days. They will also measure depression levels, psychological pain, side effects, withdrawal symptoms, and neuropsychological and brain imaging changes. Blood and stool samples will be collected at four time points and stored for future research. The total study duration includes treatment, withdrawal, and follow-up assessments over six months.
CONDITIONS
Brief Title
Add-on Buprenorphine at Analgesic Doses for the Treatment of Severe Suicidal Ideas During a Major Depressive Episode
Who Can Participate
Eligibility Criteria
You may qualify if you...
- The patient has been correctly informed.
- The patient must have given informed and signed consent.
- The patient must be insured or have health insurance.
- The patient is between 18 and 65 years old.
- The patient is hospitalized or followed in consultation.
- The patient has a current major depressive episode without psychotic features according to DSM criteria.
- The patient has a Montgomery-Asberg Depression Rating Scale score greater than 20.
- The patient has a Scale for Suicidal Ideation (SSI) score greater than 8.
You will not qualify if you...
- The patient is participating in another interventional trial.
- The patient is in an exclusion period from a previous study.
- The patient is under judicial protection or adult guardianship.
- The patient is under compulsory admission.
- The patient refuses to sign consent.
- It is impossible to correctly inform the patient.
- The patient is pregnant or breastfeeding.
- The patient suffers from schizophrenia.
- The patient had moderate to severe alcohol or substance use disorder (except tobacco and caffeine) in the last 12 months.
- The patient currently has severe or unstable medical conditions, including severe respiratory or liver failure, or painful conditions.
- The patient has known sleep apnea.
- The patient is taking analgesic treatment including NSAIDs or paracetamol.
- The patient is taking central nervous system depressants at sedative doses, including benzodiazepines, antihistamines, or sedative antipsychotics.
- The patient is taking major CYP3A4 inhibitors or inducers.
- The patient received electroconvulsivotherapy in the last 3 months.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - 28 days
Participants receive daily doses of buprenorphine or placebo for up to 21 days, followed by a 7-day withdrawal period.
Daily visits or assessments during treatment and withdrawal period
Duration - Up to 6 months after treatment
Participants receive follow-up phone calls to monitor suicidal behavior and overall wellbeing.
2 phone calls at 3 and 6 months post-treatment
Trial Site Locations
Total: 9 locations
1
Ch Perrens
Bordeaux, France, France, 33076
Not Yet Recruiting
2
CHU Bicêtre
Le Kremlin-Bicêtre, France, 94270
Actively Recruiting
3
Hospices Civils de Lyon
Lyon, France, 69003
Actively Recruiting
4
CAPPA Jacques PREVERT
Nantes, France, 44000
Actively Recruiting
5
CHU Nîmes
Nîmes, France, 30029
Actively Recruiting
6
CH Sainte-Anne
Paris, France, 75674
Actively Recruiting
7
CH Henri Laborit
Poitiers, France, 86021
Actively Recruiting
8
Chu Toulouse Hopital Purpan
Toulouse, France, 31059
Not Yet Recruiting
9
CHU de Tours
Tours, France, 37540
Actively Recruiting
Research Team
F
Fabrice Jollant, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here