Suicidal IdeationPhase 3BUPRISNCT03646058
Add-on Buprenorphine at Analgesic Doses for the Treatment of Severe Suicidal Ideas During a Major Depressive Episode
A Phase 3 study testing Buprenorphine in people with Suicidal Ideation and Major Depressive Episode, run by Centre Hospitalier Universitaire de Nīmes at 9 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Suicidal Ideation, Major Depressive Episode
- What is being tested?
- Buprenorphine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 9 sitesFrance
- Study dates
- 10 Oct 2021to Jan 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
France9 sites, 9 recruiting
- Not yet recruiting
Ch Perrens
Bordeaux, France, 33076
TOURNIER MARIE, PUPH, 05 56 56 17 71, mtournier@ch-perrens.fr
- Recruiting
CHU Bicêtre
Le Kremlin-Bicêtre, 94270
Emmanuelle Corruble, MD, +33(0)1 45 21 25 24, emmanuelle.corruble@bct.aphp.fr
- Recruiting
Hospices Civils de Lyon
Lyon, 69003
Emmanuel Poulet, MD, +33(0)4 72 11 00 09, emmanuel.poulet@chu-lyon.fr
- Recruiting
CAPPA Jacques PREVERT
Nantes, 44000
Anne Sauvaget, MD, +33(0)2.40.08.47.95, anne.sauvaget@chu-nantes.fr
- Recruiting
CHU Nîmes
Nîmes, 30029
Mocrane Abbar, MD, +33 (0)4.66.68.42.36, m-abbar@chu-nimes.fr
Jorge Lopez Castroman, MD
- Recruiting
CH Sainte-Anne
Paris, 75674
Fabrice Jollant, MD, +33 (0)1 45 55 65 92, fabrice.jollant@parisdescartes.fr
- Recruiting
CH Henri Laborit
Poitiers, 86021
Nemat Jaafari, MD, +33(0)5 16 52 61 18, nemat.jaafari@ch-poitiers.fr
- Not yet recruiting
Chu Toulouse Hopital Purpan
Toulouse, 31059
YRONDI ANTOINE, M.D.,Ph.D., yrondi.a@chu-toulouse.fr
- Recruiting
CHU de Tours
Tours, 37540
Wissam El-Hage, MD, +33(0)2 47 47 80 43, wissam.elhage@univ-tours.fr
About this study
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.
Read the detailed description
Participants will be randomized to two doses of buprenorphine (0.4mg and 0.8mg) or placebo. The duration of treatment will be 21 days with 7 days withdrawal period. Two follow-up phone calls at 3 and 6 months will investigate occurence of suicidal behavior.
The main outcome will be changes in suicidal ideas levels during the first week.
Secondary outcomes will be changes in suicidal ideas during the following 21 days, changes in depression and psychological pain levels over the first 28 days, dropout rates, reasons and occurence of side effects over the first 28 days, withdrawal symptoms dung the withdrawal period, changes in neuropsychological and neuroimaging measures between Day 0 and Day 28.
Blood and stool samples will be collected at 4 time points and stored in a biobank for future analyses.
- Conditions
- Suicidal Ideation, Major Depressive Episode
- Being tested
- Buprenorphine, Placebo
- Keywords
- Treatment, Suicidal ideas, Depression, Buprenorphine, Opioid agonist, Mental pain
- Medical subject headings
- Suicidal Ideation, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BuprenorphineDrug
Also called Temgesic
Buprenorphine, 0.4mg pills, sublingual
PlaceboDrug
Placebo pills, sublingual, specifically made to mimick buprenorphine pills
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 2 placebo pills sublingual during 28 days Receives: 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. Receives: 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. Receives: Drug: Buprenorphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days
Secondary outcomes (19)
Changes in Beck Scale for Suicidal Ideation (SSI) scores
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.
Measured: Day 8 to day 28
Changes in Beck Depression Inventory II (BDI-II) scores from Day 0 to 28
Self questionnaire measuring depression level over the last 7 days; 13 items scored 0 to 3, with the total score ranging from 0 to 39; higher scores mean higher level of depression.
Measured: 28 days
Changes in Montgomery-Asberg Depression Rating Scale (MADRS) from Day 0 to 28
Clinician-based questionnaire measuring the level of depression of the last 7 days; 10 items score 0 to 6, with the total scores ranging fron 0 to 60; Higher scores mean higher level of depression.
Measured: 28 days
Changes in Physical and Psychological Pain - Visual Analog Scale (PPP-VAS) scores from Day 0 to 28
Visual Analog Scale measuring physical then psychological pain over 3 periods each (current, worst over the last 7 days, mean over the last 7 days); 6 dimensions in total; each dimension is scored from 0 (no pain) to 10 (maximal pain).
Measured: 28 days
Reasons for discontinuing treatment over the first 28 days
Patient's self-report; measurement will be the overall (over 28 days) incidence for each event reported.
Measured: 28 days
Side effects over the first 28 days
Patient's self-report; measurement will be the overall (over 28 days) incidence for each event reported.
Measured: 28 days
Withdrawal symptoms
Patient's self-report; measurement will be the incidence of any withdrawal symptom during the withdrawal phase.
Measured: Day 22 to day 28
Occurence of a suicide attempt during the whole study
Interview based; measurement will be the incidence of any suicide attempt between Day 0 and 28, between Day 29 and 90, and between Day 90 and 180.
Measured: 180 days
Changes in Iowa Gambling Task (IGT) scores between Day 0 and 28
Computerized test measuring decision-making; scores are the difference between advantageous and disadvantageous choices; scores range from -100 to + 100, higher scores means better performance
Measured: 28 days
Changes in modified Stroop test scores between Day 0 and 28
Classical Stroop test modified with suicide-related words to measure specific attention bias; scores are the number of errors and total reaction time; higher scores mean worse performance
Measured: 28 days
Changes in verbal fluency test scores between Day 0 and 28
Classical test measuring verbal fluency skills for semantic and phonological categories; Patients are instructed to give as many words as possible for a given category then for words starting with a given letter, within a 1 minute time frame; Scores are the number of correct words; higher scores mean higher performance
Measured: 28 days
Changes in N-Back test scores between Day 0 and 28
Classical test of working memory using letters; scores are the number of words correctly identified for each level of recall (0 to 2 back); higher scores mean better performance; also, the number of omission and commission errors.
Measured: 28 days
Changes in Go/No-Go test between Day 0 and 28
Classical test of cognitive inhibition, letter version; scores are the number of omission and commission errors (higher scores mean worse performance) and reaction times (higher scores mean better performance)
Measured: 28 days
Changes in Trail Making Test (TMT) scores between Day 0 and 28
Classical test of planning abilities; scores are the difference between the time to complete parts B and A of the test; Higher scores mean worse performance.
Measured: 28 days
Changes in Implicit Association Test (IAT) scores between Day 0 and 28
IAT version adapted for suicide/death; scores are the measure of reaction times in the association between suicide/death words and me/myself words; lower scores mean higher association.
Measured: 28 days
Changes in Magnetic Resonance Imaging (MRI) T1 measures between Day 0 and 28
Brain structural MRI-T1 sequence measured at Day 0 and Day 28 (5 minutes)
Measured: 28 days
Changes in Magnetic Resonance Imaging (MRI) T2 measures between Day 0 and 28
Brain structural MRI-T2 sequence measured at Day 0 and Day 28 (5 minutes)
Measured: 28 days
Changes in Magnetic Resonance Imaging (MRI) Diffusion Tensor Imaging (DTI) measures between Day 0 and 28
Brain Diffusion Tensor Imaging (DTI) sequence measured at Day 0 and Day 28 (20 minutes)
Measured: 28 days
Changes in Magnetic Resonance Imaging (MRI) Resting State (RS) measures between Day 0 and 28
Brain functional Resting State (RS) sequence measured at Day 0 and Day 28 (15 minutes)
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2018
- Study start10 Oct 2021
- Primary completionOct 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicidal IdeationStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabrice Jollant, MD, Principal investigator, Hôpital Sainte-Anne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03646058
- Sponsor's protocol ID
- PHRC-N/2017/FJ-01
- Acronym
- BUPRIS
- Status last verified
- Aug 2025
- First submitted
- 16 Aug 2018
- Last updated
- 21 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Add-on Buprenorphine at Analgesic Doses for the Treatment of Severe Suicidal Ideas During a Major Depressive Episode
- ClinicalTrials.gov ID
- NCT03646058
- Acronym / sponsor ID
- BUPRIS / PHRC-N/2017/FJ-01
- Conditions
- Suicidal Ideation, Major Depressive Episode
- Keywords
- Treatment, Suicidal ideas, Depression, Buprenorphine, Opioid agonist, Mental pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 10 Oct 2021 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 24 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Participants will be randomized to two doses of buprenorphine (0.4mg and 0.8mg) or placebo. The duration of treatment will be 21 days with 7 days withdrawal period. Two follow-up phone calls at 3 and 6 months will investigate occurence of suicidal behavior.
The main outcome will be changes in suicidal ideas levels during the first week.
Secondary outcomes will be changes in suicidal ideas during the following 21 days, changes in depression and psychological pain levels over the first 28 days, dropout rates, reasons and occurence of side effects over the first 28 days, withdrawal symptoms dung the withdrawal period, changes in neuropsychological and neuroimaging measures between Day 0 and Day 28.
Blood and stool samples will be collected at 4 time points and stored in a biobank for future analyses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo2 placebo pills sublingual during 28 days |
| 0.4mg buprenorphine | Experimental | Drug: Buprenorphine1 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. |
| 0.8mg buprenorphine | Experimental | Drug: Buprenorphine1 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BuprenorphineAlso: TemgesicBuprenorphine, 0.4mg pills, sublingual | Drug | 0.4mg buprenorphine, 0.8mg buprenorphine |
| PlaceboPlacebo pills, sublingual, specifically made to mimick buprenorphine pills | Drug | Placebo |
Primary outcome
Changes in Beck Scale for Suicidal Ideation (SSI) scores from Day 0 to 7
Time frame: 7 days
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.
19 secondary outcomes
Changes in Beck Scale for Suicidal Ideation (SSI) scores
Time frame: Day 8 to day 28
Changes in Beck Depression Inventory II (BDI-II) scores from Day 0 to 28
Time frame: 28 days
Changes in Montgomery-Asberg Depression Rating Scale (MADRS) from Day 0 to 28
Time frame: 28 days
Changes in Physical and Psychological Pain - Visual Analog Scale (PPP-VAS) scores from Day 0 to 28
Time frame: 28 days
Reasons for discontinuing treatment over the first 28 days
Time frame: 28 days
Side effects over the first 28 days
Time frame: 28 days
Withdrawal symptoms
Time frame: Day 22 to day 28
Occurence of a suicide attempt during the whole study
Time frame: 180 days
Changes in Iowa Gambling Task (IGT) scores between Day 0 and 28
Time frame: 28 days
Changes in modified Stroop test scores between Day 0 and 28
Time frame: 28 days
Changes in verbal fluency test scores between Day 0 and 28
Time frame: 28 days
Changes in N-Back test scores between Day 0 and 28
Time frame: 28 days
Changes in Go/No-Go test between Day 0 and 28
Time frame: 28 days
Changes in Trail Making Test (TMT) scores between Day 0 and 28
Time frame: 28 days
Changes in Implicit Association Test (IAT) scores between Day 0 and 28
Time frame: 28 days
Changes in Magnetic Resonance Imaging (MRI) T1 measures between Day 0 and 28
Time frame: 28 days
Changes in Magnetic Resonance Imaging (MRI) T2 measures between Day 0 and 28
Time frame: 28 days
Changes in Magnetic Resonance Imaging (MRI) Diffusion Tensor Imaging (DTI) measures between Day 0 and 28
Time frame: 28 days
Changes in Magnetic Resonance Imaging (MRI) Resting State (RS) measures between Day 0 and 28
Time frame: 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fabrice Jollant, MD principal investigator
Hôpital Sainte-Anne
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Buprenorphine in people with Suicidal Ideation and Major Depressive Episode, run by Centre Hospitalier Universitaire de Nīmes at 9 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fabrice Jollant, MD (+33(0)1 45 65 85 72, fabrice.jollant@parisdescartes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Beck Scale for Suicidal Ideation (SSI) scores from Day 0 to 7 (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2025.