NCT03646058 Add-on Buprenorphine at Analgesic Doses for the Treatment of Severe Suicidal Ideas During a Major Depressive Episode
| NCT ID | NCT03646058 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Centre Hospitalier Universitaire de Nīmes |
| Condition | Suicidal Ideation |
| Study Type | INTERVENTIONAL |
| Enrollment | 180 participants |
| Start Date | 2021-10-10 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 180 participants in total. It began in 2021-10-10 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Fabrice Jollant, MD
PRINCIPAL INVESTIGATOR
Hôpital Sainte-Anne
Frequently Asked Questions
Who can join the NCT03646058 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Suicidal Ideation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03646058 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 180 participants.
Is NCT03646058 currently recruiting?
Yes, NCT03646058 is actively recruiting participants. Contact the research team at fabrice.jollant@parisdescartes.fr for enrollment information.
Where is the NCT03646058 trial being conducted?
This trial is being conducted at Bordeaux, France, Le Kremlin-Bicêtre, France, Lyon, France, Nantes, France and 5 additional locations.
Who is sponsoring the NCT03646058 clinical trial?
NCT03646058 is sponsored by Centre Hospitalier Universitaire de Nīmes. The principal investigator is Fabrice Jollant, MD at Hôpital Sainte-Anne. The trial plans to enroll 180 participants.