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Add-on buprenorphine at analgesic doses for the treatment of severe suicidal ideas during a major depressive episode
EU CTIS ID: 2024-512445-17-00
What this study is testing
To show a significant effect of buprenorphine vs. placebo for the treatment of suicidal ideas at D7, and assess the most effective dosage (0.8mg vs. 0.4mg) of buprenorphine.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- The patient is a man or a woman aged at least 18 years old and 65 years old at the most.
- The patient is hospitalized
- The patient suffers from a current major depressive episode without psychotic features according to DSM-5 criteria and a Montgomery-Asberg Depression Rating Scale (MADRS) score > 20, as part of a bipolar or major depressive disorder.
- The patient has a current Scale for Suicidal Ideation (SSI) score > 8.
- The patient must have given his/her informed and signed consent.
- The patient must be insured or beneficiary of a health insurance plan.
You likely can't join if
- The patient is participating in another interventional trial;
- 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 has received Electroconvulsivotherapy (ECT) over the last 3 months.
- The patient currently suffers from severe and/or unstable medical condition (including severe respiratory, renal or hepatic insufficiency) or a painful medical condition;
- The patient has a current known sleep apnea.
- The patient has a severe renal impairment
See the full eligibility criteria
Who can join
- The patient is a man or a woman aged at least 18 years old and 65 years old at the most.
- The patient is hospitalized
- The patient suffers from a current major depressive episode without psychotic features according to DSM-5 criteria and a Montgomery-Asberg Depression Rating Scale (MADRS) score > 20, as part of a bipolar or major depressive disorder.
- The patient has a current Scale for Suicidal Ideation (SSI) score > 8.
- The patient must have given his/her informed and signed consent.
- The patient must be insured or beneficiary of a health insurance plan.
What rules you out
- The patient is participating in another interventional trial;
- 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 has received Electroconvulsivotherapy (ECT) over the last 3 months.
- The patient currently suffers from severe and/or unstable medical condition (including severe respiratory, renal or hepatic insufficiency) or a painful medical condition;
- The patient has a current known sleep apnea.
- The patient has a severe renal impairment
- The patient currently takes analgesic treatment (incl. NSAID and paracetamol);
- The patient takes central nervous depressant drugs at sedative doses (based on the investigator’s assessment), including sedative antidepressants, benzodiazepines, antihistamines, and sedative antipsychotics;
- The patient receives major CYP3A4 Inhibitors and inducers medication;
- Contra-indications mentioned for in SCP (Summary of product characteristics) of buprénorphine.
- Use of alcohol or medication containing alcohol
- The patient is in an exclusion period determined by a previous study;
- Patient receives a Monoamine Oxydase Inhibitor (MAOI) antidepressant
- Contra-indications mentioned in SCP (Summary of product characteristics) of buprénorphine and in particular Hypersensitivity to the active substance or to any of the excipients mentioned in section 6.1. of the SCP
- Contra-indications mentioned in SCP (Summary of product characteristics) of buprénorphine and in particular Severe respiratory insufficiency (Altered respiratory function due to any medical condition (e.g chronic obstructive pulmonary disease, asthma, hypoxia, hypercapnia, pre-exisiting respiratory depression)
- Contra-indications mentioned in SCP (Summary of product characteristics) of buprénorphine and in particular Severe hepatic insufficiency
- Contra-indications mentioned in SCP (Summary of product characteristics) of buprénorphine and in particular Acute alcohol poisoning or delirium tremens.
- Contra-indications mentioned in SCP (Summary of product characteristics) of buprénorphine and in particular Combination with méthadone, level III morphinic painkillers, naltrexone, and nalméfène.
- 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 actively followed in consultation
- The patient is pregnant or breastfeeding.
- The patient suffers from schizophrenia
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.