Add-on Buprenorphine At Analgesic Doses for the Treatment of Severe Suicidal Ideas During a Major Depressive Episode

Launched by CENTRE HOSPITALIER UNIVERSITAIRE DE NĪMES · Aug 22, 2018

Keywords

ClinConnect Summary

This clinical trial is studying whether adding a low dose of a medication called buprenorphine to standard treatment can help reduce severe thoughts of suicide in people experiencing a major depressive episode. The goal is to find out if this combination is effective and to determine the best dose of buprenorphine for this purpose.

To be eligible for the study, participants must be between 18 and 65 years old, currently experiencing major depression without psychotic symptoms, and have a significant score on depression and suicidal ideation scales. They need to be either hospitalized or receiving regular medical follow-up and must provide informed consent to join the study. Participants can expect to receive close monitoring and support throughout the trial, as well as the opportunity to contribute to important research aimed at improving treatment for severe depression and suicidal thoughts.

Gender

ALL

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.