Add-on buprenorphine at analgesic doses for the treatment of severe suicidal ideas during a major depressive episode

Phase 1

• Conditions: mental disorders; MedDRA version: 23.0Level: LLTClassification code: 10083288Term: Clinical depression Class: 10037175; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: CTIS2024-512445-17-00
• Lead Sponsor: Centre Hospitalier Universitaire De Nimes

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-07
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

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.

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified