Add-on buprenorphine for the treatment of severe suicidal ideas

Phase 1

Active, not recruiting

• Conditions: Treatment of severe suicidal ideas in patients suffers from a current major depressive episode; MedDRA version: 23.0Level: LLTClassification code 10083288Term: Clinical depressionSystem Organ Class: 100000004873; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2018-003816-38-FR
• Lead Sponsor: CHU DE NIMES

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-12
• Last Update Posted: 21 May 2024

Recruitment & Eligibility

• Status: Not 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 or actively followed in consultation.
•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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80

Exclusion Criteria

•The patient is participating in another interventional trial;
•or is in an exclusion period determined by a previous study;
•or is under judicial protection, or is an adult under guardianship;
•or is under compulsory admission;
•or refuses to sign the consent;
•or it is impossible to correctly inform the patient.
•The patient is pregnant or breastfeeding.
•The patient suffers from schizophrenia;
•The patient has a lifetime history of substance use disorder (except tobacco and caffeine) alcohol or benzodiazepine use disorder 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 or hepatic insufficiency) or a painful medical condition;
•The patient has a current known sleep apnea.
•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 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.

Study & Design

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