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

Who is this study for? Patients with Major Depressive Disorder With Suicidal Ideation
What treatments are being studied? Buprenorphine
Status: Recruiting
Location: See all (9) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
Ch Perrens
NOT_YET_RECRUITING
Bordeaux
CHU Bicêtre
RECRUITING
Le Kremlin-bicêtre
Hospices Civils de Lyon
RECRUITING
Lyon
CAPPA Jacques PREVERT
RECRUITING
Nantes
CHU Nîmes
RECRUITING
Nîmes
CH Sainte-Anne
RECRUITING
Paris
CH Henri Laborit
RECRUITING
Poitiers
Chu Toulouse Hopital Purpan
NOT_YET_RECRUITING
Toulouse
CHU de Tours
RECRUITING
Tours
Contact Information
Primary
Fabrice Jollant, MD
fabrice.jollant@parisdescartes.fr
+33(0)1 45 65 85 72
Time Frame
Start Date: 2021-10-10
Estimated Completion Date: 2026-01
Participants
Target number of participants: 180
Treatments
Placebo_comparator: Placebo
2 placebo pills sublingual during 28 days
Experimental: 0.4mg buprenorphine
1 pill of 0.4 mg buprenorphine + 1 placebo pill per day for 21 days, then 2 placebo pills per day for 1 week, all sublingual.
Experimental: 0.8mg buprenorphine
1 pill of 0.4 mg buprenorphine + 1 placebo pill per day for 3 days, then 2 pills of 0.4mg buprenorphine per day for 18 days, then 1 pill of 0.4 mg + 1 placebo pill per day for 3 days, then 2 placebo pills per day for 4 days, all sublingual.
Sponsors
Leads: Centre Hospitalier Universitaire de Nīmes

This content was sourced from clinicaltrials.gov