NCT03646058 (BUPRIS) is a Phase 3 clinical trial of Buprenorphine in Suicidal Ideation, sponsored by Centre Hospitalier Universitaire de Nīmes.

Who is sponsoring NCT03646058?

NCT03646058 is sponsored by Centre Hospitalier Universitaire de Nīmes.

What drugs are being tested in NCT03646058?

Interventions in NCT03646058: Buprenorphine, Placebo.

What condition does NCT03646058 study?

NCT03646058 studies Suicidal Ideation, Major Depressive Episode.

Is NCT03646058 still recruiting?

NCT03646058 is currently recruiting now. Last updated 19 August 2025.

Last reviewed 2025-08-19 · How we verify

NCT03646058: BUPRIS

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Recruiting now Phase 3 Last updated 19 August 2025

What this trial tests

Phase 3 trial testing Buprenorphine in Suicidal Ideation in 180 participants. Currently enrolling.

Timeline

10 October 2021

Primary endpoint
1 October 2026

1 January 2027

Quick facts

Lead sponsor	Centre Hospitalier Universitaire de Nīmes
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	180
Start date	10 October 2021
Primary completion	1 October 2026
Estimated completion	1 January 2027
Sites	9 locations across France

Drugs / interventions tested

Buprenorphine (BUPRENORPHINE) — full drug profile →
Placebo

Conditions studied

Suicidal Ideation — all drugs for Suicidal Ideation →
Major Depressive Episode — all drugs for Major Depressive Episode →

Sponsor

Centre Hospitalier Universitaire de Nīmes

Who can join

Adults 18 to 65, any sex, with Suicidal Ideation or Major Depressive Episode. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Changes in Beck Scale for Suicidal Ideation (SSI) scores from Day 0 to 7
Time frame: 7 days
Clinician-based questionnaire measuring level of suicidal ideas over the last 7 days; 21 items scored 0 to 2; total score ranges from 0 to 38 (last 2 items not counted), higher scores mean more intense suicidal ideas.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

The efficacy and safety of buprenorphine for the treatment of depression: A systematic review and meta-analysis.
Riblet NB, Young-Xu Y, Shiner B, Schnurr PP, et al · · 2023 · cited 8× · PMID 37019069 · DOI 10.1016/j.jpsychires.2023.03.037
Emerging Medications for Treatment-Resistant Depression: A Review with Perspective on Mechanisms and Challenges.
Lucido MJ, Dunlop BW. · · 2025 · cited 7× · PMID 40002494 · DOI 10.3390/brainsci15020161

Verify or expand the search:

Other trials of Buprenorphine

Trials testing the same drug.

NCT06379984 — Rapid Outpatient Low-dose Initiation of Buprenorphine for OUD With Fentanyl Use · Phase 2 · recruiting
NCT06316830 — Identifying Optimal Buprenorphine Dosing for Opioid Use Disorder Treatment and Prevention of Overdose · Phase 2, PHASE3 · recruiting
NCT06086275 — Oral Buprenorphine as a Novel Low-dose Induction Strategy for Opioid Use Disorder · Phase 1 · completed
NCT06406400 — Drug-Drug Interaction and Safety of AZD4041 Study (Part 1) and Efficacy, Safety, Pharmacokinetics and Pharmacodynamics o · Phase 1 · terminated
NCT06008990 — Maternal Brain Imaging in Opioid Use Disorder · active not recruiting

Other recruiting trials for Suicidal Ideation

Currently open trials in the same condition.

NCT07438912 — Mind After Midnight · NA · recruiting
NCT07238192 — Augmenting Massed Cognitive Processing Therapy (CPT) to Prevent Suicide Risk Among Patients With PTSD · NA · recruiting
NCT07217444 — Improving Outcomes in Adolescent Inpatient Depression With Deep Transcranial Magnetic Stimulation · NA · recruiting
NCT07259408 — Co-creation of Tools for People in Detention With Suicidal Thoughts and/or Behavior · recruiting
NCT07305701 — Cohort Study on Medical Students' Mental Health · recruiting

Other Centre Hospitalier Universitaire de Nīmes trials

Trials by the same sponsor.

NCT07403474 — Combined Use of a Respiratory Multiplex PCR and Algorithm-based Therapy to Improve Early Optimization of Antibiotic Ther · Phase 4 · not yet recruiting
NCT07455981 — Work Organization and Gambling Addiction · not yet recruiting
NCT07403500 — Evaluation of the Short-term Effectiveness of Spinal Manipulation to Treat Acute and Subacute Low Back Pain. · NA · not yet recruiting
NCT07342010 — Bicarbonate Addition to Lidocaine-Epinephrine in Surgery Under WALANT · Phase 4 · not yet recruiting
NCT07305727 — A Radiomic MRI Predictive Model for Response to Concomitant Chemoradiotherapy in Locally Advanced Cervical Cancer · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03646058 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Centre Hospitalier Universitaire de Nīmes
Last refreshed: 19 August 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03646058.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing