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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-512445-17-00
Enrollment
180
Registered
2024-05-07
Start date
2021-07-01
Completion date
Unknown
Last updated
2025-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

mental disorders

Brief summary

Scores on the Scale for Suicidal Ideation (SSI) at Day 7 for the last 7 days

Detailed description

Score on the SSI from D7 to 42 for the last 7 days (except at D2 = for the last 2 days), Psychological pain evaluation by a Visual Analog Scale (PPP-VAS) from D0 to D42 (current and for the last 7 days, except at D2 = for the last 2 days), Scores at the Beck Depression Inventory (BDI-II) and Montgomery-Asberg Depression Rating Scale (MADRS) after excluding the suicidal ideation items, for the last 7 days., Reports of the reasons for discontinuing treatment, Reports of suicide attempts and suicide completion after the treatment phase, Reports of side effects, Reports of withdrawal symptoms, Scores at neuropsychological tests, 3T Magnetic Resonance Imaging measurements, Blood and stool samples collection to create a biobank

Interventions

DRUGBUPRENORPHINE

Sponsors

Centre Hospitalier Universitaire De Nimes
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Scores on the Scale for Suicidal Ideation (SSI) at Day 7 for the last 7 days

Secondary

MeasureTime frame
Score on the SSI from D7 to 42 for the last 7 days (except at D2 = for the last 2 days), Psychological pain evaluation by a Visual Analog Scale (PPP-VAS) from D0 to D42 (current and for the last 7 days, except at D2 = for the last 2 days), Scores at the Beck Depression Inventory (BDI-II) and Montgomery-Asberg Depression Rating Scale (MADRS) after excluding the suicidal ideation items, for the last 7 days., Reports of the reasons for discontinuing treatment, Reports of suicide attempts and suicide completion after the treatment phase, Reports of side effects, Reports of withdrawal symptoms, Scores at neuropsychological tests, 3T Magnetic Resonance Imaging measurements, Blood and stool samples collection to create a biobank

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026