Add-on Buprenorphine at Analgesic Doses for the Treatment of Severe Suicidal Ideas During a Major Depressive Episode
NCT03646058, Phase 3, Recruiting, Centre Hospitalier Universitaire de Nīmes
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Add-on Buprenorphine at Analgesic Doses for the Treatment of Severe Suicidal Ideas During a Major Depressive Episode | ClinicalTrials.gov |
| NCT number | NCT03646058 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Phase 3 | ClinicalTrials.gov |
| Enrollment | 180 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Centre Hospitalier Universitaire de Nīmes | ClinicalTrials.gov |
| Conditions | Suicidal Ideation, Major Depressive Episode | ClinicalTrials.gov |
| Interventions | Buprenorphine, Placebo | ClinicalTrials.gov |
| First posted | 2018-08-24 | ClinicalTrials.gov |
| Last updated | 2025-08-21 | ClinicalTrials.gov |
Registered outcomes 20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Changes in Beck Scale for Suicidal Ideation (SSI) scores from Day 0 to 7 | 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. | ClinicalTrials.gov |
| Secondary | Changes in Beck Scale for Suicidal Ideation (SSI) scores | Day 8 to day 28 | 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. | ClinicalTrials.gov |
| Secondary | Changes in Beck Depression Inventory II (BDI-II) scores from Day 0 to 28 | 28 days | Self questionnaire measuring depression level over the last 7 days; 13 items scored 0 to 3, with the total score ranging from 0 to 39; higher scores mean higher level of depression. | ClinicalTrials.gov |
| Secondary | Changes in Montgomery-Asberg Depression Rating Scale (MADRS) from Day 0 to 28 | 28 days | Clinician-based questionnaire measuring the level of depression of the last 7 days; 10 items score 0 to 6, with the total scores ranging fron 0 to 60; Higher scores mean higher level of depression. | ClinicalTrials.gov |
| Secondary | Changes in Physical and Psychological Pain - Visual Analog Scale (PPP-VAS) scores from Day 0 to 28 | 28 days | Visual Analog Scale measuring physical then psychological pain over 3 periods each (current, worst over the last 7 days, mean over the last 7 days); 6 dimensions in total; each dimension is scored from 0 (no pain) to 10 (maximal pain). | ClinicalTrials.gov |
| Secondary | Reasons for discontinuing treatment over the first 28 days | 28 days | Patient's self-report; measurement will be the overall (over 28 days) incidence for each event reported. | ClinicalTrials.gov |
| Secondary | Side effects over the first 28 days | 28 days | Patient's self-report; measurement will be the overall (over 28 days) incidence for each event reported. | ClinicalTrials.gov |
| Secondary | Withdrawal symptoms | Day 22 to day 28 | Patient's self-report; measurement will be the incidence of any withdrawal symptom during the withdrawal phase. | ClinicalTrials.gov |
| Secondary | Occurence of a suicide attempt during the whole study | 180 days | Interview based; measurement will be the incidence of any suicide attempt between Day 0 and 28, between Day 29 and 90, and between Day 90 and 180. | ClinicalTrials.gov |
| Secondary | Changes in Iowa Gambling Task (IGT) scores between Day 0 and 28 | 28 days | Computerized test measuring decision-making; scores are the difference between advantageous and disadvantageous choices; scores range from -100 to + 100, higher scores means better performance | ClinicalTrials.gov |
| Secondary | Changes in modified Stroop test scores between Day 0 and 28 | 28 days | Classical Stroop test modified with suicide-related words to measure specific attention bias; scores are the number of errors and total reaction time; higher scores mean worse performance | ClinicalTrials.gov |
| Secondary | Changes in verbal fluency test scores between Day 0 and 28 | 28 days | Classical test measuring verbal fluency skills for semantic and phonological categories; Patients are instructed to give as many words as possible for a given category then for words starting with a given letter, within a 1 minute time frame; Scores are the number of correct words; higher scores mean higher performance | ClinicalTrials.gov |
| Secondary | Changes in N-Back test scores between Day 0 and 28 | 28 days | Classical test of working memory using letters; scores are the number of words correctly identified for each level of recall (0 to 2 back); higher scores mean better performance; also, the number of omission and commission errors. | ClinicalTrials.gov |
| Secondary | Changes in Go/No-Go test between Day 0 and 28 | 28 days | Classical test of cognitive inhibition, letter version; scores are the number of omission and commission errors (higher scores mean worse performance) and reaction times (higher scores mean better performance) | ClinicalTrials.gov |
| Secondary | Changes in Trail Making Test (TMT) scores between Day 0 and 28 | 28 days | Classical test of planning abilities; scores are the difference between the time to complete parts B and A of the test; Higher scores mean worse performance. | ClinicalTrials.gov |
| Secondary | Changes in Implicit Association Test (IAT) scores between Day 0 and 28 | 28 days | IAT version adapted for suicide/death; scores are the measure of reaction times in the association between suicide/death words and me/myself words; lower scores mean higher association. | ClinicalTrials.gov |
| Secondary | Changes in Magnetic Resonance Imaging (MRI) T1 measures between Day 0 and 28 | 28 days | Brain structural MRI-T1 sequence measured at Day 0 and Day 28 (5 minutes) | ClinicalTrials.gov |
| Secondary | Changes in Magnetic Resonance Imaging (MRI) T2 measures between Day 0 and 28 | 28 days | Brain structural MRI-T2 sequence measured at Day 0 and Day 28 (5 minutes) | ClinicalTrials.gov |
| Secondary | Changes in Magnetic Resonance Imaging (MRI) Diffusion Tensor Imaging (DTI) measures between Day 0 and 28 | 28 days | Brain Diffusion Tensor Imaging (DTI) sequence measured at Day 0 and Day 28 (20 minutes) | ClinicalTrials.gov |
| Secondary | Changes in Magnetic Resonance Imaging (MRI) Resting State (RS) measures between Day 0 and 28 | 28 days | Brain functional Resting State (RS) sequence measured at Day 0 and Day 28 (15 minutes) | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 9
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| 1-Back Task | Secondary outcome | ConductCognition |
| 2-Back Task | Secondary outcome | ConductCognition |
| Go/No-Go Task | Secondary outcome | ConductCognition |
| Implicit Association Test (IAT) | Secondary outcome | ConductCognition |
| Iowa Gambling Lite | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
| Verbal Fluency | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)