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

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ClinicalTrials.gov Identifier: NCT03646058
Recruitment Status : Not yet recruiting
First Posted : August 24, 2018
Last Update Posted : August 24, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

Brief 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.

Condition or disease Intervention/treatment Phase
Suicidal Ideation Major Depressive Episode Drug: Buprenorphine Drug: Placebo Phase 3

Detailed Description:

Participants will be randomized to two doses of buprenorphine (0.4mg and 0.8mg) or placebo. The duration of treatment will be 21 days with 7 days withdrawal period. Two follow-up phone calls at 3 and 6 months will investigate occurence of suicidal behavior.

The main outcome will be changes in suicidal ideas levels during the first week.

Secondary outcomes will be changes in suicidal ideas during the following 21 days, changes in depression and psychological pain levels over the first 28 days, dropout rates, reasons and occurence of side effects over the first 28 days, withdrawal symptoms dung the withdrawal period, changes in neuropsychological and neuroimaging measures between Day 0 and Day 28.

Blood and stool samples will be collected at 4 time points and stored in a biobank for future analyses.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Add-on Buprenorphine at Analgesic Doses for the Treatment of Severe Suicidal Ideas During a Major Depressive Episode
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

Arm Intervention/treatment
Placebo Comparator: Placebo
2 placebo pills sublingual during 28 days
Drug: Placebo
Placebo pills, sublingual, specifically made to mimick buprenorphine pills

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.
Drug: Buprenorphine
Buprenorphine, 0.4mg pills, sublingual
Other Name: Temgesic

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.
Drug: Buprenorphine
Buprenorphine, 0.4mg pills, sublingual
Other Name: Temgesic




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Changes in Beck Scale for Suicidal Ideation (SSI) scores [ Time Frame: 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.

  2. Changes in Beck Depression Inventory II (BDI-II) scores from Day 0 to 28 [ Time Frame: 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.

  3. Changes in Montgomery-Asberg Depression Rating Scale (MADRS) from Day 0 to 28 [ Time Frame: 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.

  4. Changes in Physical and Psychological Pain - Visual Analog Scale (PPP-VAS) scores from Day 0 to 28 [ Time Frame: 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).

  5. Reasons for discontinuing treatment over the first 28 days [ Time Frame: 28 days ]
    Patient's self-report; measurement will be the overall (over 28 days) incidence for each event reported.

  6. Side effects over the first 28 days [ Time Frame: 28 days ]
    Patient's self-report; measurement will be the overall (over 28 days) incidence for each event reported.

  7. Withdrawal symptoms [ Time Frame: Day 22 to day 28 ]
    Patient's self-report; measurement will be the incidence of any withdrawal symptom during the withdrawal phase.

  8. Occurence of a suicide attempt during the whole study [ Time Frame: 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.

  9. Changes in Iowa Gambling Task (IGT) scores between Day 0 and 28 [ Time Frame: 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

  10. Changes in modified Stroop test scores between Day 0 and 28 [ Time Frame: 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

  11. Changes in verbal fluency test scores between Day 0 and 28 [ Time Frame: 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

  12. Changes in N-Back test scores between Day 0 and 28 [ Time Frame: 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.

  13. Changes in Go/No-Go test between Day 0 and 28 [ Time Frame: 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)

  14. Changes in Trail Making Test (TMT) scores between Day 0 and 28 [ Time Frame: 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.

  15. Changes in Implicit Association Test (IAT) scores between Day 0 and 28 [ Time Frame: 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.

  16. Changes in Magnetic Resonance Imaging (MRI) T1 measures between Day 0 and 28 [ Time Frame: 28 days ]
    Brain structural MRI-T1 sequence measured at Day 0 and Day 28 (5 minutes)

  17. Changes in Magnetic Resonance Imaging (MRI) T2 measures between Day 0 and 28 [ Time Frame: 28 days ]
    Brain structural MRI-T2 sequence measured at Day 0 and Day 28 (5 minutes)

  18. Changes in Magnetic Resonance Imaging (MRI) Diffusion Tensor Imaging (DTI) measures between Day 0 and 28 [ Time Frame: 28 days ]
    Brain Diffusion Tensor Imaging (DTI) sequence measured at Day 0 and Day 28 (20 minutes)

  19. Changes in Magnetic Resonance Imaging (MRI) Resting State (RS) measures between Day 0 and 28 [ Time Frame: 28 days ]
    Brain functional Resting State (RS) sequence measured at Day 0 and Day 28 (15 minutes)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • The patient is participating in another interventional trial;
  • The patient is in an exclusion period determined by a previous study;
  • The patient is under judicial protection, or is an adult under guardianship;
  • The patient is under compulsory admission;
  • The patient refuses to sign the consent;
  • 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), moderate to severe, according to criteria of the "Diagnostic and Statistical Manual of Mental Disorders";
  • 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 (including Nonsteroidal anti-inflammatory drug and paracetamol);
  • The patient currently takes central nervous depressant drugs at sedative doses (based on the investigator's assessment), including benzodiazepines, antihistamines, and sedative antipsychotics;
  • The patient currently takes major CYP3A4 Inhibitors and inducers;
  • The patient currently takes has received Electroconvulsivotherapy over the last 3 months.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03646058


Contacts
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Contact: Fabrice Jollant, MD +33(0)1 45 65 85 72 fabrice.jollant@parisdescartes.fr

Locations
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France
CHRU Hôpital Saint-Jacques Not yet recruiting
Besançon, France, 25030
Contact: Emmanuel Haffen, MD    +33(0)3 81 21 81 54    emmanuel.haffen@univ-fcomte.fr   
Sub-Investigator: Djamila Bennabi, MD         
CHU Grenoble Alpes Not yet recruiting
La Tronche, France, 38700
Contact: Mircea Polosan, MD    +33(0)4 76 76 87 10    MPolosan@chu-grenoble.fr   
CHU Bicêtre Not yet recruiting
Le Kremlin-Bicêtre, France, 94270
Contact: Emmanuelle Corruble, MD    +33(0)1 45 21 25 24    emmanuelle.corruble@bct.aphp.fr   
Hospices Civils de Lyon Not yet recruiting
Lyon, France, 69003
Contact: Emmanuel Poulet, MD    +33(0)4 72 11 00 09    emmanuel.poulet@chu-lyon.fr   
Sub-Investigator: Charlotte Brevet-Aeby, MD         
Sub-Investigator: Clémence Bied, MD         
Sub-Investigator: Delphine Ragonnet, MD         
CHU Lapeyronie Not yet recruiting
Montpellier, France, 34295
Contact: Philippe Courtet, MD    +33(0)4 67 33 85 81    p-courtet@chu-montpellier.fr   
Sub-Investigator: Emilie Olié, MD         
CAPPA Jacques PREVERT Not yet recruiting
Nantes, France, 44000
Contact: Anne Sauvaget, MD    +33(0)2.40.08.47.95    anne.sauvaget@chu-nantes.fr   
Clinique Les Sophoras Not yet recruiting
Nîmes, France, 30000
Contact: Stéphane Torres, MD    +33(0)4 66 62 79 00    stmx@free.fr   
Sub-Investigator: Guillaume Collin, MD         
CHU Nîmes Not yet recruiting
Nîmes, France, 30029
Contact: Mocrane Abbar, MD    +33 (0)4.66.68.42.36    m-abbar@chu-nimes.fr   
Sub-Investigator: Jorge Lopez Castroman, MD         
Sub-Investigator: Ismaël Conegero, MD         
CH Sainte-Anne Not yet recruiting
Paris, France, 75674
Contact: Fabrice Jollant, MD    +33 (0)1 45 55 65 92    fabrice.jollant@parisdescartes.fr   
Sub-Investigator: Isabelle Roy, MD         
Sub-Investigator: Guillaume Pineau, MD         
Sub-Investigator: Yann Mongin, MD         
Sub-Investigator: Philip Gorwood, MD         
CH Henri Laborit Not yet recruiting
Poitiers, France, 86021
Contact: Nemat Jaafari, MD    +33(0)5 16 52 61 18    nemat.jaafari@ch-poitiers.fr   
CHU de Tours Not yet recruiting
Tours, France, 37540
Contact: Wissam El-Hage, MD    +33(0)2 47 47 80 43    wissam.elhage@univ-tours.fr   
Sub-Investigator: Mathieu Lemaire, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
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Principal Investigator: Fabrice Jollant, MD Hôpital Sainte-Anne

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Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT03646058     History of Changes
Other Study ID Numbers: PHRC-N/2017/FJ-01
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: August 24, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre Hospitalier Universitaire de Nīmes:
Treatment
Suicidal ideas
Depression
Buprenorphine
Opioid agonist
Mental pain

Additional relevant MeSH terms:
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Suicidal Ideation
Depression
Depressive Disorder
Depressive Disorder, Major
Suicide
Self-Injurious Behavior
Behavioral Symptoms
Mood Disorders
Mental Disorders
Analgesics
Buprenorphine
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Narcotic Antagonists