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Suicide Attempts and Tramadol : a Case Report

Sponsor
University Hospital, Montpellier (Other)
Overall Status
Completed
CT.gov ID
NCT05075291
Collaborator
(none)
1
Enrollment
1
Location
8.9
Actual Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In France, over the last years the use weak opioid analgesics decreased́, whereas that of strong opioid analgesics (OFMA). Hospitalizations for opioid overdose increased́ by 128% from 2000 to 2015, and deaths related to prescribed opioid overdose increased significantly, by 161%, from 2000 to 2014.In addition, recent studies suggest a link between opioid system dysfunction and suicidal behavior.

In parallel, studies are emerging showing the potential interest of using Tramadol as an antidepressant. Indeed, this opiate analgesic also acts on the serotonergic and dopaminergic systems, and would have an antidepressant effect.Thus, the investigators can legitimately wonder whether the use of Tramadol as an antidepressant might not pose a problem in patients at risk of suicide.

This study aims to describe a clinical case of a patient hospitalized in the Department of Psychiatric Emergency and Post-Emergency (Montpellier University Hospital) who developed a severe addiction to Tramadol (consumption up to 5 times the maximum recommended dose per day) and evaluate whether this may have increased her suicidal risk, in order to warn prescribers about the suicidal risk of Tramadol.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    1 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    Repeated Suicide Attempts in a Patient Suffering From Addiction to Tramadol: a Case Report
    Actual Study Start Date :
    Nov 1, 2020
    Actual Primary Completion Date :
    Nov 1, 2020
    Actual Study Completion Date :
    Jul 30, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Lifetime suicidal events [day 1]

      Occurrence of suicidal events (actuel, interrupted and aborted or self-aborted suicide attempts) based on the patient medical records.

    Secondary Outcome Measures

    1. Depressive symptomatology [day 1]

      Depressive symptomatology assessed with the Montgomery Asberg Depression Rating Scale (MADRS). The total score ranges from 0 to 60 : scores between 0 and 6 : no depression, scores between 7 and 19 : mild depression, scores between 20 and 34 : moderate depression scores above 34 : severe depression

    2. Suicidal ideation [day 1]

      Suicidal thoughts assessed with the Columbia Suicide Severity Scale (C-SSRS). The suicidal ideation severity subscale ranges from 1 to 5 (with higher number indicating more severe ideation). The intensity of ideation subscale includes 5 questions each one ranging from 1 to 5 (with higher number indicating more intense ideation). The suicidal behavior subscale includes 4 yes/no questions. The suicidal behavior lethality subscale inquires about the level of actual or potential medical damage.

    3. Psychological pain [day 1]

      Psychological pain assessed with a Likert scale : Strongly disagree, Disagree, Neutral, Agree, Strongly agree

    4. Anxiety [day 1]

      Anxiety level assessed with a Likert scale : Strongly disagree, Disagree, Neutral, Agree, Strongly agree

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion criteria:

    • Multiple suicide attempts

    • Tramadol addiction

    NA : patient case report

    Exclusion criteria:
    • None

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Uhmontpellier Montpellier France 34295

    Sponsors and Collaborators

    • University Hospital, Montpellier

    Investigators

    • Principal Investigator: Bénédicte NOBILE, PharmD, PhD, University Hospital, Montpellier

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Montpellier
    ClinicalTrials.gov Identifier:
    NCT05075291
    Other Study ID Numbers:
    • RECHMPL21_0571
    First Posted:
    Oct 12, 2021
    Last Update Posted:
    Oct 12, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Montpellier
    Suicide
    Addiction
    Opioids
    Additional relevant MeSH terms:
    Behavior, Addictive
    Suicide
    Suicide, Attempted

    Study Results

    No Results Posted as of Oct 12, 2021