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NCT Number: NCT05075291

Suicide Attempts and Tramadol : a Case Report

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.

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Key information

Conditions

Suicide, Attempted Addiction Behavior Behavior, Addictive Behavioral Symptoms Compulsive Behavior Impulsive Behavior Self-Injurious Behavior Suicide

Sex eligibility

Female

Study type

Observational

Primary location

Uhmontpellier

Montpellier, 34295, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Multiple suicide attempts
  • Tramadol addiction

NA : patient case report

Exclusion criteria

  • None

Treatment and study plan

Primary outcomes

  1. Lifetime suicidal events

    Time frame: day 1

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

Secondary outcomes

  1. Depressive symptomatology

    Time frame: 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

    Time frame: 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

    Time frame: day 1

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

  4. Anxiety

    Time frame: day 1

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

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

Repeated Suicide Attempts in a Patient Suffering From Addiction to Tramadol: a Case Report

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Oct 12, 2021
Registry last updated
Oct 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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