Suicide Attempts and Tramadol : a Case Report

Completed

• Conditions: Suicide, Attempted; Addiction

• Registration Number: NCT05075291
• Lead Sponsor: University Hospital, Montpellier

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-01
• Primary Completion: 2020-11-01
• Study Completion: 2021-07-30
• Status Verified: 2021-09
• Study First Submitted: 2021-09-18
• Study First Submitted QC: 2021-09-29
• Last Update Submitted: 2021-09-29
• Study First Posted: 2021-10-12
• Last Update Posted: 2021-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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.
Psychological pain	day 1	Psychological pain assessed with a Likert scale : Strongly disagree, Disagree, Neutral, Agree, Strongly agree
Anxiety	day 1	Anxiety level assessed with a Likert scale : Strongly disagree, Disagree, Neutral, Agree, Strongly agree

Trial Locations

Locations (1)

Uhmontpellier; 🇫🇷 Montpellier, France