Suicide Attempts and Tramadol : a Case Report

Suicide, Attempted Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05075291
• Other study ID #: RECHMPL21_0571
• Status: Completed
• Start date: November 1, 2020
• Est. completion date: July 30, 2021

Study information

• Verified date: September 2021
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: July 30, 2021
• Est. primary completion date: November 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion criteria:

• Multiple suicide attempts

• Tramadol addiction

NA : patient case report

Exclusion criteria:

• None

Related Conditions & MeSH terms

• Addiction
• Behavior, Addictive
• Suicide
• Suicide, Attempted

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lifetime suicidal events	Occurrence of suicidal events (actuel, interrupted and aborted or self-aborted suicide attempts) based on the patient medical records.	day 1
Secondary	Depressive symptomatology	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	day 1
Secondary	Suicidal ideation	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.	day 1
Secondary	Psychological pain	Psychological pain assessed with a Likert scale : Strongly disagree, Disagree, Neutral, Agree, Strongly agree	day 1
Secondary	Anxiety	Anxiety level assessed with a Likert scale : Strongly disagree, Disagree, Neutral, Agree, Strongly agree	day 1