Suicide Attempts and Tramadol : a Case Report | NCT05075291

Studies
Suicide Attempts and Tramadol : a Case Report

NCT05075291

Sponsor

University Hospital, Montpellier

Status

Completed

Last Update Posted

Oct 12, 2021Actual

Enrollment

1Actual

Phase

Not provided

Conditions

Suicide, Attempted
Addiction

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2020Actual

Primary Completion Date

Nov 1, 2020Actual

Completion Date

Jul 30, 2021Actual

First Submitted Date

Sep 18, 2021

First Submission Date that Met QC Criteria

Sep 29, 2021

First Posted Date

Oct 12, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 29, 2021

Last Update Posted Date

Oct 12, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Multiple suicide attempts
Tramadol addiction

NA : patient case report

Exclusion criteria:

- None

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

A single patient with multiple suicide attempts related to her addiction to Tramadol.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bénédicte NOBILE, PharmD, PhD	University Hospital, Montpellier	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Uhmontpellier		Montpellier		34295	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013406	Suicide, Attempted
D016739	Behavior, Addictive
D013405	Suicide

Ancestor Terms

ID	Term
D016728	Self-Injurious Behavior
D001526	Behavioral Symptoms
D001519	Behavior
D003192	Compulsive Behavior

Browse Leaves

Not provided

Browse Branches

Not provided