NCT02889042

Brief Summary

France is one of the European countries with the highest rate of death by suicide, more than 10 400 deaths each year, about 16 people out of 100 000. Although suicide mortality rate tends to fall between 1987 and 2008 the number of suicide attempts (TS) against observed by an upward trend between 2005 and 2010. However, the most important predictor of death by suicide remains the TS. Now these are primarily TS Poisoning Drug-Volunteer (IMV), especially benzodiazepines. These IMV, there have been 16% recurrence in the past year and 21% at 4 years among hospitalized patients. Or a Health Barometer 2005 survey showed that 58% of respondents with a TS over the last 12 months had not been hospitalized. This type of acting out, especially the repeated IMV (IMVr) is underestimated epidemiologically because it is an unknown phenomenon and too little screened by health professionals.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 19, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 19, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 19, 2016

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

August 3, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 5, 2016

Completed
Last Updated

December 27, 2019

Status Verified

December 1, 2019

Enrollment Period

Same day

First QC Date

August 3, 2016

Last Update Submit

December 26, 2019

Conditions

Volunteers Repeated Drug PoisoningAlcoholicVolunteers

Outcome Measures

Primary Outcomes (1)

  • Comparison of local measurements of changes in the BOLD (Blood Oxygenation Level Dependent) based on visual stimuli by anatomical and functional MRI

    15 days of the passage to the act

Study Arms (4)

Volunteers repeated drug poisoning

EXPERIMENTAL

performing MRI and a biological assessment

Other: MRI and biological assessment

Volunteers single drug poisoning

OTHER

performing MRI and a biological assessment

Other: MRI and biological assessment

alcoholic

OTHER

performing MRI and a biological assessment

Other: MRI and biological assessment

volunteers

OTHER

performing MRI and a biological assessment

Other: MRI and biological assessment

Interventions

MRI and biological assessmentOTHER

performing a MRI and a biological assessment

Volunteers repeated drug poisoningVolunteers single drug poisoningalcoholicvolunteers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Will be offered for study subjects that meet the following criteria:
  • Man or woman hospitalized (e) in the aftermath of a IMV:
  • History of at least 2 for the IMV group IMVr
  • First suicide attempt high intentionality (SIS score\> 20/30) for group IMVS
  • Man or woman with alcohol dependence according to DSM-IV-TR, in the aftermath of withdrawal (outpatient or inpatient) for the alcohol group
  • Man or woman free from any addictive disorder, suicidal or mood for the control group
  • And all of the following criteria:
  • Age greater than or equal to 18 and less than or equal to 60 years
  • Informed consent in writing signed by the patient
  • Person affiliated to the social security or beneficiary of such a scheme

You may not qualify if:

  • For IMVS Group:
  • Have a history of scarification or addictive disorder (behavioral or product)
  • In the alcohol group:
  • TS present history
  • For all patients, presenting at least one of the following criteria:
  • Age less than 18 years, over 60 years.
  • acute or chronic delusional disorder.
  • Cognitive impairment or impeding the reading comprehension quizzes.
  • secondary pathologies at a stroke.
  • Denial of participation.
  • Contraindications to MRI.
  • Subjects with clinically significant gastrointestinal, renal, hepatic, endocrine, cardiovascular or respiratory (especially persistent asthma) which can prevent stay of 60 min in MRI without being hindered.
  • No participant to another pharmacological study.
  • unauthorized treatments: all psychotropic treatments (except anti-anxiety treatments benzodiazepine average duration of action and antihistamine), baclofen and other treatment can modify vasoreactivity fMRI.
  • Coagulation disorders against-indicating blood.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Grenoble

Grenoble, 38043, France

Location

MeSH Terms

Interventions

Magnetic Resonance Spectroscopy

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • PENNEL Lucie

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2016

First Posted

September 5, 2016

Study Start

July 19, 2016

Primary Completion

July 19, 2016

Study Completion

July 19, 2016

Last Updated

December 27, 2019

Record last verified: 2019-12

Locations

FR(1)