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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00641498
Other study ID # 0601401
Secondary ID PHRC suicide
Status Completed
Phase N/A
First received March 17, 2008
Last updated March 27, 2015
Start date March 2007
Est. completion date October 2011

Study information

Verified date March 2015
Source University Hospital, Toulouse
Contact n/a
Is FDA regulated No
Health authority France: Direction Générale de la Santé
Study type Interventional

Clinical Trial Summary

Very few studies have proved the effectiveness of treatment for suicide attempt patients. Our objective is to evaluate the addition of the resources of an suicide prevention centre to standard psychiatric treatment in the Emergency Department. Consecutive suicide attempt patients in 2 Emergency departments (multicenter study) were included after standard psychiatric treatment and referral. After Written informed consent, psychological assessment (depression, suicide intention) was carried out After randomisation, control patients were given an information card describing the Suicide Prevention Center (SPC); experimental patients had a first meeting with a psychologist of the SPC.

To verify the hypothesis of a decrease in suicidal behaviors in the experimental group, an evaluation of these behaviors was carried out every month during a two year follow-up.


Description:

Very few studies have proved the effectiveness of treatment for suicide attempt patients. Our objective is to evaluate the addition of the resources of an existent suicide prevention centre to standard psychiatric treatment in the Emergency Department. Consecutive suicide attempt (self poisoning) patients in 2 Emergency departments (multicenter study) were included after standard psychiatric treatment and referral. After Written informed consent, psychological assessment (depression, suicide intent scale/SIS Beck Depression Inventory, Toronto Ale, Beck Hopelessness Sc, Audit, mini, PDQ 4) was carried out After randomisation, control patients were given an information card describing the Suicide Prevention Center (SPC); experimental patients had a first meeting with a psychologist of the SPC. The number of subjects included should be 405 per group. To verify the hypothesis of a decrease in suicidal behaviors in the experimental group, an evaluation of these behaviors was carried out every month during a two year follow-up The frequency of subsequent suicidal behavior will be monitored by the scrutiny of the Emergency Dept records. Death by suicide will be identified by the examination of information obtained from the national death statistics office (INSERM).


Recruitment information / eligibility

Status Completed
Enrollment 607
Est. completion date October 2011
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- parasuicide by self-poisoning

- Glasgow score=15

- Standard psychiatric treatment

Exclusion Criteria:

- No speaking french

- committed inpatient

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Behavioral:
Psychotherapy
Individual supportive

Locations

Country Name City State
France Service d'Accueil des Urgences Brive-la Gaillarde
France Laboratoire de Stress Post-Traumatique Toulouse

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Suicide behavior defined by self poisoning or other suicidal attempts in the emergency departments of the region. Death by suicide will be identified by the examination of information obtained from the national death statistics office (INSERM). 2 years Yes
Secondary Level of depression, suicide ideation, level of despair, level of alexithymia 2 years Yes