NCT03897855

Brief Summary

In the elderly, we can see a post-traumatic syndrome associated with an event that occurred before old age that had not previously manifested or not fully manifested. This little-known pathology and notable psychiatric co-morbidities (depression, anxiety) can take in elderly subjects different masks that interfere with diagnosis and treatment. The data in the literature suggest that this Post-Traumatic Stress Disorder with Delayed Expression (TSPT-R) may be related to a deficiency of the executive functions of inhibition, and more particularly a deficit of mental memory inhibition and therefore the removal of unwanted memories.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 1, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2019

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 26, 2021

Completed
Last Updated

July 30, 2021

Status Verified

July 1, 2021

Enrollment Period

14 days

First QC Date

March 29, 2019

Last Update Submit

July 29, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Inhibition score measured by the Think / No-Think Test

    the average of the inhibition score measured by the "Think / No-Think" test as defined by Anderson and Green (2001) and then reviewed by Anderson et al. in 2011

    1 month

Study Arms (2)

Patient (TSPT-R)

OTHER

Post Traumatic Stress Disorder

Other: Post Traumatic Stress Disorder

control

EXPERIMENTAL

No Post Traumatic Stress Disorder

Other: Post Traumatic Stress Disorder

Interventions

The test "Think / No-Think"

Patient (TSPT-R)control

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Regarding the constitution of the group patient (TSPT-R):
  • Subjects 65 years of age or older
  • Clinical diagnosis of delayed-onset PTSD according to DSM-5 criteria after 65 years
  • The traumatic event must have taken place at the latest before 65 years
  • Affiliated person or beneficiary of a social security scheme.
  • Written consent before any examination required by research)
  • Regarding the constitution of the control group:
  • Subjects 65 years of age or older
  • No diagnosis of PTSD (delayed or not) or history of PTSD (delayed or not)
  • Affiliated person or beneficiary of a social security scheme.
  • Written consent before any examination required by the research).

You may not qualify if:

  • For both groups:
  • Acute or chronic cognitive impairment known
  • GRECO MMSE pathological score less than or equal to the pathological threshold weighted according to level of education and age, namely:
  • if no diploma
  • if certificate of study
  • if patent
  • if bin or more
  • Remove one point at each threshold if age\> 80 years
  • Sensory or motor disorder preventing the passing of different tests
  • Psychotic disorder
  • Mood disorder in decompensation (for depression, HAD-D score equal to or greater than 11)
  • Disorder of the use of a moderate or severe substance (except tobacco).
  • Patients under guardianship or curatorship.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier de Niort

Niort, 79021, France

Location

Study Officials

  • Dominique LEGER, Doctor

    Centre Hospitalier de Niort

    STUDY DIRECTOR

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

March 29, 2019

First Posted

April 1, 2019

Study Start

April 1, 2019

Primary Completion

April 15, 2019

Study Completion

March 26, 2021

Last Updated

July 30, 2021

Record last verified: 2021-07

Locations