Post-Traumatic Stress Disorder in Old AgeI-TSPT-RNCT03897855
Memory Inhibition and Delayed Onset Post-traumatic Stress Disorder in Older Subjects
A study testing Post Traumatic Stress Disorder in people with Post-Traumatic Stress Disorder in Old Age, run by Centre Hospitalier de Niort at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Post-Traumatic Stress Disorder in Old Age
- What is being tested?
- Post Traumatic Stress Disorder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2019to 26 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- -
- 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.
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- 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).
Who cannot join
- 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:
- 22 if no diploma
- 23 if certificate of study
- 25 if patent
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- 26 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Post Traumatic Stress Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post Traumatic Stress DisorderOther
The test "Think / No-Think"
| Study group | Role | What they receive |
|---|---|---|
| Patient (TSPT-R) | Other | Post Traumatic Stress Disorder Receives: Other: Post Traumatic Stress Disorder |
| control | Experimental | No Post Traumatic Stress Disorder Receives: Other: Post Traumatic Stress Disorder |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2019
- Study start1 Apr 2019
- Primary completion15 Apr 2019
- Study completion26 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Traumatic Stress Disorder in Old AgeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Niort
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dominique LEGER, Doctor, Study director, Centre Hospitalier de Niort
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03897855
- Sponsor's protocol ID
- CH-NIORT-2018-02
- Acronym
- I-TSPT-R
- Status last verified
- Jul 2021
- First submitted
- 29 Mar 2019
- Last updated
- 30 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Memory Inhibition and Delayed Onset Post-traumatic Stress Disorder in Older Subjects
- ClinicalTrials.gov ID
- NCT03897855
- Acronym / sponsor ID
- I-TSPT-R / CH-NIORT-2018-02
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Centre Hospitalier de NiortUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 15 Apr 2019 (actual)
- Study completion
- 26 Mar 2021 (actual)
- First posted
- 1 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient (TSPT-R) | Other | Other: Post Traumatic Stress DisorderPost Traumatic Stress Disorder |
| control | Experimental | Other: Post Traumatic Stress DisorderNo Post Traumatic Stress Disorder |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (12 listed)
- -
- 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.
Key exclusion criteria (13 listed)
- 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:
- Sensory or motor disorder preventing the passing of different tests
- Psychotic disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Post Traumatic Stress DisorderThe test "Think / No-Think" | Other | Patient (TSPT-R), control |
Primary outcome
Inhibition score measured by the Think / No-Think Test
Time frame: 1 month
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dominique LEGER, Doctor study director
Centre Hospitalier de Niort
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Post Traumatic Stress Disorder in people with Post-Traumatic Stress Disorder in Old Age, run by Centre Hospitalier de Niort at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inhibition score measured by the Think / No-Think Test (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2021.