Post-stroke DepressionATTEST-DepressNCT04008719
ATtention Test and Executive Functions After STroke to Predict Depression.
A study testing Thymic history, Evaluation of the psychiatric disorders and Cognitive evaluation in people with Post-stroke Depression, run by Centre Hospitalier St Anne at 1 site in France.
Trial summary
The purpose of this study is to determine whether cognitive function evaluation (sustained attention, executive functions, working memory) during acute post-stroke is predictive of a 3 months post-stroke depression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-stroke Depression
- What is being tested?
- Thymic history, Evaluation of the psychiatric disorders and Cognitive evaluation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteFrance
- Study dates
- 16 May 2017to 30 Sep 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or more
- Ischemic or hemorragic stroke, diagnosed with radiology : cerebral CT or MRI, 14 days or less after stroke
- Signed Consent
- Social insurance regime affiliation
Who cannot join
- Death
- No possibility of follow-up
- No French-speaker : insufficient command of French
- Deprivation of liberty : judicial or administrative decision
- D2 test assessment impossibility
- Aphasia with major disorder of the understanding (Boston <8)
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- Antidepressant treatment during stroke
- Depression during stroke
- protected people
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predictivity of Attention Test and Executive Functions After Stroke to Predict Depression 3 Months After Stroke.
The purpose of this study is to determine whether cognitive function evaluation (sustained attention, executive functions, working memory) during acute post-stroke is predictive of a 3 months post-stroke depression.
Read the detailed description
- Baseline visit: after neurologic stability, 14 days or less after stroke and before discharge.
- First assessment :
- Neurologic data: morphologic data (MRI of the brain), stroke severity (NIHSScore), aphasia assessment (Boston Diagnostic Aphasia Examination) if NIHS verbal score ≥1, hemineglect assessment (Bells test).
- Personal data assessment :
- Socio demographic : age, gender, marital status, employment, level of education ii. Medical history: medical treatments, psychiatric and non psychiatric history.
- Psychiatric assessment i. Mini International Neuropsychiatric Interview - depression ii. Beck Depression Inventory iii. Clinical Global Impression iv. Standardized Assessment of Personality - Abbreviated Scale (SAPAS) v. Fageström-C vi. Alcohol Use Disorders Identification Test (AUDIT-C) d. Cognitive assessment: i. Verbal memory : Dubois's five words ii. Clock drawing test iii. D2test (computerized) iv. Verbal fluency (Cardebat) v. Working memory (digit span WAIS 3) vi. Brixton (computerized)
- Assessment 3 months after the first assessment. Phone call and psychiatric assessment: MINI depression, Beck Depression Inventory. Barthel index and Quality of Life assessment.
- Conditions
- Post-stroke Depression
- Being tested
- Thymic history, Evaluation of the psychiatric disorders, Cognitive evaluation
- Keywords
- Depression
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thymic historyOther
This interview concerns mainly the nature of the previous psychiatric and psychological care
Evaluation of the psychiatric disordersOther
Mini International Neuropsychiatric Interview for the positive diagnosis of depression - under the MINI score of depression.
Cognitive evaluationOther
They will be held consecutively to the patient's bedside interview on the same day. Some tests will be computerized, others will be in paper form.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Other | Assessments are made by a psychiatrist Receives: Other: Thymic history; Other: Evaluation of the psychiatric disorders; Other: Cognitive evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post stroke depression
Whether or not a post-stroke depression occurs. occurrence of post-stroke depression assessed with Mini International Neuropsychiatric Interview (MINI), subscale depression .
Measured: 3 months
Secondary outcomes (1)
Post-stroke depression population characterization
Age, gender, marital status, occupation, level of education, laterality of stroke,and medical and psychiatric history will be collected during the inclusion interview and cognitive tests
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start16 May 2017
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-stroke DepressionStudies 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier St Anne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philip GORWOOD, MD, PhD, Study director, CHSA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04008719
- Sponsor's protocol ID
- D17-P02
- Acronym
- ATTEST-Depress
- Status last verified
- Jul 2019
- First submitted
- 27 Apr 2017
- Last updated
- 28 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictivity of Attention Test and Executive Functions After Stroke to Predict Depression 3 Months After Stroke.
- ClinicalTrials.gov ID
- NCT04008719
- Acronym / sponsor ID
- ATTEST-Depress / D17-P02
- Conditions
- Post-stroke Depression
- Keywords
- Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Centre Hospitalier St AnneUniversity, hospital or other
- Study start
- 16 May 2017 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 5 Jul 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.
The purpose of this study is to determine whether cognitive function evaluation (sustained attention, executive functions, working memory) during acute post-stroke is predictive of a 3 months post-stroke depression.
Detailed description
- Baseline visit: after neurologic stability, 14 days or less after stroke and before discharge.
- First assessment :
- Neurologic data: morphologic data (MRI of the brain), stroke severity (NIHSScore), aphasia assessment (Boston Diagnostic Aphasia Examination) if NIHS verbal score ≥1, hemineglect assessment (Bells test).
- Personal data assessment :
- Socio demographic : age, gender, marital status, employment, level of education ii. Medical history: medical treatments, psychiatric and non psychiatric history.
- Psychiatric assessment i. Mini International Neuropsychiatric Interview - depression ii. Beck Depression Inventory iii. Clinical Global Impression iv. Standardized Assessment of Personality - Abbreviated Scale (SAPAS) v. Fageström-C vi. Alcohol Use Disorders Identification Test (AUDIT-C) d. Cognitive assessment: i. Verbal memory : Dubois's five words ii. Clock drawing test iii. D2test (computerized) iv. Verbal fluency (Cardebat) v. Working memory (digit span WAIS 3) vi. Brixton (computerized)
- Assessment 3 months after the first assessment. Phone call and psychiatric assessment: MINI depression, Beck Depression Inventory. Barthel index and Quality of Life assessment.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | Other | Other: Thymic history, Other: Evaluation of the psychiatric disorders, Other: Cognitive evaluationAssessments are made by a psychiatrist |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 or more
- Ischemic or hemorragic stroke, diagnosed with radiology : cerebral CT or MRI, 14 days or less after stroke
- Signed Consent
- Social insurance regime affiliation
Key exclusion criteria (9 listed)
- Death
- No possibility of follow-up
- No French-speaker : insufficient command of French
- Deprivation of liberty : judicial or administrative decision
- D2 test assessment impossibility
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 |
|---|---|---|
| Thymic historyThis interview concerns mainly the nature of the previous psychiatric and psychological care | Other | Patients |
| Evaluation of the psychiatric disordersMini International Neuropsychiatric Interview for the positive diagnosis of depression - under the MINI score of depression. | Other | Patients |
| Cognitive evaluationThey will be held consecutively to the patient's bedside interview on the same day. Some tests will be computerized, others will be in paper form. | Other | Patients |
Primary outcome
Post stroke depression
Time frame: 3 months
Whether or not a post-stroke depression occurs. occurrence of post-stroke depression assessed with Mini International Neuropsychiatric Interview (MINI), subscale depression .
1 secondary outcome
Post-stroke depression population characterization
Time frame: 1 day
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 28 May 2021.
- Individual participant dataSharing planned: Undecided
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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.
Philip GORWOOD, MD, PhD study director
CHSA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thymic history, Evaluation of the psychiatric disorders and Cognitive evaluation in people with Post-stroke Depression, run by Centre Hospitalier St Anne 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 4 inclusion and 9 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 28 May 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?
Post stroke depression (time frame: 3 months). 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 28 May 2021.