ATtention Test and Executive Functions After STroke to Predict Depression. (ATTEST-Depress)
May 27, 2021 updated by: Centre Hospitalier St Anne
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 :
i. Socio demographic : age, gender, marital status, employment, level of education ii. Medical history: medical treatments, psychiatric and non psychiatric history.
c. 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 Type
Interventional
Enrollment (Actual)
74
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Paris, France, 75014
- Neurology service
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
- Antidepressant treatment during stroke
- Depression during stroke
- protected people
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Patients
Assessments are made by a psychiatrist
|
This interview concerns mainly the nature of the previous psychiatric and psychological care
Mini International Neuropsychiatric Interview for the positive diagnosis of depression - under the MINI score of depression.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 .
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Post-stroke depression population characterization
Time Frame: 1 day
|
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
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Philip GORWOOD, MD, PhD, CHSA
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 16, 2017
Primary Completion (Actual)
September 30, 2019
Study Completion (Actual)
September 30, 2019
Study Registration Dates
First Submitted
April 27, 2017
First Submitted That Met QC Criteria
July 3, 2019
First Posted (Actual)
July 5, 2019
Study Record Updates
Last Update Posted (Actual)
May 28, 2021
Last Update Submitted That Met QC Criteria
May 27, 2021
Last Verified
July 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- D17-P02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.