ATtention Test and Executive Functions After STroke to Predict Depression. (ATTEST-Depress)
Primary Purpose
Post-stroke Depression
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Thymic history
Evaluation of the psychiatric disorders
Cognitive evaluation
Sponsored by
About this trial
This is an interventional screening trial for Post-stroke Depression focused on measuring Depression
Eligibility Criteria
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
Sites / Locations
- Neurology service
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Patients
Arm Description
Assessments are made by a psychiatrist
Outcomes
Primary Outcome Measures
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 .
Secondary Outcome Measures
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
Full Information
NCT ID
NCT04008719
First Posted
April 27, 2017
Last Updated
May 27, 2021
Sponsor
Centre Hospitalier St Anne
1. Study Identification
Unique Protocol Identification Number
NCT04008719
Brief Title
ATtention Test and Executive Functions After STroke to Predict Depression.
Acronym
ATTEST-Depress
Official Title
Predictivity of Attention Test and Executive Functions After Stroke to Predict Depression 3 Months After Stroke.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
May 16, 2017 (Actual)
Primary Completion Date
September 30, 2019 (Actual)
Study Completion Date
September 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier St Anne
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-stroke Depression
Keywords
Depression
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients
Arm Type
Other
Arm Description
Assessments are made by a psychiatrist
Intervention Type
Other
Intervention Name(s)
Thymic history
Intervention Description
This interview concerns mainly the nature of the previous psychiatric and psychological care
Intervention Type
Other
Intervention Name(s)
Evaluation of the psychiatric disorders
Intervention Description
Mini International Neuropsychiatric Interview for the positive diagnosis of depression - under the MINI score of depression.
Intervention Type
Other
Intervention Name(s)
Cognitive evaluation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Post stroke depression
Description
Whether or not a post-stroke depression occurs. occurrence of post-stroke depression assessed with Mini International Neuropsychiatric Interview (MINI), subscale depression .
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Post-stroke depression population characterization
Description
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
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip GORWOOD, MD, PhD
Organizational Affiliation
CHSA
Official's Role
Study Director
Facility Information:
Facility Name
Neurology service
City
Paris
ZIP/Postal Code
75014
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
ATtention Test and Executive Functions After STroke to Predict Depression.
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