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出境医 / 临床实验 / ATtention Test and Executive Functions After STroke to Predict Depression. (ATTEST-Depress)

ATtention Test and Executive Functions After STroke to Predict Depression. (ATTEST-Depress)

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.

Condition or disease Intervention/treatment Phase
Post-stroke Depression Other: Thymic history Other: Evaluation of the psychiatric disorders Other: Cognitive evaluation Not Applicable

Detailed Description:
  1. Baseline visit: after neurologic stability, 14 days or less after stroke and before discharge.

  2. First assessment :

    1. 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).
    2. 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)

  3. 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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Predictivity of Attention Test and Executive Functions After Stroke to Predict Depression 3 Months After Stroke.
Actual Study Start Date : May 16, 2017
Actual Primary Completion Date : September 30, 2019
Actual Study Completion Date : September 30, 2019
Arms and Interventions
Arm Intervention/treatment
Patients
Assessments are made by a psychiatrist
 Other: Thymic history
This interview concerns mainly the nature of the previous psychiatric and psychological care

Other: Evaluation of the psychiatric disorders
Mini International Neuropsychiatric Interview for the positive diagnosis of depression - under the MINI score of depression.

Other: Cognitive evaluation
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.
Outcome Measures
Primary Outcome Measures :
  1. 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 .


Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Locations
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France
Neurology service
Paris, France, 75014
Sponsors and Collaborators
Centre Hospitalier St Anne
Investigators
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Study Director: Philip GORWOOD, MD, PhD CHSA
Tracking Information
First Submitted Date  ICMJE April 27, 2017
First Posted Date  ICMJE July 5, 2019
Last Update Posted Date May 28, 2021
Actual Study Start Date  ICMJE May 16, 2017
Actual Primary Completion Date September 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 4, 2019) 		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 .
Original Primary Outcome Measures  ICMJE
 (submitted: July 3, 2019) 		Post stroke depression [ Time Frame: 3 months ]
Whether or not a post-stroke depression occurs
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 3, 2019) 		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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ATtention Test and Executive Functions After STroke to Predict Depression.
Official Title  ICMJE Predictivity of Attention Test and Executive Functions After Stroke to Predict Depression 3 Months After Stroke.
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
  1. Baseline visit: after neurologic stability, 14 days or less after stroke and before discharge.

  2. First assessment :

    1. 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).
    2. 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)

  3. 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE Post-stroke Depression
Intervention  ICMJE
  • Other: Thymic history
    This interview concerns mainly the nature of the previous psychiatric and psychological care
  • Other: Evaluation of the psychiatric disorders
    Mini International Neuropsychiatric Interview for the positive diagnosis of depression - under the MINI score of depression.
  • Other: Cognitive evaluation
    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 Arms  ICMJE Patients
Assessments are made by a psychiatrist
Interventions:
  • Other: Thymic history
  • Other: Evaluation of the psychiatric disorders
  • Other: Cognitive evaluation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 27, 2021) 		74
Original Actual Enrollment  ICMJE
 (submitted: July 3, 2019) 		69
Actual Study Completion Date  ICMJE September 30, 2019
Actual Primary Completion Date September 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04008719
Other Study ID Numbers  ICMJE D17-P02
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Centre Hospitalier St Anne
Study Sponsor  ICMJE Centre Hospitalier St Anne
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Philip GORWOOD, MD, PhD CHSA
PRS Account Centre Hospitalier St Anne
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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