ATtention Test and Executive Functions After STroke to Predict Depression.

Not Applicable

Completed

• Conditions: Post-stroke Depression
• Interventions: Other: Thymic history; Other: Evaluation of the psychiatric disorders; Other: Cognitive evaluation

• Registration Number: NCT04008719
• Lead Sponsor: Centre Hospitalier St Anne

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 Timeline

• Study First Submitted: 2017-04-27
• Study Start: 2017-05-16
• Status Verified: 2019-07
• Study First Submitted QC: 2019-07-03
• Study First Posted: 2019-07-05
• Primary Completion: 2019-09-30
• Study Completion: 2019-09-30
• Last Update Submitted: 2021-05-27
• Last Update Posted: 2021-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients	Cognitive evaluation	Assessments are made by a psychiatrist
Patients	Thymic history	Assessments are made by a psychiatrist
Patients	Evaluation of the psychiatric disorders	Assessments are made by a psychiatrist

Primary Outcome Measures

Name	Time	Method
Post stroke depression	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

Name	Time	Method
Post-stroke depression population characterization	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

Trial Locations

Locations (1)

Neurology service; 🇫🇷 Paris, France