ATtention Test and Executive Functions After STroke to Predict Depression.

Post-stroke Depression Clinical Trial

— ATTEST-Depress  

Official title:

Predictivity of Attention Test and Executive Functions After Stroke to Predict Depression 3 Months After Stroke.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04008719
• Other study ID #: D17-P02
• Status: Completed
• Phase: N/A
• Start date: May 16, 2017
• Est. completion date: September 30, 2019

Study information

• Verified date: July 2019
• Source: Centre Hospitalier St Anne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: September 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Post-stroke Depression
• Stroke

Intervention

Other:
• Thymic history
This interview concerns mainly the nature of the previous psychiatric and psychological care
• Evaluation of the psychiatric disorders
Mini International Neuropsychiatric Interview for the positive diagnosis of depression - under the MINI score of depression.
• 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.

Locations

Country	Name	City	State
France	Neurology service	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier St Anne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 .	3 months
Secondary	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	1 day