ATtention Test and Executive Functions After STroke to Predict Depression.

NCT ID: NCT04008719

Last Updated: 2021-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-16

Study Completion Date

2019-09-30

Brief Summary

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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

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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.

Conditions

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Post-stroke Depression

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Patients

Assessments are made by a psychiatrist

Group Type OTHER

Thymic history

Intervention Type OTHER

This interview concerns mainly the nature of the previous psychiatric and psychological care

Evaluation of the psychiatric disorders

Intervention Type OTHER

Mini International Neuropsychiatric Interview for the positive diagnosis of depression - under the MINI score of depression.

Cognitive evaluation

Intervention Type OTHER

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.

Interventions

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Thymic history

This interview concerns mainly the nature of the previous psychiatric and psychological care

Intervention Type OTHER

Evaluation of the psychiatric disorders

Mini International Neuropsychiatric Interview for the positive diagnosis of depression - under the MINI score of depression.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier St Anne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Philip GORWOOD, MD, PhD

Role: STUDY_DIRECTOR

CHSA

Locations

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Neurology service

Paris, , France

Site Status

Countries

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France

Other Identifiers

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D17-P02

Identifier Type: -

Identifier Source: org_study_id

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