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

Sponsor

Centre Hospitalier St Anne (Other)

Overall Status

Completed

CT.gov ID

NCT04008719

Collaborator

(none)

Enrollment

Location

Arm

28.5

Actual Duration (Months)

2.6

Patients Per Site Per Month

Study Details

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	N/A

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 :

Socio demographic : age, gender, marital status, employment, level of education ii. Medical history: medical treatments, psychiatric and non psychiatric history.
Psychiatric assessment i. Mini International Neuropsychiatric Interview - depression

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.

Study Design

Study Type:

Interventional

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 :

Sep 30, 2019

Actual Study Completion Date :

Sep 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Other: 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.

Arm

Intervention/Treatment

Other: 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

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

	Site	City	State	Country	Postal Code
1	Neurology service	Paris		France	75014

Sponsors and Collaborators

Centre Hospitalier St Anne

Investigators

Study Director: Philip GORWOOD, MD, PhD, CHSA

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier St Anne

ClinicalTrials.gov Identifier:

NCT04008719

Other Study ID Numbers:

D17-P02

First Posted:

Jul 5, 2019

Last Update Posted:

May 28, 2021

Last Verified:

Jul 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Centre Hospitalier St Anne

Depression

Additional relevant MeSH terms:

Stroke

Depression

Depressive Disorder

Study Results

No Results Posted as of May 28, 2021