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

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

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.

Study Overview

• Status: Completed
• Conditions: Post-stroke Depression
• Intervention / Treatment: Other: Thymic history; Other: Evaluation of the psychiatric disorders; Other: Cognitive evaluation

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: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75014
    • Neurology service

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier St Anne
• Investigators: Study Director: Philip GORWOOD, MD, PhD, CHSA

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2017
• Primary Completion (Actual): September 30, 2019
• Study Completion (Actual): September 30, 2019

Study Registration Dates

• First Submitted: April 27, 2017
• First Submitted That Met QC Criteria: July 3, 2019
• First Posted (Actual): July 5, 2019

Study Record Updates

• Last Update Posted (Actual): May 28, 2021
• Last Update Submitted That Met QC Criteria: May 27, 2021
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Depression
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mood Disorders; Stroke; Depression; Depressive Disorder
• Other Study ID Numbers: D17-P02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No