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Completed

NCT Number: NCT04008719

ATtention Test and Executive Functions After STroke to Predict Depression.

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Neurology service

Paris, 75014, France

About this study

  • 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 :

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)

  • Assessment 3 months after the first assessment. Phone call and psychiatric assessment: MINI depression, Beck Depression Inventory. Barthel index and Quality of Life assessment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Thymic history

Other

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

Evaluation of the psychiatric disorders

Other

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

Cognitive evaluation

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.

Primary outcomes

  1. Post stroke depression

    Time frame: 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 outcomes

  1. Post-stroke depression population characterization

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier St Anne

Other

Registry information

Official study title

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

Acronym: ATTEST-Depress

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jul 5, 2019
Registry last updated
May 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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