NCT04008719

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2017

Completed
19 days until next milestone

Study Start

First participant enrolled

May 16, 2017

Completed
2.1 years until next milestone

First Posted

Study publicly available on registry

July 5, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

May 28, 2021

Status Verified

July 1, 2019

Enrollment Period

2.4 years

First QC Date

April 27, 2017

Last Update Submit

May 27, 2021

Conditions

Post-stroke Depression

Keywords

Depression

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Post-stroke depression population characterization

    1 day

Study Arms (1)

Patients

OTHER

Assessments are made by a psychiatrist

Other: Thymic historyOther: Evaluation of the psychiatric disordersOther: Cognitive evaluation

Interventions

Thymic historyOTHER

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

Patients
Evaluation of the psychiatric disordersOTHER

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

Patients
Cognitive evaluationOTHER

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.

Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neurology service

Paris, 75014, France

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Philip GORWOOD, MD, PhD

    CHSA

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2017

First Posted

July 5, 2019

Study Start

May 16, 2017

Primary Completion

September 30, 2019

Study Completion

September 30, 2019

Last Updated

May 28, 2021

Record last verified: 2019-07

Locations

FR(1)