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Post-stroke Depression Treatment Effect on Stroke Recurrence (STROKE)

Primary Purpose

Stroke Recurrence, Cardiovascular Events, Depression

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Citalopram
Sponsored by
Ege University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stroke Recurrence focused on measuring Depression, Treatment, Stroke, Myocardial infarction

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

• Patients who met DSM-IV and V criteria for depression

Exclusion Criteria:

  • Severe or unstable medical disorders (eg, myocardial infarction within past 3 months, end-stage cancer, decompensated cardiac failure)
  • Known primary neurological disorders including dementia, delirium, Parkinson disease, brain tumors, multiple sclerosis, seizure disorder
  • Drugs (eg, systemic steroids)
  • Pancreatic cancer, uncorrected hypothyroidism
  • Current suicidal risk
  • Use of psychotropic prescription or nonprescription drugs, certain hypnotics
  • Mini-Mental State Examination (MMSE) score of 21 or lower

Sites / Locations

  • Ege University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

No Intervention

Arm Label

Patients without depression

Depressive patients with treatment

Depressive patients wihout treatment

Arm Description

This group included patients without depression during enrollment of the cases.

This group included patients wit depression but with treatment during enrollment of the cases.

This group included patients without depression but withou treatment during enrollment of the cases.

Outcomes

Primary Outcome Measures

Stroke recurrence
Standard World Health Organization definitions were used for recurrent stroke

Secondary Outcome Measures

Cardiovascular Event
Cardiovascular events were defined and recorded over the study period if they had at least one of the following: myocardial infarction; unstable angina; angina; percutaneous coronary intervention; or coronary artery bypass graft surgery.

Full Information

First Posted
January 24, 2021
Last Updated
February 26, 2021
Sponsor
Ege University
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1. Study Identification

Unique Protocol Identification Number
NCT04776226
Brief Title
Post-stroke Depression Treatment Effect on Stroke Recurrence
Acronym
STROKE
Official Title
Impact of Pots-stroke Depression Treatment on Stroke Recurrence
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
February 11, 2017 (Actual)
Primary Completion Date
March 10, 2018 (Actual)
Study Completion Date
March 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ege University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
It is not clear whether depresssion can predispose, or precipitate stroke recurrence in patients with stroke. We sought the relationship of post stroke depression with stroke recurrence.
Detailed Description
A large body of evidence suggests that depression is associated with a increased risk of many chronic diseases, including hypertension, diabetes, stroke and particularly coronary heart disease. Post stroke depression (PSD) may develop as a result of vascular disease. A previous meta-analysis showed that depression significantly increased the risk of development of stroke, and this increase was probably independent of other risk factors, including hypertension and diabetes. Clarifying this issue has important implications; if depression increases the risk of development of recurrent stroke, so treating PSD might decrease the occurrence of recurrent stroke. To our knowledge there is no study attempting to clarify the relationship between PSD treatment and stroke recurrence. To fill these gap, we systematically conducted a study to assess whether PSD is associated with recurrent stroke, cardiovascular events or death. Thus, in the current study, three different arms of follow-up of patients with first-ever stroke, were used to predict the outcome over 52 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke Recurrence, Cardiovascular Events, Depression
Keywords
Depression, Treatment, Stroke, Myocardial infarction

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Three-site, prospective, nonrandomized controlled trial.
Masking
Outcomes Assessor
Masking Description
There is no masking
Allocation
Non-Randomized
Enrollment
1230 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients without depression
Arm Type
No Intervention
Arm Description
This group included patients without depression during enrollment of the cases.
Arm Title
Depressive patients with treatment
Arm Type
Experimental
Arm Description
This group included patients wit depression but with treatment during enrollment of the cases.
Arm Title
Depressive patients wihout treatment
Arm Type
No Intervention
Arm Description
This group included patients without depression but withou treatment during enrollment of the cases.
Intervention Type
Drug
Intervention Name(s)
Citalopram
Other Intervention Name(s)
Treatment group, Nontreatment group
Intervention Description
Antidepressant use in patients with depression
Primary Outcome Measure Information:
Title
Stroke recurrence
Description
Standard World Health Organization definitions were used for recurrent stroke
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Cardiovascular Event
Description
Cardiovascular events were defined and recorded over the study period if they had at least one of the following: myocardial infarction; unstable angina; angina; percutaneous coronary intervention; or coronary artery bypass graft surgery.
Time Frame
12 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: • Patients who met DSM-IV and V criteria for depression Exclusion Criteria: Severe or unstable medical disorders (eg, myocardial infarction within past 3 months, end-stage cancer, decompensated cardiac failure) Known primary neurological disorders including dementia, delirium, Parkinson disease, brain tumors, multiple sclerosis, seizure disorder Drugs (eg, systemic steroids) Pancreatic cancer, uncorrected hypothyroidism Current suicidal risk Use of psychotropic prescription or nonprescription drugs, certain hypnotics Mini-Mental State Examination (MMSE) score of 21 or lower
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huseyin Nezih Özdemir, MD
Organizational Affiliation
Ege University Scool of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ege University
City
İzmir
ZIP/Postal Code
35100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual deidentified participant data are available, including data dictionaries. .Data were entered into the registry between April 2018 and December 2019. Other documents are available (e.g., study protocol, statistical analysis plan).
IPD Sharing Time Frame
12 months
IPD Sharing Access Criteria
The data will be shared with anyone on reasonable reason.

Learn more about this trial

Post-stroke Depression Treatment Effect on Stroke Recurrence

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