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

February 26, 2021 updated by: Prof. Dr. Emre Kumral, Ege University

Impact of Pots-stroke Depression Treatment on Stroke Recurrence

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.

Study Overview

Status

Completed

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1230

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • İzmir, Turkey, 35100
        • Ege University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Patients without depression
This group included patients without depression during enrollment of the cases.
Experimental: Depressive patients with treatment
This group included patients wit depression but with treatment during enrollment of the cases.
Antidepressant use in patients with depression
Other Names:
  • Treatment group
  • Nontreatment group
No Intervention: Depressive patients wihout treatment
This group included patients without depression but withou treatment during enrollment of the cases.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stroke recurrence
Time Frame: 12 months
Standard World Health Organization definitions were used for recurrent stroke
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovascular Event
Time Frame: 12 months
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Huseyin Nezih Özdemir, MD, Ege University Scool of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 11, 2017

Primary Completion (Actual)

March 10, 2018

Study Completion (Actual)

March 30, 2019

Study Registration Dates

First Submitted

January 24, 2021

First Submitted That Met QC Criteria

February 26, 2021

First Posted (Actual)

March 1, 2021

Study Record Updates

Last Update Posted (Actual)

March 1, 2021

Last Update Submitted That Met QC Criteria

February 26, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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