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Completed

NCT Number: NCT04776226

Post-stroke Depression Treatment Effect 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Citalopram

Drug

Antidepressant use in patients with depression

Other names: Treatment group, Nontreatment group

Primary outcomes

  1. Stroke recurrence

    Time frame: 12 months

    Standard World Health Organization definitions were used for recurrent stroke

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Ege University

Other

Registry information

Official study title

Impact of Pots-stroke Depression Treatment on Stroke Recurrence

Acronym: STROKE

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Mar 1, 2021
Registry last updated
Mar 1, 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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