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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04776226
Other study ID # EU-2018/55
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 11, 2017
Est. completion date March 30, 2019

Study information

Verified date February 2021
Source Ege University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1230
Est. completion date March 30, 2019
Est. primary completion date March 10, 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Intervention

Drug:
Citalopram
Antidepressant use in patients with depression

Locations

Country Name City State
Turkey Ege University Izmir

Sponsors (1)

Lead Sponsor Collaborator
Ege University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Stroke recurrence Standard World Health Organization definitions were used for recurrent stroke 12 months
Secondary 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. 12 months
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