Post-stroke Depression Treatment Effect on Stroke Recurrence

Not Applicable

Completed

• Conditions: Cardiovascular Events; Stroke Recurrence; Depression
• Interventions: Drug: Citalopram

• Registration Number: NCT04776226
• Lead Sponsor: Ege University

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.

Study Timeline

• Study Start: 2017-02-11
• Primary Completion: 2018-03-10
• Study Completion: 2019-03-30
• Study First Submitted: 2021-01-24
• Status Verified: 2021-02
• Study First Submitted QC: 2021-02-26
• Last Update Submitted: 2021-02-26
• Study First Posted: 2021-03-01
• Last Update Posted: 2021-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1230

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Depressive patients with treatment	Citalopram	This group included patients wit depression but with treatment during enrollment of the cases.

Primary Outcome Measures

Name	Time	Method
Stroke recurrence	12 months	Standard World Health Organization definitions were used for recurrent stroke

Secondary Outcome Measures

Name	Time	Method
Cardiovascular Event	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.

Trial Locations

Locations (1)

Ege University; 🇹🇷 İzmir, Turkey