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

Ege University

Status: Completed

Conditions: Stroke Recurrence; Cardiovascular Events; Depression

Treatments: Drug: Citalopram

Study type: Interventional

Funder types: Other

Identifiers

NCT04776226

EU-2018/55

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,230 patients

Sex: All

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,230 participants in 3 patient groups

Patients without depression

No Intervention group

Description:

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

Depressive patients with treatment

Experimental group

Description:

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

Treatment:

Drug: Citalopram

Depressive patients wihout treatment

No Intervention group

Description:

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