Post-stroke Depression Treatment Effect on Stroke Recurrence

Depression Clinical Trial

— STROKE  

Official title:

Impact of Pots-stroke Depression Treatment on Stroke Recurrence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04776226
• Other study ID #: EU-2018/55
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Cardiovascular Events
• Depression
• Depressive Disorder
• Recurrence
• Stroke
• Stroke Recurrence

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