STROKE: Post-stroke Depression Treatment Effect on Stroke Recurrence

Sponsor

Ege University (Other)

Overall Status

Completed

CT.gov ID

NCT04776226

Collaborator

(none)

1,230

Enrollment

Location

Arms

25.5

Actual Duration (Months)

48.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke Recurrence Cardiovascular Events Depression	Drug: Citalopram	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

1230 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Three-site, prospective, nonrandomized controlled trial.Three-site, prospective, nonrandomized controlled trial.

Masking:

Single (Outcomes Assessor)

Masking Description:

There is no masking

Primary Purpose:

Prevention

Official Title:

Impact of Pots-stroke Depression Treatment on Stroke Recurrence

Actual Study Start Date :

Feb 11, 2017

Actual Primary Completion Date :

Mar 10, 2018

Actual Study Completion Date :

Mar 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Patients without depression This group included patients without depression during enrollment of the cases.
Experimental: Depressive patients with treatment This group included patients wit depression but with treatment during enrollment of the cases.	Drug: Citalopram Antidepressant use in patients with depression Other Names: Treatment group Nontreatment group
No Intervention: Depressive patients wihout treatment This group included patients without depression but withou treatment during enrollment of the cases.

Arm

Intervention/Treatment

No Intervention: Patients without depression

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

Experimental: Depressive patients with treatment

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

Drug: Citalopram

Antidepressant use in patients with depression

Other Names:

Treatment group

Nontreatment group

No Intervention: Depressive patients wihout treatment

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

Outcome Measures

Primary Outcome Measures

Stroke recurrence [12 months]
Standard World Health Organization definitions were used for recurrent stroke

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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