Post-stroke Depression Treatment Effect on Stroke Recurrence

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1230 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-11

Study Completion Date

2019-03-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Stroke Recurrence Cardiovascular Events Depression

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Three-site, prospective, nonrandomized controlled trial.

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

There is no masking

Study Groups

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Patients without depression

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Depressive patients with treatment

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

Group Type EXPERIMENTAL

Citalopram

Intervention Type DRUG

Antidepressant use in patients with depression

Depressive patients wihout treatment

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Citalopram

Antidepressant use in patients with depression

Intervention Type DRUG

Other Intervention Names

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Treatment group Nontreatment group

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No