Post-stroke Depression Treatment Effect on Stroke Recurrence | NCT04776226

Studies
Post-stroke Depression Treatment Effect on Stroke Recurrence

NCT04776226

Sponsor

Ege University

Status

Completed

Last Update Posted

Mar 1, 2021Actual

Enrollment

1,230Actual

Phase

Not Applicable

Conditions

Stroke Recurrence
Cardiovascular Events
Depression

Interventions

Citalopram

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 11, 2017Actual

Primary Completion Date

Mar 10, 2018Actual

Completion Date

Mar 30, 2019Actual

First Submitted Date

Jan 24, 2021

First Submission Date that Met QC Criteria

Feb 26, 2021

First Posted Date

Mar 1, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 26, 2021

Last Update Posted Date

Mar 1, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,230Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients without depression	No Intervention	This group included patients without depression during enrollment of the cases.
Depressive patients with treatment	Experimental	This group included patients wit depression but with treatment during enrollment of the cases.	Drug: Citalopram
Depressive patients wihout treatment	No Intervention	This group included patients without depression but withou treatment during enrollment of the cases.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Citalopram	Drug	Antidepressant use in patients with depression	Depressive patients with treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Stroke recurrence	Standard World Health Organization definitions were used for recurrent stroke	12 months

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Huseyin Nezih Özdemir, MD	Ege University Scool of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ege University		Izmir		35100	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Individual deidentified participant data are available, including data dictionaries. .Data were entered into the registry between April 2018 and December 2019.
Other documents are available (e.g., study protocol, statistical analysis plan).

Types

Study Protocol
Statistical Analysis Plan (SAP)

Time Frame

12 months

Access Criteria

The data will be shared with anyone on reasonable reason.

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003863	Depression
D020521	Stroke
D009203	Myocardial Infarction

Ancestor Terms

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior
D002561	Cerebrovascular Disorders
D001927	Brain Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015283	Citalopram

Ancestor Terms

ID	Term
D011437	Propylamines
D000588	Amines
D009930	Organic Chemicals
D009570	Nitriles
D001572

Browse Leaves

Not provided

Browse Branches

Not provided