Post-stroke Depression Treatment Effect on Stroke Recurrence

NCT04776226 | Completed DMC

• 1 other identifier: EU-2018/55
• Study Type: interventional
• Target: 1,230
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke Recurrence; Cardiovascular Events; Depression

Keywords

Depression; Treatment; Stroke; Myocardial infarction

Outcome Measures

Primary Outcomes (1)

• Stroke recurrence

  Standard World Health Organization definitions were used for recurrent stroke

  12 months

Secondary Outcomes (1)

• Cardiovascular Event

  12 months

Study Arms (3)

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

Citalopram DRUG

Antidepressant use in patients with depression

Also known as: Treatment group, Nontreatment group

Depressive patients with treatment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who met DSM-IV and V criteria for depression

You may not qualify if:

• 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

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege University

Izmir, 35100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Depression; Stroke; Myocardial Infarction

Interventions

Citalopram

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Myocardial Ischemia; Heart Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Huseyin Nezih Özdemir, MD

  Ege University Scool of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: There is no masking
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. MD

Model Details: Three-site, prospective, nonrandomized controlled trial.

Study Record Dates

• First Submitted: January 24, 2021
• First Posted: March 1, 2021
• Study Start: February 11, 2017
• Primary Completion: March 10, 2018
• Study Completion: March 30, 2019
• Last Updated: March 1, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 12 months
• Access Criteria: The data will be shared with anyone on reasonable reason.

Locations

TU (1)