Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Post-stroke Depression Treatment Effect on Stroke Recurrence (STROKE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04776226
Recruitment Status : Completed
First Posted : March 1, 2021
Last Update Posted : March 1, 2021
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Emre Kumral, Ege University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 Not Applicable

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1230 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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 : February 11, 2017
Actual Primary Completion Date : March 10, 2018
Actual Study Completion Date : March 30, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Citalopram

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Stroke recurrence [ Time Frame: 12 months ]
    Standard World Health Organization definitions were used for recurrent stroke


Secondary Outcome Measures :
  1. Cardiovascular Event [ Time Frame: 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04776226


Locations
Layout table for location information
Turkey
Ege University
İzmir, Turkey, 35100
Sponsors and Collaborators
Ege University
Investigators
Layout table for investigator information
Principal Investigator: Huseyin Nezih Özdemir, MD Ege University Scool of Medicine
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Prof. Dr. Emre Kumral, Prof. Dr. MD, Ege University
ClinicalTrials.gov Identifier: NCT04776226    
Other Study ID Numbers: EU-2018/55
First Posted: March 1, 2021    Key Record Dates
Last Update Posted: March 1, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan 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).
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: 12 months
Access Criteria: The data will be shared with anyone on reasonable reason.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Prof. Dr. Emre Kumral, Ege University:
Depression
Treatment
Stroke
Myocardial infarction
Additional relevant MeSH terms:
Layout table for MeSH terms
Stroke
Recurrence
Depression
Depressive Disorder
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Behavioral Symptoms
Mood Disorders
Mental Disorders
 Disease Attributes
Pathologic Processes
Citalopram
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs