- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04776226
Post-stroke Depression Treatment Effect on Stroke Recurrence (STROKE)
Impact of Pots-stroke Depression Treatment on Stroke Recurrence
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
İzmir, Turkey, 35100
- Ege University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Patients without depression
This group included patients without depression during enrollment of the cases.
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Experimental: Depressive patients with treatment
This group included patients wit depression but with treatment during enrollment of the cases.
|
Antidepressant use in patients with depression
Other Names:
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No Intervention: Depressive patients wihout treatment
This group included patients without depression but withou treatment during enrollment of the cases.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stroke recurrence
Time Frame: 12 months
|
Standard World Health Organization definitions were used for recurrent stroke
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12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Huseyin Nezih Özdemir, MD, Ege University Scool of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Mood Disorders
- Disease Attributes
- Stroke
- Depression
- Depressive Disorder
- Recurrence
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Antidepressive Agents, Second-Generation
- Citalopram
Other Study ID Numbers
- EU-2018/55
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD 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).
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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