Stroke RecurrenceSTROKENCT04776226
Post-stroke Depression Treatment Effect on Stroke Recurrence
A study testing Citalopram in people with Stroke Recurrence and Cardiovascular Events, run by Ege University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke Recurrence, Cardiovascular Events, Depression
- What is being tested?
- Citalopram
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,230 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Feb 2017to 30 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients who met DSM-IV and V criteria for depression
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Pots-stroke Depression Treatment on Stroke Recurrence
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.
Read the 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.
- Conditions
- Stroke Recurrence, Cardiovascular Events, Depression
- Being tested
- Citalopram
- Keywords
- Depression, Treatment, Stroke, Myocardial infarction
- Medical subject headings
- Depression, Stroke, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CitalopramDrug
Also called Treatment group, Nontreatment group
Antidepressant use in patients with depression
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Citalopram |
| Depressive patients wihout treatment | No intervention | This group included patients without depression but withou treatment during enrollment of the cases. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroke recurrence
Standard World Health Organization definitions were used for recurrent stroke
Measured: 12 months
Secondary outcomes (1)
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start11 Feb 2017
- Primary completion10 Mar 2018
- Study completion30 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke RecurrenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Three-site, prospective, nonrandomized controlled trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Emre Kumral, Ege University
- Investigators
- Huseyin Nezih Özdemir, MD, Principal investigator, Ege University Scool of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04776226
- Sponsor's protocol ID
- EU-2018/55
- Acronym
- STROKE
- Status last verified
- Feb 2021
- First submitted
- 24 Jan 2021
- Last updated
- 1 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: * 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).
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Pots-stroke Depression Treatment on Stroke Recurrence
- ClinicalTrials.gov ID
- NCT04776226
- Acronym / sponsor ID
- STROKE / EU-2018/55
- Conditions
- Stroke Recurrence, Cardiovascular Events, Depression
- Keywords
- Depression, Treatment, Stroke, Myocardial infarction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,230 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 11 Feb 2017 (actual)
- Primary completion
- 10 Mar 2018 (actual)
- Study completion
- 30 Mar 2019 (actual)
- First posted
- 1 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Three-site, prospective, nonrandomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Patients without depression | No intervention | –This group included patients without depression during enrollment of the cases. |
| Depressive patients with treatment | Experimental | Drug: CitalopramThis group included patients wit depression but with treatment during enrollment of the cases. |
| Depressive patients wihout treatment | No intervention | –This group included patients without depression but withou treatment during enrollment of the cases. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who met DSM-IV and V criteria for depression
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CitalopramAlso: Treatment group, Nontreatment groupAntidepressant use in patients with depression | Drug | Depressive patients with treatment |
Primary outcome
Stroke recurrence
Time frame: 12 months
Standard World Health Organization definitions were used for recurrent stroke
1 secondary outcome
Cardiovascular Event
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2021.
- Individual participant dataSharing planned: Yes. * 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).
Related trials for Stroke Recurrence
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huseyin Nezih Özdemir, MD principal investigator
Ege University Scool of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Citalopram in people with Stroke Recurrence and Cardiovascular Events, run by Ege University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stroke recurrence (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2021.