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ISRCTN
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ISRCTN62169508
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ClinicalTrials.gov identifier
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Public title
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A prospective cohort study on incidence and outcome of patients with post-stroke depression in China
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Scientific title
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Acronym
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PRIOD- China
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Serial number at source
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N/A
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Study hypothesis
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1. Incidence of Post-Stroke Depression (PSD) in China may be different between 3 months and 6 months following onset of stroke
2. Patients with PSD may have poorer outcome than patients without PSD
3. Incidence of PSD may be correlated with stroke subtype, lesion location and other risk factors
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Lay summary
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Ethics approval
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Tiantan Hospital Ethics Committee. Date of approval: 12/05/2008
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Study design
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Multi-centre, observational, prospective, nested case-control study.
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Countries of recruitment
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China
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Disease/condition/study domain
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Post-stroke depression
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Participants - inclusion criteria
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1. New stoke onset
2. Stoke onset time: Within 14d from doctor-visiting date
3. Patients age 18 years or older
4. Sign informed consent, cooperate with examination, and complete follow-ups
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Participants - exclusion criteria
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1. Unable to complete examination due to the influence of eyesight, hearing, expression, consciousness, and apprehension
2. Stroke patient presenting no sign or symptom
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Anticipated start date
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10/01/2008
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Anticipated end date
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01/06/2009
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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2,500
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Interventions
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1. The participants are classified into the following groups:
Group A: Stroke inpatients with PSD during follow up at 3 months or 6 months
Group B: Stroke inpatients without PSD during follow up at 3 months or 6 months
2. Diagnostic process & criteria:
2.1. Assessment through scales:
2.1.1. Hamilton Rating Scale for Depression (HRSD). HRSD is used as preliminary screening scale. Trained qualified neurological doctors make standard depression diagnosis of all doctor-visitors with >=8 HRSD scores. Timepoints of assessment: Baseline at 14 days, 3, 6 and 12 months following onset
2.1.2. World Health Organization-Composite International Diagnostic Interview (WHO-CIDI). Trained qualified neurological doctors make standard depression diagnosis of all doctor-visitors with >=8 HRSD scores through CIDI at 3 and 6 months.
2.2. Patient self-assessment scale. Patients assess their mental state through BDI-13 scale biweekly for 3 months and monthly during 3 months - 1 year. Assessment results are recorded in follow-up diary. In case of BDI>=5 during this period, patients should visit hospital for follow-up and CIDI diagnosis by trained qualified neurological doctors.
3. Possible risk factors will be compared between group A and group B, these will include:
3.1. Stroke subtype
3.2. National Institutes of Health Stroke Scale (NIHSS) at 12 months
3.3. Medical history
3.4. Complications
3.5. Lesion location
4. Outcome will be compared between group A and group B, these will include:
4.1 Modified Rankin Scale (mRS) at 3, 6 and 12 months
4.2 Quality of life: Medical Outcome Study Short Form 36 (SF-36) at 12 months
4.3 Stroke recurrence at 3, 6 and 12 months
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Primary outcome measure(s)
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1. Onset: Incidence of depression within 3 months and 6 months of stoke onset
2. Scale score: Score tendency based on HRSD scale within 14 days, 3 months, 6 months, and 1 year of stoke onset
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Secondary outcome measure(s)
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1. Quality of life: Medical Outcome Study Short Form 36 (SF-36)
2. mRS score
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Sources of funding
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1. Wyeth pharmaceuticals
2. Minister of the Science and Technology of the People's Republic of China, National Key Technology R&D Program (ref: 2006BA101A11)
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Trial website
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Publications
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Contact name
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Prof
Wang
Yongjun
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Address
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Department of Neurology of Beijing Tiantan Hospital
Capital Medical University
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City/town
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Beijing
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Zip/Postcode
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100050
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Country
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China
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Sponsor
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Beijing Tian Tan Hospital, Capital Medical University (China)
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Address
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No.6 Tiantanxili
Chongwen District
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City/town
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Beijing
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Zip/Postcode
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100050
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Country
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China
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Date applied
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11/12/2007
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Last edited
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15/05/2008
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Date ISRCTN assigned
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21/12/2007
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