Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
A prospective cohort study on incidence and outcome of patients with post-stroke depression in China
Acronym
PRIOD- China
Study hypothesis
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
Ethics approval
Tiantan Hospital Ethics Committee. Date of approval: 12/05/2008
Study design
Multi-centre, observational, prospective, nested case-control study.
Primary study design
Observational
Secondary study design
Case-control study
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Post-stroke depression
Intervention
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
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
1. Onset: Incidence of depression within 3 months and 6 months of stroke onset
2. Scale score: Score tendency based on HRSD scale within 14 days, 3 months, 6 months, and 1 year of stroke onset
Secondary outcome measures
1. Quality of life: Medical Outcome Study Short Form 36 (SF-36)
2. mRS score
Overall trial start date
10/01/2008
Overall trial end date
01/06/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. New stroke onset
2. Stroke 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
2,500
Participant exclusion criteria
1. Unable to complete examination due to the influence of eyesight, hearing, expression, consciousness, and apprehension
2. Stroke patient presenting no sign or symptom
Recruitment start date
10/01/2008
Recruitment end date
01/06/2009
Locations
Countries of recruitment
China
Trial participating centre
Department of Neurology of Beijing Tiantan Hospital
Beijing
100050
China
Funders
Funder type
Government
Funder name
Wyeth pharmaceuticals
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Minister of the Science and Technology of the People's Republic of China, National Key Technology R&D Program (ref: 2006BA101A11)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22672300
Publication citations
-
Results
Zhang N, Wang CX, Wang AX, Bai Y, Zhou Y, Wang YL, Zhang T, Zhou J, Yu X, Sun XY, Liu ZR, Zhao XQ, Wang YJ, , Time course of depression and one-year prognosis of patients with stroke in mainland China., CNS Neurosci Ther, 2012, 18, 6, 475-481, doi: 10.1111/j.1755-5949.2012.00312.x.