Condition category
Mental and Behavioural Disorders
Date applied
11/12/2007
Date assigned
21/12/2007
Last edited
05/04/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Wang Yongjun

ORCID ID

Contact details

Department of Neurology of Beijing Tiantan Hospital
Capital Medical University
Beijing
100050
China

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 measures

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

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

Sponsor information

Organisation

Beijing Tian Tan Hospital, Capital Medical University (China)

Sponsor details

No.6 Tiantanxili
Chongwen District
Beijing
100050
China

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22672300

Publication citations

  1. 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.

Additional files

Editorial Notes