Psychotic DisordersNCT01423669
Epidemiology Study of Psychosis
An observational study of Psychotic Disorders, run by The University of Hong Kong at 1 site in China.
Trial summary
Purpose Psychotic disorders (including schizophrenia) are complex neurobehaviour disorders influenced by genetic, neurodevelopmental, neurochemical, as well as psychosocial factors. Read more about this study
- Who is it for?
- Ages 16 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychotic Disorders
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- Aug 2010to Dec 2013
- Phase
- Observational
- 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 16 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The sample for this survey is planned to represent community dwelling adult population in Hong Kong. The age range will be from 16-75 years. People residing in institutions will not be covered. The survey will adopt a multi-stage sampling design. The sampling frame will consist of a random selection of addresses quarters generated with the help of the Censes and Statistics Department of the Government of Hong Kong SAR. The addresses would be stratified with geographical location and nature of premises. For each address identified, an advance letter with return envelop or contact information will be sent. The advance letter will inform the residents about the nature of the study with an invitation for participation.
Who may be able to join
- This study is part of the Hong Kong Mental Morbidity Survey 2010 , the sampling frame is described as follows.
- The sample for this survey is planned to represent community dwelling adult population in Hong Kong. The age range will be from 16-75 years. People residing in institutions will not be covered. Only Chinese subjects will be recruited. The survey will adopt a multi-stage sampling design. The sampling frame will consist of a random selection of addresses quarters generated with the help of the Censes and Statistics Department of the Government of Hong Kong SAR. The addresses would be stratified with geographical location and nature of premises. For each address identified, an advance letter with return envelop or contact information will be sent. The advance letter will inform the residents about the nature of the study with an invitation for participation. A maximum of five invitations will be sent by post for non-return within three months. A trained lay interviewer will conduct Phase 1 assessment at home visit for each eligible household expressing interest to participate. To avoid inflation of characteristics that may aggregate within families, only one adult aged 16 years or over will be selected randomly for interview in each household.
Who cannot join
- The sample frame of the study is described above.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The University of Hong Kong
Hong Kong
May Mei-ling Lam, MBBS, 28554488
About this study
Official title: The Hong Kong Morbidity Survey 2010 Part 3: Epidemiology Study of Psychosis Disorder and Sub-clinical Psychotic Experiences
Purpose Psychotic disorders (including schizophrenia) are complex neurobehaviour disorders influenced by genetic, neurodevelopmental, neurochemical, as well as psychosocial factors. Despite significant progresses in pharmacotherapy, the disorder often results in long-term disability (ranked globally amongst the top ten leading causes of disability-adjusted life years, DALYS), often associated with extensive cost, burden, morbidity and mortality.
Objective / hypothesis The study aims to (1) measure the prevalence of psychotic symptoms in the Hong Kong population; (2) explore associated risk and protective factors for the expression of psychotic symptoms; (3) characterize the functional disability in people with psychotic symptoms; and (4) study the determinant of clinical presentation or non-presentation in people with psychotic symptoms.
Read more
Design, subjects and study instrument The survey will be conducted with a two-phase design. The first phase interviews will include approximately 5,000 subjects with structured assessments serving diagnostic criteria for CMD, screening instruments for psychotic disorder, substance misuse and suicidal behaviours, functioning, service use and demographics. The second phase comprises of clinician interviews for psychotic disorder and "at risk mental state" and other variables including neurocognitive, help seeking, stigma and well-being.
Analysis Prevalence estimates will be weighted, expressed as rates and confidence intervals. Comorbidity will be estimated using Latent Class Analysis (LCA) Logistic regression will be used to identify significant factors associated with mental disorders.
Read the detailed description
Psychotic disorders (including schizophrenia) are complex neurobehaviour disorders influenced by genetic, neurodevelopmental, neurochemical, as well as psychosocial factors. Amongst these risk factors, recent findings have highlighted the roles of immigration, urban upbringing, high paternal age, psychoactive substance abuse, as well as stressful early experiences. Despite significant progresses in pharmacotherapy, the disorder often result in long-term disability ranked globally amongst the top ten leading causes of disability-adjusted life years (DALYS, WHO). The World health Organization concludes that the burden and human suffering associated with psychosis is extensive and results in high service and societal costs. Identification and treatment of psychotic disorders (sometimes referred to as Severe Mental Illness, or SMI) is a priority in most mental health services worldwide. However such efforts are challenging because of the help-seeking is severely compromised by reluctance, stigmatization, lack of knowledge, and poor accessibility. This has resulted in long delays before treatment, as well as lack of information about the community prevalence, and associated disability and risk factors for psychosis (ref DUP paper). Availability of these data for Hong Kong will facilitate service planning, early detection and intervention efforts, as well as the consideration of population level preventative strategies.
Availability data suggest that the prevalence of psychosis in the community is substantially higher (5.5-28%, vanos 09) than the prevalence of treated disorder (1-3.5%, vanos09 ), raising important questions about the what determines whether and when psychotic disorders are intercepted in a particular service setting. It is vital to also to obtain information about the untreated cases, in terms of risk factors and protective factors, disability, as well as obstacles to help-seeking.
Community level data for psychotic disorders in Hong Kong is sparse and there has been no territory-wide population-level epidemiology. The Hong Kong population has several distinctive features which are of particular scientific interest and public health concern in relation to psychosis. Although the overall prevalence of substance abuse is low, there is disproportionate use of ketamine in Hong Kong, which interferes with glutaminergic neurotransmission. The relationship between ketamine use and risk for psychosis is of aetiological and clinical interest. In addition, the unique societal context of Hong Kong has resulted in a high proportion of immigrants from China. Moreover, a cohort of people with relatively high paternal age is entering the risk period of developing psychotic disorders (resulting from older man from Hong Kong and younger women from neighbouring parts of China in the previous decades).
Previous relevant study included a district survey, which was more than a quarter of a century old, and was of limited generalization value because of the uneven socioeconomic distribution amongst Hong Kong's 18 districts, resulting in likely uneven distribution of individual with psychosis amongst them. Other relevant data included data of treated new onset cases from Hong Kong's early intervention service (EASY, annual incidence of at least 600 cases under 25, and estimated 1200-1500 in all age groups), with the limitations of treated incidence discussed above.
The investigators propose a territory-wide epidemiological study of psychosis. The study aims to (1) measure the prevalence of psychotic symptoms in the Hong Kong population; (2) explore associated risk and protective factors for the expression of psychotic symptoms; (3) characterize the functional disability in people with psychotic symptoms; and (4) study the determinant of clinical presentation or non-presentation in people with psychotic symptoms.
- Conditions
- Psychotic Disorders
- Keywords
- Psychotic Disorders
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Community dwelling adult population | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Level
Social and Occupational Functioning Assessment Scale (SOFAS)
Measured: Screening
Secondary outcomes (2)
Quality of Life
Multidimensional Scale of Perceived Social Support (MSPSS)
Measured: Screening
Symptomatology
Psychosis Screening Questionnaire (PSQ) Beck Scale for Suicide Ideation (BSS) Beck Hopelessness Scale (BHS) Substance Misuse and Dependence Alcohol Use Disorders Identification Test (AUDIT) \& Severity of Alcohol Dependence Questionnaire
Measured: Screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2011 (estimated)
- Study startAug 2010
- Primary completionAug 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychotic DisordersStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Queen Mary Hospital, Hong Kong, Kowloon Hospital, Hong Kong, Castle Peak Hospital, North District Hospital, Shatin Hospital, Tai Po Hospital, Kwai Chung Hospital, Prince of Wales Hospital, Shatin, Hong Kong
- Investigators
- May Mei-ling LAM, MBBS, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01423669
- Sponsor's protocol ID
- Epi-2010
- Status last verified
- Aug 2011
- First submitted
- 10 Aug 2011
- Last updated
- 26 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Hong Kong Morbidity Survey 2010 Part 3: Epidemiology Study of Psychosis Disorder and Sub-clinical Psychotic Experiences
- ClinicalTrials.gov ID
- NCT01423669
- Acronym / sponsor ID
- Epi-2010
- Conditions
- Psychotic Disorders
- Keywords
- Psychotic Disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Queen Mary Hospital, Hong Kong, Kowloon Hospital, Hong Kong, Castle Peak Hospital, North District Hospital, Shatin Hospital, Tai Po Hospital, Kwai Chung Hospital, Prince of Wales Hospital, Shatin, Hong Kong
- Study start
- Aug 2010
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 26 Aug 2011 (estimated)
- 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.
Purpose Psychotic disorders (including schizophrenia) are complex neurobehaviour disorders influenced by genetic, neurodevelopmental, neurochemical, as well as psychosocial factors. Despite significant progresses in pharmacotherapy, the disorder often results in long-term disability (ranked globally amongst the top ten leading causes of disability-adjusted life years, DALYS), often associated with extensive cost, burden, morbidity and mortality.
Objective / hypothesis The study aims to (1) measure the prevalence of psychotic symptoms in the Hong Kong population; (2) explore associated risk and protective factors for the expression of psychotic symptoms; (3) characterize the functional disability in people with psychotic symptoms; and (4) study the determinant of clinical presentation or non-presentation in people with psychotic symptoms.
Design, subjects and study instrument The survey will be conducted with a two-phase design. The first phase interviews will include approximately 5,000 subjects with structured assessments serving diagnostic criteria for CMD, screening instruments for psychotic disorder, substance misuse and suicidal behaviours, functioning, service use and demographics. The second phase comprises of clinician interviews for psychotic disorder and "at risk mental state" and other variables including neurocognitive, help seeking, stigma and well-being.
Analysis Prevalence estimates will be weighted, expressed as rates and confidence intervals. Comorbidity will be estimated using Latent Class Analysis (LCA) Logistic regression will be used to identify significant factors associated with mental disorders.
Detailed description
Psychotic disorders (including schizophrenia) are complex neurobehaviour disorders influenced by genetic, neurodevelopmental, neurochemical, as well as psychosocial factors. Amongst these risk factors, recent findings have highlighted the roles of immigration, urban upbringing, high paternal age, psychoactive substance abuse, as well as stressful early experiences. Despite significant progresses in pharmacotherapy, the disorder often result in long-term disability ranked globally amongst the top ten leading causes of disability-adjusted life years (DALYS, WHO). The World health Organization concludes that the burden and human suffering associated with psychosis is extensive and results in high service and societal costs. Identification and treatment of psychotic disorders (sometimes referred to as Severe Mental Illness, or SMI) is a priority in most mental health services worldwide. However such efforts are challenging because of the help-seeking is severely compromised by reluctance, stigmatization, lack of knowledge, and poor accessibility. This has resulted in long delays before treatment, as well as lack of information about the community prevalence, and associated disability and risk factors for psychosis (ref DUP paper). Availability of these data for Hong Kong will facilitate service planning, early detection and intervention efforts, as well as the consideration of population level preventative strategies.
Availability data suggest that the prevalence of psychosis in the community is substantially higher (5.5-28%, vanos 09) than the prevalence of treated disorder (1-3.5%, vanos09 ), raising important questions about the what determines whether and when psychotic disorders are intercepted in a particular service setting. It is vital to also to obtain information about the untreated cases, in terms of risk factors and protective factors, disability, as well as obstacles to help-seeking.
Community level data for psychotic disorders in Hong Kong is sparse and there has been no territory-wide population-level epidemiology. The Hong Kong population has several distinctive features which are of particular scientific interest and public health concern in relation to psychosis. Although the overall prevalence of substance abuse is low, there is disproportionate use of ketamine in Hong Kong, which interferes with glutaminergic neurotransmission. The relationship between ketamine use and risk for psychosis is of aetiological and clinical interest. In addition, the unique societal context of Hong Kong has resulted in a high proportion of immigrants from China. Moreover, a cohort of people with relatively high paternal age is entering the risk period of developing psychotic disorders (resulting from older man from Hong Kong and younger women from neighbouring parts of China in the previous decades).
Previous relevant study included a district survey, which was more than a quarter of a century old, and was of limited generalization value because of the uneven socioeconomic distribution amongst Hong Kong's 18 districts, resulting in likely uneven distribution of individual with psychosis amongst them. Other relevant data included data of treated new onset cases from Hong Kong's early intervention service (EASY, annual incidence of at least 600 cases under 25, and estimated 1200-1500 in all age groups), with the limitations of treated incidence discussed above.
The investigators propose a territory-wide epidemiological study of psychosis. The study aims to (1) measure the prevalence of psychotic symptoms in the Hong Kong population; (2) explore associated risk and protective factors for the expression of psychotic symptoms; (3) characterize the functional disability in people with psychotic symptoms; and (4) study the determinant of clinical presentation or non-presentation in people with psychotic symptoms.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Community dwelling adult population | – | – |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The sample for this survey is planned to represent community dwelling adult population in Hong Kong. The age range will be from 16-75 years. People residing in institutions will not be covered. The survey will adopt a multi-stage sampling design. The sampling frame will consist of a random selection of addresses quarters generated with the help of the Censes and Statistics Department of the Government of Hong Kong SAR. The addresses would be stratified with geographical location and nature of premises. For each address identified, an advance letter with return envelop or contact information will be sent. The advance letter will inform the residents about the nature of the study with an invitation for participation.
Key inclusion criteria (2 listed)
- This study is part of the Hong Kong Mental Morbidity Survey 2010 , the sampling frame is described as follows.
- The sample for this survey is planned to represent community dwelling adult population in Hong Kong. The age range will be from 16-75 years. People residing in institutions will not be covered. Only Chinese subjects will be recruited. The survey will adopt a multi-stage sampling design. The sampling frame will consist of a random selection of addresses quarters generated with the help of the Censes and Statistics Department of the Government of Hong Kong SAR. The addresses would be stratified with geographical location and nature of premises. For each address identified, an advance letter with return envelop or contact information will be sent. The advance letter will inform the residents about the nature of the study with an invitation for participation. A maximum of five invitations will be sent by post for non-return within three months. A trained lay interviewer will conduct Phase 1 assessment at home visit for each eligible household expressing interest to participate. To avoid inflation of characteristics that may aggregate within families, only one adult aged 16 years or over will be selected randomly for interview in each household.
Key exclusion criteria (1 listed)
- The sample frame of the study is described above.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Functional Level
Time frame: Screening
Social and Occupational Functioning Assessment Scale (SOFAS)
2 secondary outcomes
Quality of Life
Time frame: Screening
Symptomatology
Time frame: Screening
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2011.
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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.
May Mei-ling LAM, MBBS principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychotic Disorders, run by The University of Hong Kong at 1 site in China.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 26 Aug 2011. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact May Mei-ling LAM, MBBS (28554488, may.ml.lam@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Level (time frame: Screening). 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 26 Aug 2011; AzTrials last refreshed its copy on 6 Nov 2026.