NCT01423669

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

August 10, 2011

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 26, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

August 26, 2011

Status Verified

August 1, 2011

Enrollment Period

3 years

First QC Date

August 10, 2011

Last Update Submit

August 25, 2011

Conditions

Keywords

Psychotic Disorders

Outcome Measures

Primary Outcomes (1)

  • Functional Level

    Social and Occupational Functioning Assessment Scale (SOFAS)

    Screening

Secondary Outcomes (2)

  • Quality of Life

    Screening

  • Symptomatology

    Screening

Study Arms (1)

Community dwelling adult population

Eligibility Criteria

Age16 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • The sample frame of the study is described above.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Hong Kong

Hong Kong, China

RECRUITING

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • May Mei-ling LAM, MBBS

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

May Mei-ling LAM, MBBS

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 10, 2011

First Posted

August 26, 2011

Study Start

August 1, 2010

Primary Completion

August 1, 2013

Study Completion

December 1, 2013

Last Updated

August 26, 2011

Record last verified: 2011-08

Locations