SchizophreniaNCT00172497
Aggressive Acts Among Patients With Schizophrenia
An observational study of Schizophrenia, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The purpose of this series of study has a many-fold intention depicted as follows: to describe and characterize schizophrenic patients' aggressive acts in hospital and community, to identify and specify heterogeneity in their structure, and to look for and set up risk factors for prevention. Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Schizophrenia
- How many people
- 450 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2001to Oct 2005
- 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 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with clinical diagnosis of schizophrenia spectrum, fulfilling the diagnostic criteria of the 4th version of Diagnostic and Statistical Manual (DSM-IV)(APA, 1994)were recruited as study subjects, after signing informed consent. Their families, including their siblings and family caregivers, were also recruited in the study.
Who cannot join
- Exclusion criteria of the patient samples include co-mobility with mental retardation, personality disorder, organic brain disorders, and alcohol or substance abuse/ dependence.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study of the Aggressive Acts Among Patients With Schizophrenia
The purpose of this series of study has a many-fold intention depicted as follows: to describe and characterize schizophrenic patients' aggressive acts in hospital and community, to identify and specify heterogeneity in their structure, and to look for and set up risk factors for prevention. This study investigates four major issues: (1) Establishing an objective behavior rating scale for measuring aggressive acts; (2) Understanding the characteristics and incidence of aggressive acts by patients with schizophrenia; (3) Exploration of the heterogeneous structure of aggressive acts by patients with schizophrenia; and (4) Identifying the risk factors of aggressive acts of patients with schizophrenia.
Read the detailed description
Psychiatric patients' aggressive acts can occur frequently and are recognized as a significant problem in psychiatric services. Understanding of aggressive acts in clinical settings and community is still incomplete and the clinical care of aggressive acts remains unsatisfactory. This study investigates four major issues: (1) Establishing an objective behavior rating scale for measuring aggressive acts; (2) Understanding the characteristics and incidence of aggressive acts by patients with schizophrenia; (3) Exploration of the heterogeneous structure of aggressive acts by patients with schizophrenia; and (4) Identifying the risk factors of aggressive acts of patients with schizophrenia. At first, the content validity, construct validity, and internal consistency of the Chinese version of Violence Scale were examined. Both of retrospective survey and prospective panel design were used for data collection. Patients fulfilling the DSM-IV criteria of schizophrenia in hospital and community, and their siblings and family caregivers, were recruited as different phases of study subjects, after signing informed consent for understanding their past history, prospective occurrence of aggressive acts, and the related risk factors. It is therefore to establish objective measures and to develop insights into the heterogeneity and related risk factors of aggressive acts, for improvement in the management and prevention of aggressive acts.
- Conditions
- Schizophrenia
- Keywords
- aggressive acts
- Medical subject headings
- Schizophrenia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startAug 2001
- Study completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Defined population
- Time perspective
- Other
- Enrolment
- 450 participants
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Investigators
- Shing-Chia Chen, Ph.D., Principal investigator, School of Nursing, College of Medicine, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00172497
- Sponsor's protocol ID
- 9361700926
- Status last verified
- Aug 2001
- First submitted
- 12 Sep 2005
- Last updated
- 15 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Aggressive Acts Among Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT00172497
- Acronym / sponsor ID
- 9361700926
- Conditions
- Schizophrenia
- Keywords
- aggressive acts
- Study type
- Observational
- Recruitment status
- Suspended
- Enrolment
- 450 participants
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Aug 2001
- Study completion
- Oct 2005
- First posted
- 15 Sep 2005 (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.
The purpose of this series of study has a many-fold intention depicted as follows: to describe and characterize schizophrenic patients' aggressive acts in hospital and community, to identify and specify heterogeneity in their structure, and to look for and set up risk factors for prevention. This study investigates four major issues: (1) Establishing an objective behavior rating scale for measuring aggressive acts; (2) Understanding the characteristics and incidence of aggressive acts by patients with schizophrenia; (3) Exploration of the heterogeneous structure of aggressive acts by patients with schizophrenia; and (4) Identifying the risk factors of aggressive acts of patients with schizophrenia.
Detailed description
Psychiatric patients' aggressive acts can occur frequently and are recognized as a significant problem in psychiatric services. Understanding of aggressive acts in clinical settings and community is still incomplete and the clinical care of aggressive acts remains unsatisfactory. This study investigates four major issues: (1) Establishing an objective behavior rating scale for measuring aggressive acts; (2) Understanding the characteristics and incidence of aggressive acts by patients with schizophrenia; (3) Exploration of the heterogeneous structure of aggressive acts by patients with schizophrenia; and (4) Identifying the risk factors of aggressive acts of patients with schizophrenia. At first, the content validity, construct validity, and internal consistency of the Chinese version of Violence Scale were examined. Both of retrospective survey and prospective panel design were used for data collection. Patients fulfilling the DSM-IV criteria of schizophrenia in hospital and community, and their siblings and family caregivers, were recruited as different phases of study subjects, after signing informed consent for understanding their past history, prospective occurrence of aggressive acts, and the related risk factors. It is therefore to establish objective measures and to develop insights into the heterogeneity and related risk factors of aggressive acts, for improvement in the management and prevention of aggressive acts.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with clinical diagnosis of schizophrenia spectrum, fulfilling the diagnostic criteria of the 4th version of Diagnostic and Statistical Manual (DSM-IV)(APA, 1994)were recruited as study subjects, after signing informed consent. Their families, including their siblings and family caregivers, were also recruited in the study.
Key exclusion criteria (1 listed)
- Exclusion criteria of the patient samples include co-mobility with mental retardation, personality disorder, organic brain disorders, and alcohol or substance abuse/ dependence.
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2005.
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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.
Shing-Chia Chen, Ph.D. principal investigator
School of Nursing, College of Medicine, National Taiwan University
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 Schizophrenia, run by National Taiwan University Hospital at 1 site in Taiwan.
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 1 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: paused, as of the sponsor's last update on 15 Sep 2005. 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 Taiwan. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 15 Sep 2005.