Schizophrenia Sib-PairsNCT00155688
A Genetic Linkage Study of Schizophrenia
An observational study of Schizophrenia Sib-Pairs, run by National Taiwan University Hospital.
Trial summary
We propose to study 900 sib-pairs with the disorder. Our Specific Aims are: 1) To clinical assess a pedigree sample having adequate power to detect genes for schizophrenia. 2) To conduct a genome scan to find such loci. 3) To transmit all data to the NIMH designated cell repository and data management centers. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia Sib-Pairs
- How many people
- 2,400 participants
- Where
- No sites listed yet
- Study dates
- Dec 1998to Dec 2002
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Schizophrenia
- Han Chinese population
- Two Schizophrenia siblings, one normal parent and one normal sibling
Who cannot join
None listed.
About this study
We propose to study 900 sib-pairs with the disorder. Our Specific Aims are: 1) To clinical assess a pedigree sample having adequate power to detect genes for schizophrenia. 2) To conduct a genome scan to find such loci. 3) To transmit all data to the NIMH designated cell repository and data management centers. We will attain these goals by achieving the following: 1) From Taiwan and China, we will collect 900 Han Chinese sib-pairs having DSM-IV schizophrenia. 2) We will examine all family members using the Diagnostic Interview for Genetic Study and the Family Interviews for Genetic Study. The PI participated in the development and field testing of these interviews and has an already established training program for their use. They have been translated into Mandarin by the Taiwanese investigators, who have used them in prior studies. 3) Blood samples will be sent to the NIMH designated cell repository for creation of lymphoblastoid cell lines. 4) Clinical Data will be entered using the database software created for the NIMH Human Genetics Initiative. Data will be vetted and sent to the NIMH designated data management center. 5) We will complete a genome scan using 450 markers spaced at an average of 10 cM intervals using markers that have been optimized for use in the Han Chinese population. The scan will be completed with no cost to the NIMH through an agreement with Millennim Pharmaceuticals, a biotechnogy company in the the Boston area that the PI has worked with on a prior genetic linkage study of schizophrenia. All genetic analyses will be approved by our consultant, Eric Lander, PhD. 6) All clinical data will be made available to the scientific community by the end of the funding period. All genotypes wil be available one year after they are created but no later than a year after the funding period. This project as feasible because 1) The PI has already coordinated one multi-site genetic linkage study of schizophrenia and has participated in a second. 2) We have a long-standing relationship with our Taiwanese collaborators and an effective, albeit, more recent working relationship with our Chinese collaborators. 3) We have conservatively estimated that each site has access to more than enough available families having two schizophrenic siblings. 4) The PI's Harvard team has had prior experience collaborating on genotyping and linkage analysis projects with Millennium Pharmaceuticals. This, and Millennium's prior genotyping experience shows that the genotyping phase of the work is feasible.
- Conditions
- Schizophrenia Sib-Pairs
- Keywords
- Schizophrenia, linkage, Taiwan, Han Chinese population
- 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 posted12 Sep 2005 (estimated)
- Study startDec 1998
- Study completionDec 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia Sib-PairsStudies 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
- 2,400 participants
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Hai-Gwo Hwu, Professor, Principal investigator, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00155688
- Sponsor's protocol ID
- 53ml
- Other IDs
- MH 59624-01
- Status last verified
- Dec 1998
- First submitted
- 9 Sep 2005
- Last updated
- 20 Dec 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Genetic Linkage Study of Schizophrenia
- ClinicalTrials.gov ID
- NCT00155688
- Acronym / sponsor ID
- 53ml
- Conditions
- Schizophrenia Sib-Pairs
- Keywords
- Schizophrenia, linkage, Taiwan, Han Chinese population
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,400 participants
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Dec 1998
- Study completion
- Dec 2002
- First posted
- 12 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.
We propose to study 900 sib-pairs with the disorder. Our Specific Aims are: 1) To clinical assess a pedigree sample having adequate power to detect genes for schizophrenia. 2) To conduct a genome scan to find such loci. 3) To transmit all data to the NIMH designated cell repository and data management centers. We will attain these goals by achieving the following: 1) From Taiwan and China, we will collect 900 Han Chinese sib-pairs having DSM-IV schizophrenia. 2) We will examine all family members using the Diagnostic Interview for Genetic Study and the Family Interviews for Genetic Study. The PI participated in the development and field testing of these interviews and has an already established training program for their use. They have been translated into Mandarin by the Taiwanese investigators, who have used them in prior studies. 3) Blood samples will be sent to the NIMH designated cell repository for creation of lymphoblastoid cell lines. 4) Clinical Data will be entered using the database software created for the NIMH Human Genetics Initiative. Data will be vetted and sent to the NIMH designated data management center. 5) We will complete a genome scan using 450 markers spaced at an average of 10 cM intervals using markers that have been optimized for use in the Han Chinese population. The scan will be completed with no cost to the NIMH through an agreement with Millennim Pharmaceuticals, a biotechnogy company in the the Boston area that the PI has worked with on a prior genetic linkage study of schizophrenia. All genetic analyses will be approved by our consultant, Eric Lander, PhD. 6) All clinical data will be made available to the scientific community by the end of the funding period. All genotypes wil be available one year after they are created but no later than a year after the funding period. This project as feasible because 1) The PI has already coordinated one multi-site genetic linkage study of schizophrenia and has participated in a second. 2) We have a long-standing relationship with our Taiwanese collaborators and an effective, albeit, more recent working relationship with our Chinese collaborators. 3) We have conservatively estimated that each site has access to more than enough available families having two schizophrenic siblings. 4) The PI's Harvard team has had prior experience collaborating on genotyping and linkage analysis projects with Millennium Pharmaceuticals. This, and Millennium's prior genotyping experience shows that the genotyping phase of the work is feasible.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Schizophrenia
- Han Chinese population
- Two Schizophrenia siblings, one normal parent and one normal sibling
Key exclusion criteria (0 listed)
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
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2005.
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.
Hai-Gwo Hwu, Professor principal investigator
National Taiwan University
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia Sib-Pairs, run by National Taiwan University Hospital.
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 3 inclusion and 0 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: finished, as of the sponsor's last update on 20 Dec 2005. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 20 Dec 2005.