Genetic High Risk for SchizophreniaNCT01943175
Stem Cell Research on Subjects at Genetic High Risk for Schizophrenia
An observational study of Genetic High Risk for Schizophrenia, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study aims at finding endophenotypes of schizophrenia at neuronal level by obtaining stem cells which is derived from adipose cells of subjects with heavy genetic loading for schizophrenia then differentiating them into neuronal cells. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Genetic High Risk for Schizophrenia
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2013to Nov 2015
- 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 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: * Subjects at genetic high risk for schizophrenia * Healthy control
Who may be able to join
- [Subjects at genetic high risk for schizophrenia]
- Healthy without any Axis I mental disorder
- Is a monozygotic twin of a patient with schizophrenia OR Has at least two family members of schizophrenia in the pedigree, including at least one 1st-degree family member
- [Healthy Control]
- Healthy without any Axis I mental disorder
- No family members of schizophrenia in the pedigree to the 3rd degree
Who cannot join
- Significant neurological or medical illness
- Psychotic symptoms
- Substance abuse
- Suicidal risk
- Blindness or hearing loss
- Taking aspirin, warfarin or hormonal agents
Show all 11Show fewer
- Pregnancy or lactation
- Susceptibility for keloid formation
- Allergy to lidocaine
- History of significant head trauma or loss of consciousness
- Mental retardation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Stem Cell-based Approaches to Neuronal Characteristics and Endophenotype of Schizophrenia in Genetic High Risk Subjects
This study aims at finding endophenotypes of schizophrenia at neuronal level by obtaining stem cells which is derived from adipose cells of subjects with heavy genetic loading for schizophrenia then differentiating them into neuronal cells.
- Conditions
- Genetic High Risk for Schizophrenia
- Keywords
- schizophrenia, stem cells, neurons, genetic hish risk for schizophrenia
- Medical subject headings
- Schizophrenia
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 |
|---|---|---|
| Genetic High Risk | Not described | |
| Healthy Control | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Structural and functional characteristics of neurons differentiated from adipose tissue derived stem cells in subjects with genetic high risk for schizophrenia and healthy controls
in vitro measurement of the expression of the neuronal markers for differentiated post-mitotic neuron, GABAergic/Glutamatergic neuron.
The neuronal connectivity, neurites from soma and synaptic protein levels will be assessed. In addition, RNA and proteins expression (e.g. Glutamate/GABA receptors) , physiological function, and in vitro response to antipsychotics will be evaluated.
Measured: three years
Secondary outcomes (7)
CAARMS(Comprehensive assessment of at risk mental states)
Clinical rating scale for prodromal symptoms of psychosis.
Measured: Baseline
PANSS(Positive and Negative Syndrome Scale)
Clinical rating scale for the assessment of symptoms of schizophrenia.
Measured: Baseline
Neurocognitive function test battery (composite)
Neurocognitive function battery comprising tests measuring subjects' intelligence, attention, memory, executive function and social cognitive function.
Measured: Baseline
ERP(event-related potential) profile
ERP profile including P50, P30 \& MMN(Mismatch Negativity).
Measured: Baseline
Structural/resting functional MRI data
Structural/resting functional MRI data
Measured: Baseline
Proton MR spectroscopy
Molecular neuroimaging data measuring neurochemical composition profile.
Measured: Baseline
PET imaging data
PET imaging data measuring receptor availability of GABA(gamma-aminobutyric acid) and Glutamate.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genetic High Risk for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Seoul National 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health & Welfare, Korea
- Responsible party
- Sponsor
- Investigators
- Jun Soo Kwon, M.D., Ph.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01943175
- Sponsor's protocol ID
- H-1207-117-419
- Other IDs
- A120476
- Status last verified
- Dec 2013
- First submitted
- 4 Sep 2013
- Last updated
- 8 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stem Cell-based Approaches to Neuronal Characteristics and Endophenotype of Schizophrenia in Genetic High Risk Subjects
- ClinicalTrials.gov ID
- NCT01943175
- Acronym / sponsor ID
- H-1207-117-419
- Conditions
- Genetic High Risk for Schizophrenia
- Keywords
- schizophrenia, stem cells, neurons, genetic hish risk for schizophrenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Health & Welfare, Korea
- Study start
- Sep 2013 (actual)
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 16 Sep 2013 (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.
This study aims at finding endophenotypes of schizophrenia at neuronal level by obtaining stem cells which is derived from adipose cells of subjects with heavy genetic loading for schizophrenia then differentiating them into neuronal cells.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Genetic High Risk | – | – |
| Healthy Control | – | – |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- * Subjects at genetic high risk for schizophrenia * Healthy control
Key inclusion criteria (6 listed)
- [Subjects at genetic high risk for schizophrenia]
- Healthy without any Axis I mental disorder
- Is a monozygotic twin of a patient with schizophrenia OR Has at least two family members of schizophrenia in the pedigree, including at least one 1st-degree family member
- [Healthy Control]
- Healthy without any Axis I mental disorder
Key exclusion criteria (11 listed)
- Significant neurological or medical illness
- Psychotic symptoms
- Substance abuse
- Suicidal risk
- Blindness or hearing loss
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
Structural and functional characteristics of neurons differentiated from adipose tissue derived stem cells in subjects with genetic high risk for schizophrenia and healthy controls
Time frame: three years
in vitro measurement of the expression of the neuronal markers for differentiated post-mitotic neuron, GABAergic/Glutamatergic neuron. The neuronal connectivity, neurites from soma and synaptic protein levels will be assessed. In addition, RNA and proteins expression (e.g. Glutamate/GABA receptors) , physiological function, and in vitro response to antipsychotics will be evaluated.
7 secondary outcomes
CAARMS(Comprehensive assessment of at risk mental states)
Time frame: Baseline
PANSS(Positive and Negative Syndrome Scale)
Time frame: Baseline
Neurocognitive function test battery (composite)
Time frame: Baseline
ERP(event-related potential) profile
Time frame: Baseline
Structural/resting functional MRI data
Time frame: Baseline
Proton MR spectroscopy
Time frame: Baseline
PET imaging data
Time frame: Baseline
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 8 Apr 2019.
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.
Jun Soo Kwon, M.D., Ph.D. principal investigator
Seoul National University Hospital
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 Genetic High Risk for Schizophrenia, run by Seoul National University Hospital at 1 site in South Korea.
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 6 inclusion and 11 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 8 Apr 2019. 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 South Korea. 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?
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.
What does the primary outcome measure?
Structural and functional characteristics of neurons differentiated from adipose tissue derived stem cells in subjects with genetic high risk for schizophrenia and healthy controls (time frame: three years). 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 8 Apr 2019.