Stem Cell Research on Subjects at Genetic High Risk for Schizophrenia

April 4, 2019 updated by: Seoul National University Hospital

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

  • Subjects at genetic high risk for schizophrenia
  • Healthy control

Description

Inclusion Criteria:

[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

Exclusion Criteria:

  • Significant neurological or medical illness
  • Psychotic symptoms
  • Substance abuse
  • Suicidal risk
  • Blindness or hearing loss
  • Taking aspirin, warfarin or hormonal agents
  • Pregnancy or lactation
  • Susceptibility for keloid formation
  • Allergy to lidocaine
  • History of significant head trauma or loss of consciousness
  • Mental retardation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Healthy Control
Genetic High Risk

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
three years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CAARMS(Comprehensive assessment of at risk mental states)
Time Frame: Baseline
Clinical rating scale for prodromal symptoms of psychosis.
Baseline
PANSS(Positive and Negative Syndrome Scale)
Time Frame: Baseline
Clinical rating scale for the assessment of symptoms of schizophrenia.
Baseline
Neurocognitive function test battery (composite)
Time Frame: Baseline
Neurocognitive function battery comprising tests measuring subjects' intelligence, attention, memory, executive function and social cognitive function.
Baseline
ERP(event-related potential) profile
Time Frame: Baseline
ERP profile including P50, P30 & MMN(Mismatch Negativity).
Baseline
Structural/resting functional MRI data
Time Frame: Baseline
Structural/resting functional MRI data
Baseline
Proton MR spectroscopy
Time Frame: Baseline
Molecular neuroimaging data measuring neurochemical composition profile.
Baseline
PET imaging data
Time Frame: Baseline
PET imaging data measuring receptor availability of GABA(gamma-aminobutyric acid) and Glutamate.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Ministry of Health & Welfare, Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2013

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

September 4, 2013

First Submitted That Met QC Criteria

September 11, 2013

First Posted (Estimate)

September 16, 2013

Study Record Updates

Last Update Posted (Actual)

April 8, 2019

Last Update Submitted That Met QC Criteria

April 4, 2019

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-1207-117-419
  • A120476 (Other Grant/Funding Number: Korean Health Technology R&D Project)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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