Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Stem Cell Research on Subjects at Genetic High Risk for Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01943175
Recruitment Status : Completed
First Posted : September 16, 2013
Last Update Posted : April 8, 2019
Sponsor:
Collaborator:
Ministry of Health & Welfare, Korea
Information provided by (Responsible Party):
Seoul National University Hospital

Brief 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.

Condition or disease
Genetic High Risk for Schizophrenia

Layout table for study information
Study Type : Observational
Actual Enrollment : 24 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Stem Cell-based Approaches to Neuronal Characteristics and Endophenotype of Schizophrenia in Genetic High Risk Subjects
Actual Study Start Date : September 2013
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Group/Cohort
Genetic High Risk
Healthy Control



Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. CAARMS(Comprehensive assessment of at risk mental states) [ Time Frame: Baseline ]
    Clinical rating scale for prodromal symptoms of psychosis.

  2. PANSS(Positive and Negative Syndrome Scale) [ Time Frame: Baseline ]
    Clinical rating scale for the assessment of symptoms of schizophrenia.

  3. Neurocognitive function test battery (composite) [ Time Frame: Baseline ]
    Neurocognitive function battery comprising tests measuring subjects' intelligence, attention, memory, executive function and social cognitive function.

  4. ERP(event-related potential) profile [ Time Frame: Baseline ]
    ERP profile including P50, P30 & MMN(Mismatch Negativity).

  5. Structural/resting functional MRI data [ Time Frame: Baseline ]
    Structural/resting functional MRI data

  6. Proton MR spectroscopy [ Time Frame: Baseline ]
    Molecular neuroimaging data measuring neurochemical composition profile.

  7. PET imaging data [ Time Frame: Baseline ]
    PET imaging data measuring receptor availability of GABA(gamma-aminobutyric acid) and Glutamate.


Biospecimen Retention:   Samples With DNA

5-10mL of adipose cells in tumescent solution

5-10mL of venous blood



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
  • Subjects at genetic high risk for schizophrenia
  • Healthy control
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01943175


Locations
Layout table for location information
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Ministry of Health & Welfare, Korea
Investigators
Layout table for investigator information
Principal Investigator: Jun Soo Kwon, M.D., Ph.D. Seoul National University Hospital

Layout table for additonal information
Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01943175     History of Changes
Other Study ID Numbers: H-1207-117-419
A120476 ( Other Grant/Funding Number: Korean Health Technology R&D Project )
First Posted: September 16, 2013    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: December 2013

Keywords provided by Seoul National University Hospital:
schizophrenia
stem cells
neurons
genetic hish risk for schizophrenia

Additional relevant MeSH terms:
Layout table for MeSH terms
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders