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Completed

NCT Number: NCT01943175

Stem Cell Research on Subjects at Genetic High Risk for Schizophrenia

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.

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Key information

Conditions

Genetic High Risk for Schizophrenia Mental Disorders Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Ministry of Health & Welfare, Korea

Registry information

Official study title

Stem Cell-based Approaches to Neuronal Characteristics and Endophenotype of Schizophrenia in Genetic High Risk Subjects

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Sep 16, 2013
Registry last updated
Apr 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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