Stem Cell Research on Subjects at Genetic High Risk for Schizophrenia

Completed

• Conditions: Genetic High Risk for Schizophrenia

• Registration Number: NCT01943175
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-09-04
• Study First Submitted QC: 2013-09-11
• Study First Posted: 2013-09-16
• Status Verified: 2013-12
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Last Update Submitted: 2019-04-04
• Last Update Posted: 2019-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Structural and functional characteristics of neurons differentiated from adipose tissue derived stem cells in subjects with genetic high risk for schizophrenia and healthy controls	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

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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of