Stem Cell Research on Subjects at Genetic High Risk for Schizophrenia

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01943175

Enrollment

Registered

2013-09-16

Start date

2013-09-30

Completion date

2015-11-30

Last updated

2019-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Genetic High Risk for Schizophrenia

Keywords

schizophrenia, stem cells, neurons, genetic hish risk for schizophrenia

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

20 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

South Korea

Outcome results