Genetic High Risk for Schizophrenia Clinical Trial
Official title:
Stem Cell-based Approaches to Neuronal Characteristics and Endophenotype of Schizophrenia in Genetic High Risk Subjects
| Verified date | December 2013 |
| Source | Seoul National University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 24 |
| Est. completion date | November 2015 |
| Est. primary completion date | November 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 20 Years to 45 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Seoul National University Hospital | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Seoul National University Hospital | Ministry of Health & Welfare, Korea |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Structural and functional characteristics of neurons differentiated from adipose tissue derived stem cells in subjects with genetic high risk for schizophrenia and healthy controls | 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 | CAARMS(Comprehensive assessment of at risk mental states) | Clinical rating scale for prodromal symptoms of psychosis. | Baseline | |
| Secondary | PANSS(Positive and Negative Syndrome Scale) | Clinical rating scale for the assessment of symptoms of schizophrenia. | Baseline | |
| Secondary | Neurocognitive function test battery (composite) | Neurocognitive function battery comprising tests measuring subjects' intelligence, attention, memory, executive function and social cognitive function. | Baseline | |
| Secondary | ERP(event-related potential) profile | ERP profile including P50, P30 & MMN(Mismatch Negativity). | Baseline | |
| Secondary | Structural/resting functional MRI data | Structural/resting functional MRI data | Baseline | |
| Secondary | Proton MR spectroscopy | Molecular neuroimaging data measuring neurochemical composition profile. | Baseline | |
| Secondary | PET imaging data | PET imaging data measuring receptor availability of GABA(gamma-aminobutyric acid) and Glutamate. | Baseline |