Stem Cell Research on Subjects at Genetic High Risk for Schizophrenia

NCT01943175 | Completed DMC

• 2 other identifiers: H-1207-117-419A120476
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Genetic High Risk for Schizophrenia

Keywords

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

Outcome Measures

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

  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 Outcomes (7)

• CAARMS(Comprehensive assessment of at risk mental states)

  Baseline

• PANSS(Positive and Negative Syndrome Scale)

  Baseline

• Neurocognitive function test battery (composite)

  Baseline

• ERP(event-related potential) profile

  Baseline

• Structural/resting functional MRI data

  Baseline

Study Arms (2)

Genetic High Risk

Healthy Control

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

* Subjects at genetic high risk for schizophrenia * Healthy control

You may qualify if:

• \[Subjects at genetic high risk for schizophrenia\]
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Ministry of Health & Welfare, Korea: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Biospecimen

Retention: SAMPLES WITH DNA

5-10mL of adipose cells in tumescent solution 5-10mL of venous blood

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Jun Soo Kwon, M.D., Ph.D.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2013
• First Posted: September 16, 2013
• Study Start: September 1, 2013
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: April 8, 2019

Record last verified: 2013-12

Locations

KR (1)