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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06063525
Other study ID # 201412165RINB
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date February 2, 2015
Est. completion date December 31, 2024

Study information

Verified date January 2023
Source National Taiwan University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Complex diseases such as schizophrenia and autism are heterogeneous in clinical presentation and etiology. This high heterogeneity constitutes the challenges for the clinical diagnosis and etiological research, resulting in that the majority of research findings cannot be replicated in the independent samples. For the high comorbid rate between the diagnoses of schizophrenia and autism spectrum disorders (ASD), and the shared neurocognitive deficits, genetic risks, and biological markers between the two disorders, a heterogeneity approach may probably be more promising than to arbitrarily split the two diagnostic categories apart or lump them together for etiological research. In schizophrenia, patients with a very early onset of disease and with preceding neurodevelopmental conditions may imply a different underlying etiology from those with typical onset and without neurodevelopmental conditions. Echoing the evidence that in early onset Parkinson's disease, PARK2 (encoding parkin protein) mutations are successfully reported to be as frequent as 49% with an autosomal-recessive mode of inheritance , representing a specific disease entity of Parkinson's disease. Therefore, it is critical to characterize the clinical phenotypes for this subpopulation of very early onset patients, including their clinical manifestation, disease course, and treatment response, as well as early developmental history and morphological characteristics. These may establish an important base for investigating the etiology and providing adequate clinical care for the heterogeneous syndrome of schizophrenia


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 230
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers
Gender All
Age group 15 Years to 59 Years
Eligibility Inclusion Criteria: - SZ group: schizophrenia onset earlier than 12 years old - COS group: schizophrenia onset later than 12 years old - ASD group: diagnosed with autism spectrum disorder without schizophrenia - Dual group: diagnosed with ASD and SZ Exclusion Criteria: - congenital disease - major physical diseases - neurodegenerative disorder - chromosomal aberration

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Structural anatomy
images acquired with 3T MRI system with 32 channel head coil

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Positive and Negative Syndrome Scale PANSS 33 item scale composed of 7 positive scale, 7 negative scale, 16 general psychopathology, and 3 aggression risk profile. Range from 0 to 7, higher the score, more severe the symptoms are. 3 years
Primary Autism Diagnostic Observation Schedule interview with subjects. range from 0 to 8, higher the score, worse the autistic symptoms. 3 years.
Primary Physical anomalies and craniofacial features 41 qualitative items were used to examine the presence or absence of morphological anomalies and magnitude of anomalies. Minor physical anomalies were rated from 0 to 83, higher the score, greater the anomalies. 3 years
Primary Brain structural anatomy with MRI scan 3 Tesla MRI with a 32-channel head coil was used to collect brain imaging of cortical thickness, cortical volume, white matter volume, gyrification. The MRI structural images will be analyzed using FreeSurfer image analysis suite. 3 years
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