Clinical trial NCT06063525: Biological Implications of the Overlapping Phenomenon Between Childhood Schizophrenia and Autism Spectrum Disorders-Heterogeneity Approach Rather Than Diagnostic Boundary
Official title: Biological Implications of the Overlapping Phenomenon Between Childhood Schizophrenia and Autism Spectrum Disorders-Heterogeneity Approach Rather Than Diagnostic Boundary
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Schizophrenia
Autism Spectrum Disorder
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2023-10-02
Enrollment: 230
Sex: ALL
Minimum age (years): 15
Maximum age (years): 59
Standard ages: CHILD
ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: as mentioned earlier, patients with schizophrenia and/or autism spectrum disorder

Brief 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


Eligibility criteria: 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

Primary outcomes:
measure: Positive and Negative Syndrome Scale PANSS
timeFrame: 3 years
measure: Autism Diagnostic Observation Schedule
timeFrame: 3 years.
measure: Physical anomalies and craniofacial features
timeFrame: 3 years
measure: Brain structural anatomy with MRI scan
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: