Biological Implications of the Overlapping Phenomenon Between Childhood Schizophrenia and Autism Spectrum Disorders-Heterogeneity Approach Rather Than Diagnostic Boundary

Active, not recruiting

• Conditions: Autism Spectrum Disorder; Schizophrenia
• Interventions: Other: Structural anatomy

• Registration Number: NCT06063525
• Lead Sponsor: National Taiwan University Hospital

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-02
• Status Verified: 2023-01
• Study First Submitted: 2023-05-04
• Study First Submitted QC: 2023-09-28
• Study First Posted: 2023-10-02
• Last Update Submitted: 2023-10-17
• Last Update Posted: 2023-10-18
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 230

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
childhood onset schizophrenia (COS)	Structural anatomy	diagnosis of schizophrenia under the age of 13 years.
schizophrenia (SZ)	Structural anatomy	patients with schizophrenia with and age of onset later than 13 years
autism spectrum disorder (ASD)	Structural anatomy	dual diagnosis of schizophrenia and ASD, including SZ with ASD, COS with ASD

Primary Outcome Measures

Name	Time	Method
Autism Diagnostic Observation Schedule	3 years.	interview with subjects. range from 0 to 8, higher the score, worse the autistic symptoms.
Brain structural anatomy with MRI scan	3 years	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.
Physical anomalies and craniofacial features	3 years	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.
Positive and Negative Syndrome Scale PANSS	3 years	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.