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

NCT06063525 | Unknown

• 1 other identifier: 201412165RINB
• Study Type: observational
• Target: 230
• Locations: 0 countries
• Sites: N/A

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

Conditions

Schizophrenia; Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (4)

• 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

• Autism Diagnostic Observation Schedule

  interview with subjects. range from 0 to 8, higher the score, worse the autistic symptoms.

  3 years.

• 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

• 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

Study Arms (3)

childhood onset schizophrenia (COS)

diagnosis of schizophrenia under the age of 13 years.

Other: Structural anatomy

schizophrenia (SZ)

patients with schizophrenia with and age of onset later than 13 years

Other: Structural anatomy

autism spectrum disorder (ASD)

dual diagnosis of schizophrenia and ASD, including SZ with ASD, COS with ASD

Other: Structural anatomy

Interventions

Structural anatomy OTHER

images acquired with 3T MRI system with 32 channel head coil

autism spectrum disorder (ASD); childhood onset schizophrenia (COS); schizophrenia (SZ)

Eligibility Criteria

• Age: 15 Years - 59 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

as mentioned earlier, patients with schizophrenia and/or autism spectrum disorder

You may qualify if:

• 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

You may not qualify if:

• congenital disease
• major physical diseases
• neurodegenerative disorder
• chromosomal aberration

Sponsors & Collaborators

• National Taiwan University Hospital: lead

MeSH Terms

Conditions

Schizophrenia; Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Child Development Disorders, Pervasive; Neurodevelopmental Disorders

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2023
• First Posted: October 2, 2023
• Study Start: February 2, 2015
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: October 18, 2023

Record last verified: 2023-01