SchizophreniaNCT06063525
Biological Implications of the Overlapping Phenomenon Between Childhood Schizophrenia and Autism Spectrum Disorders-Heterogeneity Approach Rather Than Diagnostic Boundary
An observational study of Schizophrenia and Autism Spectrum Disorder, run by National Taiwan University Hospital.
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. Read more about this study
- Who is it for?
- Ages 15 to 59 years
- Conditions the study is for
- Schizophrenia, Autism Spectrum Disorder
- What is being tested?
- Structural anatomy
- How many people
- 230 participants
- Where
- No sites listed yet
- Study dates
- 2 Feb 2015to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 59 years
- All sexes
- Child, Adult
Study population: as mentioned earlier, patients with schizophrenia and/or autism spectrum disorder
Who may be able to join
- 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
Who cannot join
- congenital disease
- major physical diseases
- neurodegenerative disorder
- chromosomal aberration
About this study
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
- Being tested
- Structural anatomy
- Medical subject headings
- Schizophrenia, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structural anatomyOther
images acquired with 3T MRI system with 32 channel head coil
| Study group | Role | What they receive |
|---|---|---|
| childhood onset schizophrenia (COS) | diagnosis of schizophrenia under the age of 13 years. Receives: Other: Structural anatomy | |
| schizophrenia (SZ) | patients with schizophrenia with and age of onset later than 13 years Receives: Other: Structural anatomy | |
| autism spectrum disorder (ASD) | dual diagnosis of schizophrenia and ASD, including SZ with ASD, COS with ASD Receives: Other: Structural anatomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Autism Diagnostic Observation Schedule
interview with subjects. range from 0 to 8, higher the score, worse the autistic symptoms.
Measured: 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.
Measured: 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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2023
- Study start2 Feb 2015
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06063525
- Sponsor's protocol ID
- 201412165RINB
- Status last verified
- Jan 2023
- First submitted
- 4 May 2023
- Last updated
- 18 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biological Implications of the Overlapping Phenomenon Between Childhood Schizophrenia and Autism Spectrum Disorders-Heterogeneity Approach Rather Than Diagnostic Boundary
- ClinicalTrials.gov ID
- NCT06063525
- Acronym / sponsor ID
- 201412165RINB
- Conditions
- Schizophrenia, Autism Spectrum Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 2 Feb 2015 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 2 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| childhood onset schizophrenia (COS) | – | Other: Structural anatomydiagnosis of schizophrenia under the age of 13 years. |
| schizophrenia (SZ) | – | Other: Structural anatomypatients with schizophrenia with and age of onset later than 13 years |
| autism spectrum disorder (ASD) | – | Other: Structural anatomydual diagnosis of schizophrenia and ASD, including SZ with ASD, COS with ASD |
Who may qualify
- Ages
- 15 to 59 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- as mentioned earlier, patients with schizophrenia and/or autism spectrum disorder
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- congenital disease
- major physical diseases
- neurodegenerative disorder
- chromosomal aberration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structural anatomyimages acquired with 3T MRI system with 32 channel head coil | Other | autism spectrum disorder (ASD), childhood onset schizophrenia (COS), schizophrenia (SZ) |
Primary outcome
Positive and Negative Syndrome Scale PANSS
Time frame: 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.
Autism Diagnostic Observation Schedule
Time frame: 3 years.
interview with subjects. range from 0 to 8, higher the score, worse the autistic symptoms.
Physical anomalies and craniofacial features
Time frame: 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.
Brain structural anatomy with MRI scan
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
Related trials for Schizophrenia
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia and Autism Spectrum Disorder, run by National Taiwan University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive and Negative Syndrome Scale PANSS (time frame: 3 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2023.