AutismNCT06821646
Investigating the Brain's Physiological Responses in Depression and Autism, Using Transcranial Magnetic Stimulation and Electroencephalography
An observational study of Autism and Major Depressive Disorder (MDD), run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The goal of this observational study is to investigate the brain physiological responses in depression and autism. The main questions aim to answer are: 1. Comparing the ratios of cortical excitation and inhibition among four groups: autism group, autism with depression group, depression group, and normal control… Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism, Major Depressive Disorder (MDD)
- What is being tested?
- Positron Emission Tomography (PET) and transcranial magnetic stimulation and electroencephalography(TMS-EEG)
- How many people
- 160 participants
- Where
- 1 siteTaiwan
- Study dates
- 28 May 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: National Taiwan University Hospital
Who may be able to join
- Autism group : Adults aged 20-50 diagnosed with autism spectrum disorder。Intelligence Quotient(IQ) > 70, with autonomous abilities.
- Autism group with comorbid depression : Adults aged 20-50 diagnosed with autism spectrum disorder. Diagnosed with depression. IQ > 70. Not on antidepressants for at least one week, with autonomous abilities.
- Major depression disorder group : Adults aged 20-50. Diagnosed with major depressive disorder according to Diagnostic and Statistical Manual of Mental Disorders-IV-TR(DSM-IV-TR). IQ > 70. Not on antidepressants for at least one week, with autonomous abilities.
- Typically developing control group : Adults aged 20-50. Never diagnosed with autism spectrum disorder. Never diagnosed with depression. IQ > 70, with autonomous abilities.
Who cannot join
- Previously diagnosed with bipolar disorder, schizophrenia, attention deficit hyperactivity disorder (ADHD), or substance use disorder according to DSM-IV.
- Previously suffered from major medical or neurological diseases.
- Brain structural abnormalities (e.g., brain tumor or arteriovenous malformations) or neurological diseases (e.g., meningitis, encephalitis, stroke, or epilepsy).
- Previously undergone or soon to undergo brain surgery, or have metal implants in the head or neck area, such as neuro-stimulators or cochlear implants.
- Have a cardiac pacemaker.
- Pregnant participants.
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- Participants with strong suicidal intentions.
- Other conditions that render the patient unable to cooperate, such as unsuitability after screening, unstable physical illness, or refusal to sign the informed consent.
- Claustrophobia, unable to undergo positron emission tomography(PET) and functional magnetic resonance imaging (fMRI) scans.
- Taking medications that may affect Excitatory/inhibitory balance (E/I balance).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Social Cognition in Major Depression and Autism Spectrum Disorder: Cortical Excitatory-inhibitory Imbalance and Neuromechanism
The goal of this observational study is to investigate the brain physiological responses in depression and autism. The main questions aim to answer are:
- Comparing the ratios of cortical excitation and inhibition among four groups: autism group, autism with depression group, depression group, and normal control group using Transcranial magnetic stimulation and electroencephalography (TMS-EEG). This study explores the relationship between the ratios of cortical excitation and inhibition and the severity of clinical symptoms.
- Comparing the brain inflammation among four groups: autism group, autism with depression group, depression group, and normal control group using Positron emission tomography (PET). This study investigates the relationship between brain inflammation and the severity of clinical symptoms.
- The mutual influence between the severity of brain inflammation and Excitatory/inhibitory imbalance (E/I imbalance).
Participants will receive clinical assessment, neurocognitive function tests, TMS-EEG, gamma oscillation, and PET examinations.
- Conditions
- Autism, Major Depressive Disorder (MDD)
- Being tested
- Positron Emission Tomography (PET), transcranial magnetic stimulation and electroencephalography(TMS-EEG)
- Keywords
- Autism, Major Depressive Disorder, FEPPA PET, TMS-EEG
- Medical subject headings
- Autistic Disorder, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positron Emission Tomography (PET)Diagnostic test
18F-N-((2-(2-(fluoro-18f)ethoxy)phenyl)methyl)-N-(4-phenoxy-3-pyridinyl) acetamide
transcranial magnetic stimulation and electroencephalography(TMS-EEG)Diagnostic test
single pulse and paired pulse
| Study group | Role | What they receive |
|---|---|---|
| Autism | Not described Receives: Diagnostic Test: Positron Emission Tomography (PET); Diagnostic Test: transcranial magnetic stimulation and electroencephalography(TMS-EEG) | |
| Major Depression Disorder | Not described Receives: Diagnostic Test: Positron Emission Tomography (PET); Diagnostic Test: transcranial magnetic stimulation and electroencephalography(TMS-EEG) | |
| Autism, Major Depression Disorder | Not described Receives: Diagnostic Test: Positron Emission Tomography (PET); Diagnostic Test: transcranial magnetic stimulation and electroencephalography(TMS-EEG) | |
| Typically Developing Control | Not described Receives: Diagnostic Test: Positron Emission Tomography (PET); Diagnostic Test: transcranial magnetic stimulation and electroencephalography(TMS-EEG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standardized Uptake Value (SUV) of Translocator Protein activity imaged by Positron Emission Tomography (PET)
Measured: 1 hour
Standardized Uptake Value (SUV) of Translocator Protein activity recorded by transcranial magnetic stimulation and electroencephalography(TMS-EEG)
Measured: 2 hours
Secondary outcomes (1)
the total composite scores of multiple scales
Adult Autism Spectrum Quotient (AQ), Empathy Quotient(EQ), Social Responsiveness Scale(SRS), Beck Depression Inventory(BDI), Beck Anxiety Inventory(BAI), The Schutte's Emotion Intelligence Scale(SEIS), Depression and Somatic Symptoms Scale(DSSS), Snaith-Hamilton Pleasure Scale(SHAPS)
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start28 May 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Taipei Veterans General Hospital, Taiwan
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06821646
- Sponsor's protocol ID
- 202209019DINB
- Status last verified
- Dec 2025
- First submitted
- 3 Feb 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Cognition in Major Depression and Autism Spectrum Disorder: Cortical Excitatory-inhibitory Imbalance and Neuromechanism
- ClinicalTrials.gov ID
- NCT06821646
- Acronym / sponsor ID
- 202209019DINB
- Conditions
- Autism, Major Depressive Disorder (MDD)
- Keywords
- Autism, Major Depressive Disorder, FEPPA PET, TMS-EEG
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Taipei Veterans General Hospital, Taiwan
- Study start
- 28 May 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Feb 2025 (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.
The goal of this observational study is to investigate the brain physiological responses in depression and autism. The main questions aim to answer are:
- Comparing the ratios of cortical excitation and inhibition among four groups: autism group, autism with depression group, depression group, and normal control group using Transcranial magnetic stimulation and electroencephalography (TMS-EEG). This study explores the relationship between the ratios of cortical excitation and inhibition and the severity of clinical symptoms.
- Comparing the brain inflammation among four groups: autism group, autism with depression group, depression group, and normal control group using Positron emission tomography (PET). This study investigates the relationship between brain inflammation and the severity of clinical symptoms.
- The mutual influence between the severity of brain inflammation and Excitatory/inhibitory imbalance (E/I imbalance).
Participants will receive clinical assessment, neurocognitive function tests, TMS-EEG, gamma oscillation, and PET examinations.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Autism | – | Diagnostic Test: Positron Emission Tomography (PET), Diagnostic Test: transcranial magnetic stimulation and electroencephalography(TMS-EEG) |
| Major Depression Disorder | – | Diagnostic Test: Positron Emission Tomography (PET), Diagnostic Test: transcranial magnetic stimulation and electroencephalography(TMS-EEG) |
| Autism, Major Depression Disorder | – | Diagnostic Test: Positron Emission Tomography (PET), Diagnostic Test: transcranial magnetic stimulation and electroencephalography(TMS-EEG) |
| Typically Developing Control | – | Diagnostic Test: Positron Emission Tomography (PET), Diagnostic Test: transcranial magnetic stimulation and electroencephalography(TMS-EEG) |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- National Taiwan University Hospital
Key inclusion criteria (4 listed)
- Autism group : Adults aged 20-50 diagnosed with autism spectrum disorder。Intelligence Quotient(IQ) > 70, with autonomous abilities.
- Autism group with comorbid depression : Adults aged 20-50 diagnosed with autism spectrum disorder. Diagnosed with depression. IQ > 70. Not on antidepressants for at least one week, with autonomous abilities.
- Major depression disorder group : Adults aged 20-50. Diagnosed with major depressive disorder according to Diagnostic and Statistical Manual of Mental Disorders-IV-TR(DSM-IV-TR). IQ > 70. Not on antidepressants for at least one week, with autonomous abilities.
- Typically developing control group : Adults aged 20-50. Never diagnosed with autism spectrum disorder. Never diagnosed with depression. IQ > 70, with autonomous abilities.
Key exclusion criteria (10 listed)
- Previously diagnosed with bipolar disorder, schizophrenia, attention deficit hyperactivity disorder (ADHD), or substance use disorder according to DSM-IV.
- Previously suffered from major medical or neurological diseases.
- Brain structural abnormalities (e.g., brain tumor or arteriovenous malformations) or neurological diseases (e.g., meningitis, encephalitis, stroke, or epilepsy).
- Previously undergone or soon to undergo brain surgery, or have metal implants in the head or neck area, such as neuro-stimulators or cochlear implants.
- Have a cardiac pacemaker.
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 |
|---|---|---|
| Positron Emission Tomography (PET)18F-N-((2-(2-(fluoro-18f)ethoxy)phenyl)methyl)-N-(4-phenoxy-3-pyridinyl) acetamide | Diagnostic test | Autism, Autism, Major Depression Disorder, Major Depression Disorder, Typically Developing Control |
| transcranial magnetic stimulation and electroencephalography(TMS-EEG)single pulse and paired pulse | Diagnostic test | Autism, Autism, Major Depression Disorder, Major Depression Disorder, Typically Developing Control |
Primary outcome
Standardized Uptake Value (SUV) of Translocator Protein activity imaged by Positron Emission Tomography (PET)
Time frame: 1 hour
Standardized Uptake Value (SUV) of Translocator Protein activity recorded by transcranial magnetic stimulation and electroencephalography(TMS-EEG)
Time frame: 2 hours
1 secondary outcome
the total composite scores of multiple scales
Time frame: 2 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism and Major Depressive Disorder (MDD), run by National Taiwan University Hospital at 1 site in Taiwan.
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 10 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: enrolling by invitation, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
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?
Standardized Uptake Value (SUV) of Translocator Protein activity imaged by Positron Emission Tomography (PET) (time frame: 1 hour). The study lists 2 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 12 Jan 2026.