- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06821646
Investigating the Brain's Physiological Responses in Depression and Autism, Using Transcranial Magnetic Stimulation and Electroencephalography
January 9, 2026 updated by: National Taiwan University Hospital
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.
Study Overview
Status
Enrolling by invitation
Conditions
Study Type
Observational
Enrollment (Estimated)
160
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Taipei, Taiwan
- National Taiwan University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
National Taiwan University Hospital
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Autism
|
18F-N-((2-(2-(fluoro-18f)ethoxy)phenyl)methyl)-N-(4-phenoxy-3-pyridinyl) acetamide
single pulse and paired pulse
|
|
Major Depression Disorder
|
18F-N-((2-(2-(fluoro-18f)ethoxy)phenyl)methyl)-N-(4-phenoxy-3-pyridinyl) acetamide
single pulse and paired pulse
|
|
Autism, Major Depression Disorder
|
18F-N-((2-(2-(fluoro-18f)ethoxy)phenyl)methyl)-N-(4-phenoxy-3-pyridinyl) acetamide
single pulse and paired pulse
|
|
Typically Developing Control
|
18F-N-((2-(2-(fluoro-18f)ethoxy)phenyl)methyl)-N-(4-phenoxy-3-pyridinyl) acetamide
single pulse and paired pulse
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Standardized Uptake Value (SUV) of Translocator Protein activity imaged by Positron Emission Tomography (PET)
Time Frame: 1 hour
|
1 hour
|
|
Standardized Uptake Value (SUV) of Translocator Protein activity recorded by transcranial magnetic stimulation and electroencephalography(TMS-EEG)
Time Frame: 2 hours
|
2 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
the total composite scores of multiple scales
Time Frame: 2 hours
|
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)
|
2 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 28, 2024
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Study Registration Dates
First Submitted
February 3, 2025
First Submitted That Met QC Criteria
February 11, 2025
First Posted (Actual)
February 12, 2025
Study Record Updates
Last Update Posted (Estimated)
January 12, 2026
Last Update Submitted That Met QC Criteria
January 9, 2026
Last Verified
December 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Autism Spectrum Disorder
- Mental Disorders
- Mood Disorders
- Neurodevelopmental Disorders
- Child Development Disorders, Pervasive
- Depressive Disorder
- Autistic Disorder
- Depressive Disorder, Major
- Diagnostic Techniques and Procedures
- Diagnosis
- Tomography
- Diagnostic Imaging
- Image Interpretation, Computer-Assisted
- Image Enhancement
- Photography
- Tomography, Emission-Computed
- Radionuclide Imaging
- Diagnostic Techniques, Radioisotope
- Positron-Emission Tomography
Other Study ID Numbers
- 202209019DINB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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