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:

  1. 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.
  2. 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.
  3. 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

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • Taiwan
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Autism
Diagnostic test: Positron Emission Tomography (PET)
18F-N-((2-(2-(fluoro-18f)ethoxy)phenyl)methyl)-N-(4-phenoxy-3-pyridinyl) acetamide
Diagnostic test: transcranial magnetic stimulation and electroencephalography(TMS-EEG)
single pulse and paired pulse
Major Depression Disorder
Diagnostic test: Positron Emission Tomography (PET)
18F-N-((2-(2-(fluoro-18f)ethoxy)phenyl)methyl)-N-(4-phenoxy-3-pyridinyl) acetamide
Diagnostic test: transcranial magnetic stimulation and electroencephalography(TMS-EEG)
single pulse and paired pulse
Autism, Major Depression Disorder
Diagnostic test: Positron Emission Tomography (PET)
18F-N-((2-(2-(fluoro-18f)ethoxy)phenyl)methyl)-N-(4-phenoxy-3-pyridinyl) acetamide
Diagnostic test: transcranial magnetic stimulation and electroencephalography(TMS-EEG)
single pulse and paired pulse
Typically Developing Control
Diagnostic test: Positron Emission Tomography (PET)
18F-N-((2-(2-(fluoro-18f)ethoxy)phenyl)methyl)-N-(4-phenoxy-3-pyridinyl) acetamide
Diagnostic test: transcranial magnetic stimulation and electroencephalography(TMS-EEG)
single pulse and paired pulse

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Taiwan University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Taipei Veterans General Hospital, Taiwan

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 28, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 3, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 12, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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