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Enrolling by Invitation

NCT Number: NCT06821646

Investigating the Brain's Physiological Responses in Depression and Autism, Using Transcranial Magnetic Stimulation and Electroencephalography

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.

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Key information

Conditions

Autism Autism Spectrum Disorder Autistic Disorder Child Development Disorders, Pervasive Depressive Disorder Depressive Disorder, Major Major Depressive Disorder (MDD) Mental Disorders Mood Disorders Neurodevelopmental Disorders

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Taiwan University Hospital

Taipei, Taiwan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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

Primary outcomes

  1. Standardized Uptake Value (SUV) of Translocator Protein activity imaged by Positron Emission Tomography (PET)

    Time frame: 1 hour

  2. Standardized Uptake Value (SUV) of Translocator Protein activity recorded by transcranial magnetic stimulation and electroencephalography(TMS-EEG)

    Time frame: 2 hours

Secondary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Collaborators

  • Taipei Veterans General Hospital, Taiwan

Registry information

Official study title

Social Cognition in Major Depression and Autism Spectrum Disorder: Cortical Excitatory-inhibitory Imbalance and Neuromechanism

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 12, 2025
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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