Theta Burst Stimulation for Refractory Depression in Autism Spectrum Disorder

Last updated: February 10, 2026
Sponsor: Children's Hospital Medical Center, Cincinnati
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Autism Spectrum Disorder (Asd)

Depression

Autism

Treatment

Transcranial Magnetic Stimulation

Transcranial Magnetic Stimulation Sham

Clinical Study ID

NCT06670040
2023-0682
  • Ages 13-26
  • All Genders

Study Summary

Evaluate the efficacy of accelerated theta burst stimulation (aTBS) in reducing depressive symptoms in autism spectrum disorder (ASD)

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Fluent in English and able to volunteer in the informed consent process and providespontaneous narrative description of key elements, risks, and benefits of the study.

  2. Aged 13-26, inclusive.

  3. Full-scale intelligence quotient ≥ 70.

  4. Diagnosis of ASD using criteria from Diagnostic and Statistical Manual of MentalDisorders, 5th Edition (DSM-5). Diagnosis will be confirmed by studypsychologist/social worker and supported by scoring in the ASD on the AutismDiagnostic Observation Schedule (ADOS-2).

  5. Diagnosis of MDD based on psychologist diagnosis and DSM-5-based structuraldiagnostic interview determine via KSADS

  6. Exhibiting treatment resistance to at least one antidepressant drug treatment ofadequate dose and duration.

  7. Symptoms of moderate to severe depression according to Hamilton Depression RatingScale ≥ 20 which must be maintained through lead-in period.

  8. Participants are not required to discontinue current interventions but must agree toattempt to keep medications and other interventions stable during the study.

Exclusion

Exclusion Criteria:

  1. Participation in an investigational drug trial within the past three months.

  2. Active substance use disorder (excluding tobacco use) within the past 6 months.

  3. Contraindications to Transcranial Magnetic Stimulation including, but not limitedto, a history of epilepsy, the presence of metallic foreign bodies, or implantedmedical devices (e.g. pacemaker, medical pump).

  4. Actively suicidal (i.e., suicidal ideation with plan and intent) or deemed at highrisk for suicide.

  5. Current use of anticonvulsant, barbiturate, lithium, or benzodiazepine medications.

  6. Prior rTMS treatment.

  7. For female subjects of childbearing potential, a positive urine pregnancy test.

Study Design

Total Participants: 24
Treatment Group(s): 2
Primary Treatment: Transcranial Magnetic Stimulation
Phase:
Study Start date:
September 16, 2024
Estimated Completion Date:
April 30, 2026

Study Description

The overall goal of this study is to treat major depressive disorder (MDD) rapidly and effectively in individuals with autism spectrum disorder (ASD). Our central hypothesis is that accelerated theta burst stimulation (aTBS) targeting the left dorsal lateral prefrontal cortex (DLPFC) will significantly improve MDD symptoms and rate of remission compared to sham. We propose a double-blind RCT of 13-to 26-year-old individuals with ASD with MDD to test the efficacy of aTBS (n=12) versus sham (n=12) treatment. Participants will be rigorously characterized, including co-occurring conditions, any concurrent therapies, medications, social function, cognition, and sensory profile. A core battery of assessments will assess the efficacy of the intervention and maintenance of gains with respect to MDD and ASD-specific symptomology. Neural target engagement will be assessed by source-localized Electroencephalography (EEG) connectivity.

Connect with a study center

  • Cincinnati Childrens Hospital Medical Center

    Cincinnati, Ohio 45224
    United States

    Site Not Available

  • Cincinnati Childrens Hospital Medical Center

    Cincinnati 4508722, Ohio 5165418 45224
    United States

    Site Not Available

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