NCT06670040Completed
Theta Burst Stimulation for Refractory Depression in Autism Spectrum Disorder
Sham-Controlled rTMS for Refractory Depression in Autism Spectrum Disorder
Source: ClinicalTrials.gov · Last updated 23 Oct 2026
Brief summary (registry, in English)
Evaluate the efficacy of accelerated theta burst stimulation (aTBS) in reducing depressive symptoms in autism spectrum disorder (ASD)
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 16 Oct 2024
- Start date
- 16 Sept 2024
- Primary completion date
- 30 May 2026
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Diseases
- Depression, Autism
- NCT number
- NCT06670040
What you commit to
- Study type: Interventional
- Participants enrolled: 20
- From 16 Sept 2024 to the primary completion date, 30 May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participation in an investigational drug trial within the past three months.
- Current use of anticonvulsant, barbiturate, lithium, or benzodiazepine medications.
- Prior rTMS treatment.
Other illness
- Active substance use disorder (excluding tobacco use) within the past 6 months.
- Contraindications to Transcranial Magnetic Stimulation including, but not limited to, a history of epilepsy, the presence of metallic foreign bodies, or implanted medical devices (e.g. pacemaker, medical pump).
Other
- Actively suicidal (i.e., suicidal ideation with plan and intent) or deemed at high risk for suicide.
- For female subjects of childbearing potential, a positive urine pregnancy test.
Who the study is looking for
- Fluent in English and able to volunteer in the informed consent process and provide spontaneous narrative description of key elements, risks, and benefits of the study.
- Aged 13-26, inclusive.
- Full-scale intelligence quotient ≥ 70.
- Diagnosis of ASD using criteria from Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5). Diagnosis will be confirmed by study psychologist/social worker and supported by scoring in the ASD on the Autism Diagnostic Observation Schedule (ADOS-2).
- Diagnosis of MDD based on psychologist diagnosis and DSM-5-based structural diagnostic interview determine via KSADS
- Exhibiting treatment resistance to at least one antidepressant drug treatment of adequate dose and duration.
- Symptoms of moderate to severe depression according to Hamilton Depression Rating Scale ≥ 20 which must be maintained through lead-in period.
- Participants are not required to discontinue current interventions but must agree to attempt to keep medications and other interventions stable during the study.
Age in the registry: 13 years to 26 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cincinnati Childrens Hospital Medical Center Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.