Using theta burst stimulation to treat depression in autistic individuals

Sham-Controlled RTMS for Refractory Depression in Autism Spectrum Disorder

This study is testing if a new brain stimulation treatment can help young people with autism and depression feel better.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 13 Years to 26 Years
• Sex: All
• Sponsor: Children's Hospital Medical Center, Cincinnati (other)
• Locations: 1 site (Cincinnati, Ohio)
• Trial ID: NCT06670040 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of accelerated theta burst stimulation (aTBS) in alleviating depressive symptoms in individuals with autism spectrum disorder (ASD) who also have major depressive disorder (MDD). It involves a double-blind randomized controlled trial comparing aTBS treatment to a sham treatment in participants aged 13 to 26. The study will rigorously assess participants' mental health, cognitive function, and social abilities, while also measuring the neural engagement of the treatment using EEG. The goal is to determine if aTBS can lead to significant improvements in depressive symptoms and overall functioning.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 13 to 26 with a diagnosis of ASD and treatment-resistant major depressive disorder.

Not a fit: Patients who do not have a diagnosis of ASD or major depressive disorder, or those who have not shown treatment resistance to antidepressants, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a rapid and effective intervention for depression in individuals with autism, improving their quality of life.

How similar studies have performed: While the use of theta burst stimulation is a relatively novel approach, preliminary studies in similar populations have shown promise in treating depression.

Eligibility criteria

Inclusion Criteria:

1. 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.
2. Aged 13-26, inclusive.
3. Full-scale intelligence quotient ≥ 70.
4. 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).
5. Diagnosis of MDD based on psychologist diagnosis and DSM-5-based structural diagnostic interview determine via KSADS
6. Exhibiting treatment resistance to at least one antidepressant drug treatment of adequate dose and duration.
7. Symptoms of moderate to severe depression according to Hamilton Depression Rating Scale ≥ 20 which must be maintained through lead-in period.
8. Participants are not required to discontinue current interventions but must agree to attempt to keep medications and other interventions stable during the study.

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 limited to, a history of epilepsy, the presence of metallic foreign bodies, or implanted medical devices (e.g. pacemaker, medical pump).
4. Actively suicidal (i.e., suicidal ideation with plan and intent) or deemed at high risk 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.

Where this trial is running

Cincinnati, Ohio

• Cincinnati Childrens Hospital Medical Center — Cincinnati, Ohio, United States (RECRUITING)

Study contacts

• Principal investigator: Rana Elmaghraby, MD — Cincinnati Childrens Hospital Medical Center
• Study coordinator: Mohana Priya Santhan Ramesh Kumar Padma, Masters

Conditions: ASD, Autism Spectrum Disorder, Autism, Depression - Major Depressive Disorder, MDD, Depression, TMS, TBS