Theta Burst Stimulation for Refractory Depression in Autism Spectrum Disorder

Launched by CHILDREN'S HOSPITAL MEDICAL CENTER, CINCINNATI · Oct 31, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called accelerated theta burst stimulation (aTBS) to see if it can help reduce depression symptoms in young people with Autism Spectrum Disorder (ASD). The researchers are looking for participants aged 13 to 26 years who have both ASD and major depressive disorder (MDD), and who have not had success with at least one antidepressant medication. To join, participants need to be fluent in English and able to understand and explain the study’s risks and benefits.

Participants in the trial will receive aTBS, which is a non-invasive brain stimulation technique, and they will not need to stop any current medications or therapies they are using, although they should try to keep those stable during the study. It's important to note that individuals with a history of certain medical conditions or who are actively suicidal cannot participate. This study is currently recruiting participants and aims to help find new ways to support young people struggling with depression and ASD.

Gender

ALL

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.