Clinical trial NCT06670040: Theta Burst Stimulation for Refractory Depression in Autism Spectrum Disorder
Official title: Sham-Controlled RTMS for Refractory Depression in Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: ASD
Autism Spectrum Disorder
Autism
Depression - Major Depressive Disorder
MDD
Keywords: ASD
Autism
Autism Spectrum Disorder
MDD
Depression
TMS
TBS
Transcranial Magnetic Stimulation
Theta Burst Stimulation
Major Depressive Disorder
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2024-11-01
Enrollment: 24
Sex: ALL
Minimum age (years): 13
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: It's a randomized controlled trial with active accelerated Theta Burst Stimulation (aTBS) treatment and sham controlled group
Primary purpose: TREATMENT

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

Detailed 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.

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.

Primary outcomes:
measure: 17-item Hamilton Rating Scale for Depression (HDRS)
timeFrame: Completed at Screening, baseline, 2-week, 6-week, and 12-week follow up
measure: NIH Toolbox Cognition Battery
timeFrame: Completed at Screening, 2-week, 6-week, and 12-week follow up
Secondary outcomes:
measure: Electroencephalography (EEG)
timeFrame: Completed at baseline, 2-week, 6-week, and 12-week follow up
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Childrens Hospital Medical Center
state: Ohio
Study officials:
affiliation: Cincinnati Childrens Hospital Medical Center
name: Rana Elmaghraby, MD
role: PRINCIPAL_INVESTIGATOR
References: