Clinical Trials / Research Studies
Autism Study for Teens and Adults 14 to 25 Years Old
Why are we doing this research?
Cincinnati Children's is conducting a research study to determine whether repetitive transcranial magnetic stimulation (rTMS) is an effective treatment for treatment-resistant major depressive disorder in people with autism. The study involves 15 study visits (some virtual) with TMS treatment, cognitive assessments, physiological measures, and self-report questionnaires.Who can participate?
Teens and young adults 14 to 25 years old who:
- Have been diagnosed on the autism spectrum
- Have failed one or more evidence-based antidepressant treatments (e.g. an SSRI, talk therapy like CBT)
Conditions
- Autism
- Mental Health
What will happen in the study?
This study includes 15 study visits at Cincinnati Children’s over about 16 weeks. There are 3 phases in the study. Here are some of the things that will happen in this study.
If you qualify, you will be randomly assigned (like flipping a coin) to one of two treatment groups (both receiving active rTMS treatment for 2 weeks).
During the first screening phase of 2 weeks, you will:
- Go through the consent process with a research coordinator. *
- Fill out questionnaires. *
- Complete a cognitive assessment.
- Undergo EEG testing with eye-tracking.
- Submit a urine drug screen.
- Be given a Mood Foundations brochure with tips about managing depression.
In the second phase or intervention phase of 2 weeks, you/your child will:
- Receive half-day TMS treatment 5 days a week (M-F) for 2 weeks.
- On days 5 and 10 of the intervention, complete additional questionnaires and an EEG.
In the third phase or follow-up phase, you will attend visits 1, 4, and 12 weeks after your final TMS treatment, and in each one you will be asked to complete a set of questionnaires*, an EEG, physiological measures, and a cognitive assessment.
* Denotes things that can be done remotely
What are the good things that can happen from this research?
You, as the participant, will be receiving a treatment that is FDA approved to treat depression in adults, and it is likely you may receive a benefit from this therapy. However, there is no guarantee that you will benefit from participating in this study.What are the bad things that can happen from this research?
Possible risks and discomforts will be discussed with adult participants, parents or guardians interested in learning more about the study.Will you/your child be paid to be in this research study?
Participants will receive up to $1000 for participation in this study.
Contact
Elizabeth Blank
elizabeth.blank@cchmc.org
513-803-8635
Psychiatry
Cincinnati Children’s Hospital Medical Center
3333 Burnet Ave.
Cincinnati, OH 45229-3039
Study Doctor
Ernest Pedapati, MD
Psychiatry
Cincinnati Children’s Hospital Medical Center
3333 Burnet Avenue, Cincinnati, Ohio 45229-3026
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