Dear Parent or Legal Guardian,
Children’s Hospital of Michigan is committed to providing you with the best healthcare for kids! In addition to providing you with the most up to date health care, we actively pursue involvement in research studies to further our knowledge base and improve your care. Dr. Diane Chugani is currently enrolling children in the following research study: “Early Pharmacotherapy Guided by Biomarkers in Autism.”
The purpose of this research study is to test the safety and effectiveness of buspirone when used to treat the core features of autism. This 24-week study involves random assignment to placebo, 2.5 mg buspirone, or 5.0 mg buspirone. This research study will also use PET (Positron Emission Tomography) scans to look at whether the brain chemical serotonin may help explain why the medication may be useful for treating autism. To be eligible for this study, the participant must:
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Be between the ages of 2 to 6 years, inclusive
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Meet diagnostic criteria for autism
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Not have any other significant medical conditions or neurological disorders
If the child has not been previously diagnosed as having autism, a study psychiatrist will conduct diagnostic tests to confirm eligibility in the study. We will summarize our findings for all families involved and send a copy to any clinician authorized by the parent.
If you choose to enter and your child qualifies, participation includes a 2 week Screening Phase and a 24 week Treatment Phase. You and your child will be asked to come to the clinic a total of 9 times with 6 telephone visits in between clinic visits. A variety of assessments will happen at these visits, including questionnaires for you and testing of your child. He/she will also need to have blood drawn 5 times throughout the study.
There is also an open label extension portion to the study where all participants will receive active study medication. This open label part of the study will last for an additional 24 weeks. There are a total of 7 clinic visits, 6 telephone visits, and 3 blood draws throughout the open label study.
All study-related evaluations and medications are provided at no cost. In addition, families who participate will be reimbursed for each visit. There are risks, which will be explained before anyone agrees to participate. If you have an interest in the above study, or have any questions, please feel free to call Jamie Katusin at (313) 745-0148 for further information.
Thank you for your continued commitment to Children’s Hospital of Michigan.
Sincerely,
Jamie Katusin
Research Coordinator
Children’s Hospital of Michigan, 3N47
3901 Beaubien Blvd.
Detroit, MI 48124
jkatusin@med.wayne.edu