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The purpose of this study is to see if administration of donepezil will alter the sleep architecture of children with autism. Donepezil, an acteylcholinesterase inhibitor, is FDA- approved for the treatment of cognitive impairment in Alzheimer’s disease. Donepezil has been shown to increase the amount of time that people spend in REM sleep. This study will determine if donepezil can increase the REM sleep in children with autism who are found to be REM sleep deficient.
Sixteen children (ages 2-10) will be enrolled in a 10-20 week study of donepezil. All children enrolled will have an initial two night sleep evaluation to determine if they are REM sleep deficient. Children who are eligible will receive a comprehensive medical and psychological assessment as well as laboratory tests prior to starting the study medications. The children will take donepezil for at least 10 weeks and possibly for as long as 20 weeks during which time they will have several polysomnograms (sleep studies). The sleep studies will be at roughly monthly intervals and will determine whether the REM sleep is changing. Depending upon response, children will have between three and five visits to the clinical center.
Research evaluations are free of charge and travel expenses to the NIH may be provided. Parents will receive a summary of findings from testing. In order to participate, children should live within a reasonable commuting distance of the NIH campus in Bethesda, MD.
To find out if you qualify or for more information, please call 301-435-6652 or 301-496-5323 or email us at OCDNIMH@intra.nimh.nih.gov.
If your child or adolescent (ages 7 to 17 years old) currently has moderate to severe Obsessive-Compulsive Disorder (OCD) and has not benefited from OCD medication, he or she may be eligible to participate in a research study. We are enrolling youth with 1) a primary diagnosis of OCD, or with 2) both Autism Spectrum Disorder and OCD. We are investigating the medication riluzole. Riluzole is FDA-approved for the treatment of ALS (Lou Gehrig’s Disease)
Participants in the current phase of the study will be randomized to receive either 1) riluzole or 2) a placebo (pill with no active ingredient) for 12 weeks. At the end of the first 12 weeks, all children will have the option of taking riluzole (no chance of placebo) for the next 12 weeks.
Participants will have a day-long assessment that includes comprehensive psychiatric, physical, and laboratory evaluations. Children will then have follow-up evaluations with the physician about every month for 6 months, and again at 9 and at 12 months. Parental consent is required for study participation. There are no costs to participate in the study. Travel assistance may be provided.
Children should continue to be followed by their own physicians while in this study.
To find out if you qualify or for more information, please call 301-435-6652 or 301-496-5323 or email us at OCDNIMH@intra.nimh.nih.gov.
The purpose of this study is to learn more about autism and its subtypes. We will look at several types of medical issues, including immunologic problems. As a "natural history" study, children will be followed over the course of several years. We aim to capture medical problems that may be related to autism over time, and study outcomes in areas such as behavior and language.
Three groups of children age 1-4 years (12 months-60 months) will be included: children with autism, children with developmental delay and typically developing children. Within the autism group, we are specifically interested in both children with a history of early onset of autism, as well as children with a history of regressive autism. An initial comprehensive evaluation will be conducted, and elements of these assessments will be conducted every 6 to 12 months, depending on the child's age. After the screening assessment, participants will have a medical history, physical exam and developmental evaluation. Participants will also have a comprehensive medical workup. Parents of participants will complete questionnaires about family history and their child's development and will be asked to participate in a genetic study.
To find out if you qualify or for more information, please call 301-435-7962 or email at nimh-asd@mail.nih.gov.
To find out if you qualify or for more information, please call 301-435-7962 or email at nimh-asd@mail.nih.gov.
Clinical trials.gov.
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This page was last updated on: December 24, 2008