A Trial of the Drug Donepezil for Sleep Enhancement and Behavioral Change in Children With Autism
Status:
Terminated
Trial end date:
2015-12-01
Target enrollment:
Participant gender:
Summary
Background:
- Some children with autism spectrum disorders (ASD) do not have normal sleep cycles. Some of
these children spend very little time in the rapid eye movement (REM) stage of sleep. Some
studies suggest that less time in REM sleep can be associated with learning and behavior
problems. Donepezil is a medication used to treat Alzheimer s disease. Donepezil can increase
REM sleep in some adults with different disorders. A small study showed that Donepezil can
also increase REM sleep in children with ASD. Researchers now want to see if Donepezil can
improve communication skills and social interaction in children with ASD. They also want to
see if any change in symptoms seems to come from changes in REM sleep.
Objectives:
- To see if a medication, Donepezil, can improve the way communication skills and social
interaction develop in young children with autism spectrum disorders.
Eligibility:
- Children 22 to 44 months of age with ASD.
Design:
- Participants will be screened with a blood test, heart tests, and a sleep study. During
the sleep study, children will sleep in a darkened room for 2 nights with electrodes on
their body and a tube under their nose. Parents can sleep in the room with their child.
A technician will monitor the room all night.
- Participants will take the study medication once a day.
- Treatment will be monitored at visits every 3 months. At each visit the participant will
take blood tests, heart tests, or behavior tests. Participants will have 2 more sleep
studies.
- Participation will end after 18 months.