Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomized Controlled Trial of Donepezil for REM Enhancement and Behavioral Change in Autism
Brief 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.


Options:
A: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: olanzapine (Zyprexa) | Arm Label: 2; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: olanzapine (Zyprexa); Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): 2
B: Arm Label: Memantine 1; Type: EXPERIMENTAL; Interventions: Drug: Memantine Hydrochloride (HCl) | Arm Label: Memantine 2; Type: EXPERIMENTAL; Interventions: Drug: Memantine Hydrochloride (HCl) | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo capsules | Intervention Type: DRUG; Name: Memantine Hydrochloride (HCl); Assigned to Arm(s): Memantine 1 | Intervention Type: DRUG; Name: Memantine Hydrochloride (HCl); Assigned to Arm(s): Memantine 2 | Intervention Type: DRUG; Name: Placebo capsules; Assigned to Arm(s): Placebo
C: Arm Label: Open-Label Donepezil; Type: EXPERIMENTAL; Interventions: Drug: Donepezil | Arm Label: Donepezil - Blinded; Type: EXPERIMENTAL; Interventions: Drug: Donepezil | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Donepezil; Assigned to Arm(s): Donepezil - Blinded, Open-Label Donepezil | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
D: Arm Label: citalopram hydrobromide; Type: EXPERIMENTAL; Interventions: Drug: citalopram hydrobromide | Arm Label: placebo; Type: PLACEBO_COMPARATOR; Interventions: Other: placebo | Intervention Type: DRUG; Name: citalopram hydrobromide; Assigned to Arm(s): citalopram hydrobromide | Intervention Type: OTHER; Name: placebo; Assigned to Arm(s): placebo

Answer: C