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Current Research

Studies Recruiting Children Include:

The dREMe Study: A trial of donepezil for REM sleep enhancement and improvement of ASD core symptoms 

The purpose of this study is to study the effect of donepezil (Aricept®) on communication and other symptoms of ASD. All children enrolled in this study will receive behavioral and medical tests at a baseline evaluation. Participants will then be seen in the research clinic for periodic follow-up visits to track their developmental progress.

Children 24 to 50 months of age with ASD will be included.

This study requires eight visits to NIH over an 18 month period. Five overnight stays for sleep studies will be required. Your child will receive donepezil or placebo (a capsule without any medication in it) for 6 months. At the end of those six months, your child will stop taking the study capsule. After your child stops taking the capsule, he/she will continue to come to NIH to be tested. We will monitor the children for one year after their last dose of the study capsule to follow their development.

The study is conducted at the NIH Clinical Center in Bethesda, MD. There is no cost to participate and parental permission is required. To find out if you qualify or for more information, please call (301) 435-7962 or email at NIMH-ASD@mail.nih.gov.

Markers of Autism Spectrum Disorders in At-risk Toddlers: A Pilot Study 

Researchers at the National Institute of Mental Health are seeking toddlers 12 or 18 months of age with language delays (i.e., no words at 18 months, limited vocalizations at 12 months) or typical development to participate in a study.

Most children with language delays do not develop autism. However, we hope this study will help inform us about the risk factors.

The study involves an initial screening evaluation that will include a comprehensive caregiver interview and behavioral assessment. Eligible participants will then complete an overnight sleep study/EEG and an MRI scan. Follow-up visits that include behavioral assessment will occur every 6-12 months, with the final study visit occurring at 36 months of age. Participants enrolled at 12 months of age will have 3 follow-up visits (18, 24 months and a final visit at 36 months), and participants enrolled at 18 months will have 2 follow-up visits (24 months and a final visit at 36 months). The final study visit will involve behavioral assessment, sleep/EEG study, and MRI.

This study will involve both outpatient and inpatient visits and will be conducted at the NIH Clinical Center in Bethesda, Maryland.

Compensation will be provided. If you are interested please call 301-435-7962 (TTY: 1-866-411-1010) or e-mail NIMH-ASD@mail.nih.gov..

Near Infrared Spectroscopy in Children With Autism and ADHD 

Researchers at the National Institute of Mental Health are seeking children between the ages of 4 years and 8 years who have been diagnosed with either an Autism Spectrum Disorder (ASD) or Attention Deficit Hyperactivity Disorder (ADHD) to participate in a study examining the use of Near Infra-Red Spectroscopy (NIRS). A group of children who are typically developing will also be recruited as a comparison group.

The purpose of this study is to test whether the NIRS system, which is a functional imaging technique that can monitor brain activity while allowing for movement, can be used to monitor cognitive brain activity and detect differences in children who are diagnosed with an ASD or ADHD. The study involves an initial screening evaluation that will include a comprehensive caregiver interview and behavioral assessment of the child. Eligible participants will then complete a NIRS scan while performing computer generated tasks. One follow-up visit at an 18 month interval will include another administration of the NIRS scan while the participant completes computer generated tasks. This study will involve outpatient visits and will be conducted at the NIH Clinical Center in Bethesda, Maryland.

The results of this study will provide information about the utility of the NIRS technique to detect differences in children with ASD or ADHD and may aid in the understanding of the cognitive functions that underlie these disorders.

Compensation will be provided. If you are interested please call 301-435-7962 (TTY: 1-866-411-1010) or e-mail NIMH-ASD@mail.nih.gov. National Institute of Mental Health, National Institutes of Health, Department of Health & Human Services.

Studies Recruiting Adults Include the Following Collaborations

Neuroimmune Activation in Autism 

People with autism and autism spectrum disorders have problems with communication, behavior, and socializing, and many also have intellectual and developmental disabilities. The cause of autism is not known, but previous research has suggested an association between autism and immune changes in the brain. Researchers are interested in using the experimental radioactive drug (11C)PBR28, which attaches to a target in the brain that is involved in immune changes. Using positron emission tomography (PET) scanning of people with and without autism, researchers will see if there are greater immune changes in people with autism.

Objectives:

- To determine if positron emission tomography scanning can be used to evaluate changes in an immune system target in the brains of people with autism.

Eligibility:

- Individuals between 18 and 45 years of age who have been diagnosed with either autism or autism spectrum disorders, or are healthy volunteers.

-Individuals must be in good health, with no history of serious head trauma.

Design:

  • Participants will be screened with a physical examination and psychological examination, medical history, questionnaires about behavior and mood, and blood and urine tests.
  • Participants will have two imaging studies of the brain at separate study visits. The first study visit will involve a magnetic resonance imaging (MRI) scan to provide a baseline image of the brain. The second study visit will involve PET scan with the radioactive chemical (11C)PBR28 to study an immune system target (called translocator protein) in the brain. The MRI scan will take about 40 minutes, and the PET scan will take about 2 hours.
Transportation reimbursement may be provided
Compensation is provided for participation.
Call: 301-435-8982
(TTY: 1-866-411-1010)
Email: AutismBrain@mail.nih.gov
http://patientinfo.nimh.nih.gov  or for other studies: www.clinicaltrials.gov 
Please refer to study # 11-M-0118

Protein Synthesis in the Brain of Patients With Fragile X Syndrome 

This research seeks to understand how protein formation in the brain is affected in fragile X syndrome (FXS). Researchers will measure the rate at which the brain makes proteins (protein synthesis) and may identify specific parts of the brain affected in FXS. In the future, measurement of protein synthesis in FXS may help us to develop and test new therapies.

The study enrolls eligible young mean with FXS, ages 18-24, from around the world, and includes one visit, lasting several days, to the NIH Clinical Center in Bethesda, Maryland. Study Includes: Assessment by physicians, blood draws, two brain scans (PET & MRI), and possible sedation. The cost of travel, food, and lodging, are covered and include the study participant and one or two accompanying family members. Compensation is paid for your time and assistance.

Please consider enrolling your child in our clinical study of FXS. If you would like to participate, or would simply like to have more information:, please call Inna Loutaev, +1 301 496 4707, or E-mail loutaev.inna@nih.gov