Studying Childhood-onset Behavioral, Psychiatric, and Developmental Disorders
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01778504|
Recruitment Status : Recruiting
First Posted : January 29, 2013
Last Update Posted : March 29, 2018
- Many psychiatric, behavioral, and developmental disorders are genetic. This means that they tend to run in families. Some begin in childhood, while others do not appear until adulthood. Researchers want to look at people of all ages who have these disorders that started in childhood. They will also look at relatives of people with these disorders. This information will allow doctors to learn more about childhood behavioral problems and how they are inherited. It may also help doctors treat those disorders.
- To study the onset and treatment of childhood behavioral, psychiatric, and developmental disorders.
- Individuals of any age who have a psychiatric, autism spectrum, or developmental disorder, or other behavioral problems.
- Family members of individuals with the above disorders. This group may include parents, grandparents, siblings, aunts/uncles, cousins, and children.
- Participants will be screened with a medical history and physical exam. They will have a psychiatric history with tests of thinking, judgment, and behavior. Blood and urine samples will be collected. Brain imaging scans will be performed to look at brain function. They may have a spinal tap to collect cerebrospinal fluid.
- Relatives will have a medical history and physical exam. They will also have a psychiatric history with tests of thinking, judgment, and behavior. Blood and urine samples will be collected. Brain imaging scans will be performed to look at brain function.
- A relative s exams may reveal a behavioral or other disorder. If so, he or she may re-enroll on the study as a person with the disorder.
|Condition or disease|
|Neurological Disorder Autism|
This is a diagnostic and treatment protocol designed to provide opportunities for identifying new clinical syndromes, providing cases for instruction and training, and permitting longitudinal assessments of a variety of childhood behavioral, psychiatric and developmental disorders. Disorders of particular interest are: autism, disorders of social cognition and other neurodevelopmental disorders; childhood psychiatric disorders and particularly those with acute symptom onset; and unique clinical presentations of pediatric behavioral syndromes, such as those associated with genetic disorders or those with a unique family history.
The primary objective of this protocol is to evaluate a variety of behavioral, neuropsychiatric and neurodevelopmental conditions. Assessing and treating participants will allow the PDN clinicians to maintain their clinical expertise and will provide opportunities for training. Further, the protocol will allow PDN investigators to gain additional knowledge about the course of various childhood behavioral syndromes and their response to standard therapies. The information obtained is expected to generate questions to be answered and hypotheses to be tested in future protocols. In some cases, blood, cerebrospinal fluid or other biologic samples (including urine, saliva and cheek swabs) obtained for clinical studies will be stored for future laboratory studies.
The number of participants to be enrolled will be set at 3,500 participants to permit inclusion of up to 1,000 probands (children, adolescents and adults) and their relatives (n = 2,500 to include key 2nd and 3rd degree relatives, as well as 1st degree relatives).
This is a natural history, treatment and training protocol. The cross-sectional portion of this study will include in-depth medical and laboratory assessments to evaluate the relationship of biological abnormalities with neuropsychiatric symptomatology. Family members will be studied to elucidate the nature of any genetic abnormalities observed in the probands. Clinically useful information (performed in a CLIA certified lab) will be shared with all participants. Standard therapeutic interventions may be utilized to evaluate their effects in well-characterized participants with unique clinical presentations. Participants also may be asked to return to NIH for periodic follow-up assessments, in order to facilitate the longitudinal assessment of natural and treated courses of illness as a means of better understanding their progression and pathophysiology.
No formal outcomes will be measured; however the clinical assessments of enrolled participants may be used to evaluate correlates of clinical symptomatology and response to standard therapeutic interventions. In addition, DNA samples may be obtained from participants and their relatives, in order to identify or verify causative genetic abnormalities in order to establish pathogenic mechanisms and genotype-phenotype correlations.
|Study Type :||Observational|
|Estimated Enrollment :||3500 participants|
|Official Title:||Diagnosis and Treatment of Childhood-onset Behavioral Disorders, Neuropsychiatric Disorders and Neurodevelopmental Disorders|
|Study Start Date :||January 26, 2013|
|Estimated Primary Completion Date :||July 6, 2020|
|Estimated Study Completion Date :||July 6, 2020|
- Gain knowledge about the course of specific neurodevelopmental and neuropsychiatric disorders in order to better characterize the natural history of such diseases, which can be used to generate hypotheses for future protocols [ Time Frame: 4 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01778504
|Contact: Susan E Swedo, M.D.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 email@example.com|
|Principal Investigator:||Susan E Swedo, M.D.||National Institute of Mental Health (NIMH)|