The Neurodevelopmental and Behavioral Phenotyping Screening Protocol
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6+
SponsorNational Institute of Mental Health (NIMH)
About this trial
The purpose of this protocol is to allow for the careful evaluation of healthy volunteers and individuals with risk for psychiatric disorders or neurodevelopmental disorders, such as autism spectrum disorder for specific protocols at NIH.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Subjects must be at least 6 weeks of age.
Subjects or their parents must be competent to comprehend the purpose of the screening process and to provide written informed consent. Parents/guardians will sign the consent form, and both minors and adults (depending on results of capacity assessment) will be asked to assent only if it is determined that they understand their role in the study.
Subjects must be willing to undergo an evaluation which may include a psychiatric interview; and medical, neurological, and laboratory examinations (as appropriate, such as renal and liver function tests, serum electrolytes, urinalysis, blood levels of psychotropic drugs, and urine drug screen for the presence of psychoactive drugs and drugs of abuse, as determined on a subject-to-subject basis).
Disqualifiers
None
Trial population
The population consists of healthy volunteers and individuals with risk for psychiatric disorders or neurodevelopmental disorders, such as autism spectrum disorders.
Trial design
Design model
Other
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
5,000 Participants
are grouped into 2 trial groupsGroup A: healthy volunteers
Group B: individuals at risk
Trial outcomes
Primary outcomes
1
Screening evaluations such as a psychiatric interview; a diagnostic interview; developmental and/or cognitive testing; ratings of other psychiatric symptoms
Screening evaluations such as a psychiatric interview; a diagnostic interview; developmental and/or cognitive testing; ratings of other psychiatric symptoms
Time frame
OngoingSponsors and contacts
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Source ClinicalTrials.gov