RecruitingNCT00271622

The Neurodevelopmental and Behavioral Phenotyping Screening Protocol

Neurodevelopmental and Behavioral Phenotyping Screening Protocol

Sponsor

National Institute of Mental Health (NIMH)

Enrollment

5,000 participants

Start Date

Feb 27, 2006

Study Type

OBSERVATIONAL

Conditions

Autism Neurologic Disorders Neurodegenerative Disease Neurobehavioral Manifestation

Summary

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

Min Age: 6 Weeks

Inclusion Criteria3

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).

Exclusion Criteria1

Lack of appropriate consent: For minor patients, consent must be obtained from all legal guardians/caretakers, including both parents in separated or divorced families where there is shared legal custody of the child. In such cases, both parents must consent to the child s participation in this protocol.

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