The Neurodevelopmental and Behavioral Phenotyping Screening Protocol

National Institute of Mental Health (NIMH)5,000 enrolled

Overview

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 disorders. The evaluations may be used to determine if the participant meets criteria for participation in research protocols at the National Institute of Mental Health (NIMH) and other collaborative investigations. Since the entry criteria for these protocols vary, the screening evaluations will also vary. Behavioral evaluations will also be done through this protocol for individuals participating in IRB-approved protocols being conducted by collaborating scientists at NIH. The evaluations might include: a psychiatric interview; a diagnostic interview; developmental and/or cognitive testing; ratings of other psychiatric symptoms; neuropsychological testing; a medical history; a physical exam; blood; and a request for medical records. Parents of minors will be interviewed.

Study Type

OBSERVATIONAL

Enrollment

5,000

Conditions

Neurologic Disorders Autism Neurodegenerative Disease Neurobehavioral Manifestation

Eligibility

Sex: ALLMin age: 6 WeeksHealthy volunteers:

Medical Language ↔ Plain English

* INCLUSION CRITERIA: * 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 CRITERIA: -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.

Locations (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

RECRUITING

Outcomes

Primary Outcomes

Screening evaluations such as a psychiatric interview; a diagnostic interview; developmental and/or cognitive testing; ratings of other psychiatric symptoms

Time frame: Ongoing

Central Contacts

Margaret J Pekar

CONTACT

(301) 435-7962 pekarm@mail.nih.gov

Genalynne C Mooneyham, M.D.

CONTACT

(301) 435-6651 gena.mooneyham@nih.gov

Data from ClinicalTrials.gov

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