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Protocol Details

Neurodevelopmental and Behavioral Phenotyping Screening Protocol

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

06-M-0065

Sponsoring Institute

National Institute of Mental Health (NIMH)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 6 wk
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

None

Keywords

Developmental Delay;
Pediatric;
Pervasive Developmental Disorder;
Early Development;
Healthy Control Subjects

Recruitment Keyword(s)

Autism Spectrum Disorders;
Pervasive Developmental Disorder;
Healthy Volunteer;
HV

Condition(s)

Neurologic Disorders;
Autism;
Neurodegenerative Disease;
Neurobehavioral Manifestation

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Mental Health

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.

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Eligibility

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.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Audrey E. Thurm, Ph.D.
National Institute of Mental Health (NIMH)
NIHBC 10 - CLINICAL CENTER BG RM 1C250
10 CENTER DR
BETHESDA MD 20892
(301) 496-6768
at191u@nih.gov

Margaret J. Pekar
National Institute of Mental Health (NIMH)
National Institutes of Health
Building 10
Room 1C250
10 Center Drive
Bethesda, Maryland 20892
(301) 435-7962
pekarm@mail.nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT00271622

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