The Neurodevelopmental and Behavioral Phenotyping Screening Protocol

Autism Clinical Trial

Official title:

Neurodevelopmental and Behavioral Phenotyping Screening Protocol

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00271622
• Other study ID #: 060065
• Secondary ID: 06-M-0065
• Status: Recruiting
• Start date: February 27, 2006

Study information

• Verified date: May 17, 2024
• Source: National Institutes of Health Clinical Center (CC)
• Contact: Margaret J Pekar
• Phone: (301) 435-7962
• Email: pekarm[@]mail.nih.gov
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The purpose of this protocol is to allow for the careful evaluation of healthy volunteers and individuals with 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 specific research protocols at the National Institute of Mental Health (NIMH) and other collaborative investigations.Since the entry criteria for these protocols vary, inclusion criteria and 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 in 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Weeks and older

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.

Related Conditions & MeSH terms

• Autism
• Nervous System Diseases
• Neurobehavioral Manifestation
• Neurobehavioral Manifestations
• Neurodegenerative Disease
• Neurodegenerative Diseases
• Neurologic Disorders

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Ongoing

External Links

•   NIH Clinical Center Detailed Web Page