Screening for Studies on Autism Spectrum Disorders - NCT00271622-20892 (Clinical Trial 135307)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy135307.aspx
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| City: |
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Bethesda |
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State:
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MD |
| Zip Code: |
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20892 |
| Conditions: |
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Autism Spectrum Disorders |
| Purpose: |
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This study will screen children and adolescents (and their parents) to determine the child's
eligibility for participation in NIMH research studies on autism spectrum disorders, such as
autism and Rett's Disorder.
Screening evaluations include some or all of the following procedures:
Parent interview
Parent and child evaluations including:
- Diagnostic interview
- Developmental or cognitive testing
- Ratings of psychiatric and medical symptoms
- Neuropsychological testing
- Personal, social an family history
Child physical examination and possible blood draw
Children who are determined eligible for a current NIMH research protocol are invited to
participate.
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| Study summary: |
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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 will help determine if the participant meets criteria
for participation in research protocols of the Pediatric and Developmental Neuropscience
Branch (PDN) at the National Institute of Mental Health (NIMH) and other collaborative
investigations. This protocol will be the entry point for all PDN 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 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. Upon conclusion of the screening process, subjects seeking
eligibility for PDN protocols will either be offered participation in a research protocol
and will sign the appropriate informed consent, or will be considered not appropriate for
participation in research and will be discharged from the protocol. |
| Criteria: |
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- INCLUSION CRITERIA:
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, pregnancy testing, and urine drug screen for the presence of
psychoactive drugs and drugs of abuse, as determined on a subject-to-subject basis).
EXCLUSION CRITERIA:
Presence of impairing medical or psychiatric illness
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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| Study is available at: |
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National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, MD 20892
United States
Primary Contact:
Patient Recruitment and Public Liaison Office
Email: prpl@mail.cc.nih.gov
Phone: (800) 411-1222 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 15, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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