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Screening Protocol for Children and Adolescents With Attention Deficit Hyperactivity Disorder
This study is currently recruiting participants.
Verified by Massachusetts General Hospital, June 2008
Sponsored by: Massachusetts General Hospital
Information provided by: Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00592436
  Purpose

The objective of this protocol is to establish a comprehensive screening process to evaluate the eligibility of potential pediatric subjects for appropriate ADHD clinical research studies.


Condition
Pediatric ADHD

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder
U.S. FDA Resources
Study Type: Observational
Study Design: Case-Only, Prospective
Official Title: A Screening Protocol for Children and Adolescents With Attention Deficit Hyperactivity Disorder

Further study details as provided by Massachusetts General Hospital:

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 750
Study Start Date: March 2003
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts
1

Detailed Description:

The ADHD Clinical Research Program at Massachusetts General Hospital currently offers a range of protocols addressing different aspects of ADHD in children and adolescents. Although these protocols have received prior IRB approval, potential participants present with a widely varied set of complaints not always discernable in a telephone screening interview. This state of affairs often makes it difficult to ask subjects and their parents to sign a specific protocol's consent form without obtaining additional clinical information. Because of this, we are proposing that potential subjects and their parents undergo an in-depth clinical assessment that will allow them to be screened by a clinician for eligibility to a diverse clinical research program.

  Eligibility

Ages Eligible for Study:   5 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Children with symptoms of ADHD

Criteria

Inclusion Criteria:

  1. Males and females ages 5-18
  2. Family/guardian contacting the Clinical Research Program in Pediatric Psychopharmacology, with concerns regarding ADHD symptoms in his/her child

Exclusion Criteria:

  1. History of significant head trauma with loss of consciousness, organic brain disorders, seizures, or neurological intervention
  2. Any significant medical condition, in the judgment of the investigator
  3. Mental retardation
  4. Pregnancy or lactation
  5. Subjects with current, uncontrolled (within the past 3 months) illicit drug or alcohol dependence
  6. Sensory difficulties such as deafness or blindness
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00592436

Contacts
Contact: Meghan Kotarski, BS 617-503-1051 mkotarski@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Cambridge, Massachusetts, United States, 02138
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Joseph Biederman, MD MGH
  More Information

Related Info  This link exits the ClinicalTrials.gov site

Responsible Party: MGH ( Joseph Biederman, MD )
Study ID Numbers: 2003-P-000239
Study First Received: December 28, 2007
Last Updated: June 10, 2008
ClinicalTrials.gov Identifier: NCT00592436  
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
ADHD
pediatric
children

Study placed in the following topic categories:
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Mental Disorders Diagnosed in Childhood
Attention Deficit and Disruptive Behavior Disorders
Hyperkinesis

ClinicalTrials.gov processed this record on January 16, 2009