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Screening Protocol for Adults With ADHD

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Joseph Biederman, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00592254
First received: December 28, 2007
Last updated: November 5, 2014
Last verified: November 2014
  Purpose

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


Condition
ADHD

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Screening Protocol for Adults With Attention Deficit Hyperactivity Disorder

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Screening Protocol [ Time Frame: Sreening ] [ Designated as safety issue: No ]
    This study is a prescreening for possible entry into other studies


Estimated Enrollment: 3000
Study Start Date: December 2002
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)

Detailed Description:

To address the needs of the large number of adults who contact the Adult ADHD Program at Massachusetts General Hospital annually, we have sought approval for several research studies aimed at evaluating critical components of the needs of this population. Potential participants for those studies 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 to sign a specific protocol's consent form without obtaining additional clinical information. Because of this, we have potential subjects consent to undergo an in-depth clinical assessment that will allow them to be screened by a clinician for eligibility to a diverse clinical research program available to them.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adults with symptoms of ADHD

Criteria

Inclusion Criteria:

  1. Males and females ages 18-65
  2. Subjects must have a DSM-IV diagnosis of ADHD, as determined by a clinical evaluation based on DSM-IV criteria

Exclusion Criteria:

  1. History of head trauma with loss of consciousness, organic brain disorders, seizures, or neurosurgical intervention.
  2. Any significant medical condition, in the judgment of the investigator
  3. Mental retardation
  4. Pregnancy of lactation
  5. Subjects with a known recent history (within the past 6 months) of illicit drug or alcohol dependence
  6. Sensory difficulties such as deafness or blindness
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00592254

Contacts
Contact: Leah Feinberg, BS 617-726-4651 lkfeinberg@mgh.harvard.edu

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Joseph Biederman, MD Massachusetts General Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Joseph Biederman, MD, Chief, Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00592254     History of Changes
Other Study ID Numbers: 2002-P-001856
Study First Received: December 28, 2007
Last Updated: November 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
ADHD
Adults

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders
Mental Disorders Diagnosed in Childhood

ClinicalTrials.gov processed this record on November 25, 2014