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Screening Protocol for Adults With ADHD

This study is currently recruiting participants.
Verified September 2017 by Joseph Biederman, MD, Massachusetts General Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT00592254
First Posted: January 14, 2008
Last Update Posted: September 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Joseph Biederman, MD, Massachusetts General Hospital
  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 Joseph Biederman, MD, Massachusetts General Hospital:

Primary Outcome Measures:
  • Screening Protocol [ Time Frame: Sreening ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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 or DSM-V diagnosis of ADHD, as determined by a clinical evaluation based on DSM-IV or DSM-V 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00592254


Contacts
Contact: Alexa Pulli, BS 617-726-4651 apulli@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:
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
First Submitted: December 28, 2007
First Posted: January 14, 2008
Last Update Posted: September 7, 2017
Last Verified: September 2017

Keywords provided by Joseph Biederman, MD, Massachusetts General Hospital:
ADHD
Adults

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders