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Screening Protocol for Adults With ADHD

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ClinicalTrials.gov Identifier: NCT00592254
Recruitment Status : Unknown
Verified January 2022 by Joseph Biederman, MD, Massachusetts General Hospital.
Recruitment status was:  Active, not recruiting
First Posted : January 14, 2008
Last Update Posted : January 18, 2022
Sponsor:
Information provided by (Responsible Party):
Joseph Biederman, MD, Massachusetts General Hospital

Study Description
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Brief Summary:
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 or disease
ADHD

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.
Study Design
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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Screening Protocol for Adults With Attention Deficit Hyperactivity Disorder
Study Start Date : December 2002
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
A


Outcome Measures
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Primary Outcome Measures :
  1. Screening Protocol [ Time Frame: Sreening ]
    This study is a prescreening for possible entry into other studies


Eligibility Criteria
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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 18-55
  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
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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


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

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Responsible Party: Joseph Biederman, MD, Chief, Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00592254    
Other Study ID Numbers: 2002-P-001856
First Posted: January 14, 2008    Key Record Dates
Last Update Posted: January 18, 2022
Last Verified: January 2022
Keywords provided by Joseph Biederman, MD, Massachusetts General Hospital:
ADHD
Adults