Screening Protocol for Adults With ADHD
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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 |
| 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 |
Adults with symptoms of ADHD
Inclusion Criteria:
- Males and females ages 18-65
- Subjects must have a DSM-IV diagnosis of ADHD, as determined by a clinical evaluation based on DSM-IV criteria
Exclusion Criteria:
- History of head trauma with loss of consciousness, organic brain disorders, seizures, or neurosurgical intervention.
- Any significant medical condition, in the judgment of the investigator
- Mental retardation
- Pregnancy of lactation
- Subjects with a known recent history (within the past 6 months) of illicit drug or alcohol dependence
- Sensory difficulties such as deafness or blindness
Contacts and Locations| Contact: Katie McDermott, BS | 617-726-4651 | kmmcdermott@partners.org |
| United States, Massachusetts | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| 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: | April 22, 2013 |
| 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 Diagnosed in Childhood Mental Disorders |
ClinicalTrials.gov processed this record on June 18, 2013