Screening Protocol for Adults With ADHD

• ClinicalTrials.gov Identifier: NCT00592254
• Recruitment Status: Unknown
• First Posted: January 14, 2008
• Last Update Posted: January 18, 2022
• Sponsor: Massachusetts General Hospital
• Information provided by (Responsible Party): Joseph Biederman, MD, Massachusetts General Hospital

Tracking Information

• First Submitted Date: December 28, 2007
• First Posted Date: January 14, 2008
• Last Update Posted Date: January 18, 2022
• Study Start Date: December 2002
• Estimated Primary Completion Date: December 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 21, 2013)

Screening Protocol [ Time Frame: Sreening ]

This study is a prescreening for possible entry into other studies

• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Screening Protocol for Adults With ADHD
• Official Title: A Screening Protocol for Adults With Attention Deficit Hyperactivity Disorder
• 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
• 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 Type: Observational
• Study Design: Observational Model: Case-Only; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Adults with symptoms of ADHD
• Condition: ADHD
• Intervention: Not Provided
• Study Groups/Cohorts: A
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: April 22, 2013): 3000
• Original Estimated Enrollment (submitted: December 28, 2007): 2000
• Estimated Study Completion Date: December 2023
• Estimated Primary Completion Date: December 2023 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00592254
• Other Study ID Numbers: 2002-P-001856
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Joseph Biederman, MD, Massachusetts General Hospital
• Original Responsible Party: Joseph Biederman, MD, MGH
• Current Study Sponsor: Massachusetts General Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Joseph Biederman, MD; Massachusetts General Hospital

• PRS Account: Massachusetts General Hospital
• Verification Date: January 2022