Screening Protocol for Adults With ADHD

• Conditions: ADHD

• Registration Number: NCT00592254
• Lead Sponsor: Massachusetts General Hospital

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 Timeline

• Study Start: 2002-12
• Study First Submitted: 2007-12-28
• Study First Submitted QC: 2007-12-28
• Study First Posted: 2008-01-14
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-14
• Last Update Posted: 2022-01-18
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Screening Protocol	Sreening	This study is a prescreening for possible entry into other studies

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States