Screening Protocol for Adults With ADHD

Mass General Brigham

Status: Unknown

Conditions: ADHD

Study type: Observational

Funder types: Other

Identifiers

NCT00592254

2002-P-001856

Details and patient eligibility

About

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

Full 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.

Enrollment: 3,000 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

3,000 participants in 1 patient group

A