Screening Protocol for Adults With ADHD

A Screening Protocol for Adults With Attention Deficit Hyperactivity Disorder

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

Study Overview

• Status: Active, not recruiting
• Conditions: 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 Type: Observational
• Enrollment (Anticipated): 3000

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults with symptoms of ADHD

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
A

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Screening Protocol	This study is a prescreening for possible entry into other studies	Sreening

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: December 1, 2002
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: December 28, 2007
• First Submitted That Met QC Criteria: December 28, 2007
• First Posted (Estimate): January 14, 2008

Study Record Updates

• Last Update Posted (Actual): January 18, 2022
• Last Update Submitted That Met QC Criteria: January 14, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: ADHD; Adults
• Other Study ID Numbers: 2002-P-001856