Healthy Lifestyle in Adults With Attention Deficit Hyperactivity Disorder

NCT ID: NCT00879320

Last Updated: 2013-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

253 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-02-28

Study Completion Date

2012-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to understand the relationship between ADHD and the overall health of someone with ADHD. People who have ADHD have trouble paying attention, concentrating, organizing, and planning. They may have trouble in school, at work, and at home. The investigators are interested in finding out whether these difficulties have had any influence in the past, current, or future health problems of someone with ADHD. About 100 people with ADHD and 100 people without ADHD will take part in this research study, all through Massachusetts General Hospital (MGH).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

ADHD Attention Deficit Hyperactivity Disorder

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

ADHD health healthy lifestyle

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Adults with ADHD

No interventions assigned to this group

2

Healthy adults without ADHD

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

ADHD Subjects

1. Signed written informed consent to participate in the study.
2. Age: 18 - 60 (inclusive).
3. Current diagnosis of DSM-IV ADHD by structured interview. Late age of onset acceptable for participation provided ADHD symptoms meet full criteria currently.

Control Subjects

1. Signed written informed consent to participate in the study.
2. Age: 18 - 60 (inclusive).
3. Subjects must have \<3 symptoms in each domain (Inattention and Hyperactive/Impulsive) and \<5 total symptoms in both domains on the DSM-IVADHD module of the structured interview.

Exclusion Criteria

1. Diagnosis of any psychotic disorder or Autism.
2. Mental impairment as evidenced by a Full Scale I.Q. less than 80.
3. Major sensorimotor handicaps such as deafness or blindness.
4. Subject currently taking antipsychotic medication or mood stabilizers.
5. Inadequate command of the English language.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Shire

INDUSTRY

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Thomas J. Spencer, MD

Associate Chief, Clinical and Research Program, Pediatric Psychopharmacology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Thomas Spencer, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Massachusetts General Hospital

Cambridge, Massachusetts, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2008-P-002056

Identifier Type: -

Identifier Source: org_study_id