Healthy Lifestyle in Adults With Attention Deficit Hyperactivity Disorder

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

Healthy Lifestyle in Adults With ADHD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00879320
• Other study ID #: 2008-P-002056
• Status: Completed
• Phase: N/A
• First received: April 9, 2009
• Last updated: October 21, 2013
• Start date: February 2009
• Est. completion date: May 2012

Study information

• Verified date: October 2013
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 253
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• ADHD
• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Cambridge	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Shire

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of ADHD and control subject health habits will be assessed by subject-rated questionnaires and health measures, such as vital signs and blood draw results.		1 time	Yes