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Healthy Lifestyle in Adults With Attention Deficit Hyperactivity Disorder

This study has been completed.
Sponsor:
Collaborator:
Shire
Information provided by (Responsible Party):
Thomas J. Spencer, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00879320
First received: April 9, 2009
Last updated: October 21, 2013
Last verified: October 2013

April 9, 2009
October 21, 2013
February 2009
May 2012   (final data collection date for primary outcome measure)
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. [ Time Frame: 1 time ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00879320 on ClinicalTrials.gov Archive Site
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Healthy Lifestyle in Adults With Attention Deficit Hyperactivity Disorder
Healthy Lifestyle in Adults With ADHD

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).

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Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
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Non-Probability Sample

Adults ages 18-55 who have ADHD (for ADHD group) Healthy adult volunteers ages 18-55 who do not have ADHD (control group)

  • ADHD
  • Attention Deficit Hyperactivity Disorder
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  • 1
    Adults with ADHD
  • 2
    Healthy adults without ADHD
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
253
May 2012
May 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00879320
2008-P-002056
No
Thomas J. Spencer, MD, Massachusetts General Hospital
Massachusetts General Hospital
Shire
Principal Investigator: Thomas Spencer, MD Massachusetts General Hospital
Massachusetts General Hospital
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP