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Healthy Lifestyle in Adults With Attention Deficit Hyperactivity Disorder

This study has been completed.
Sponsor:
Collaborator:
Shire Development LLC
Information provided by (Responsible Party):
Thomas J. Spencer, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00879320
First received: April 9, 2009
Last updated: June 20, 2012
Last verified: June 2012
History of Changes
  Purpose

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).


Condition
ADHD
Attention Deficit Hyperactivity Disorder

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Healthy Lifestyle in Adults With ADHD

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • 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 ]

Enrollment: 253
Study Start Date: February 2009
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Adults with ADHD
2
Healthy adults without ADHD

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00879320

Locations
United States, Massachusetts
Massachusetts General Hospital
Cambridge, Massachusetts, United States, 02138
Sponsors and Collaborators
Massachusetts General Hospital
Shire Development LLC
Investigators
Principal Investigator: Thomas Spencer, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Thomas J. Spencer, MD, Associate Chief, Clinical and Research Program, Pediatric Psychopharmacology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00879320     History of Changes
Other Study ID Numbers: 2008-P-002056
Study First Received: April 9, 2009
Last Updated: June 20, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
ADHD
health
healthy lifestyle

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
 Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013