Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Healthy Lifestyle in Adults With Attention Deficit Hyperactivity Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00879320
Recruitment Status : Completed
First Posted : April 10, 2009
Last Update Posted : October 22, 2013
Sponsor:
Collaborator:
Shire
Information provided by (Responsible Party):
Thomas J. Spencer, MD, Massachusetts General Hospital

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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).

Condition or disease
ADHD Attention Deficit Hyperactivity Disorder

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 253 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Healthy Lifestyle in Adults With ADHD
Study Start Date : February 2009
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
1
Adults with ADHD
2
Healthy adults without ADHD


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00879320


Locations
Layout table for location information
United States, Massachusetts
Massachusetts General Hospital
Cambridge, Massachusetts, United States, 02138
Sponsors and Collaborators
Massachusetts General Hospital
Shire
Investigators
Layout table for investigator information
Principal Investigator: Thomas Spencer, MD Massachusetts General Hospital
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Thomas J. Spencer, MD, Associate Chief, Clinical and Research Program, Pediatric Psychopharmacology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00879320    
Other Study ID Numbers: 2008-P-002056
First Posted: April 10, 2009    Key Record Dates
Last Update Posted: October 22, 2013
Last Verified: October 2013
Keywords provided by Thomas J. Spencer, MD, Massachusetts General Hospital:
ADHD
health
healthy lifestyle
Additional relevant MeSH terms:
Layout table for MeSH terms
Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
 Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases