NCT00879320

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
253

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 9, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 10, 2009

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

October 22, 2013

Status Verified

October 1, 2013

Enrollment Period

3.2 years

First QC Date

April 9, 2009

Last Update Submit

October 21, 2013

Conditions

Keywords

ADHDhealthhealthy lifestyle

Outcome Measures

Primary Outcomes (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.

    1 time

Study Arms (2)

1

Adults with ADHD

2

Healthy adults without ADHD

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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)

You may qualify if:

  • ADHD Subjects
  • Signed written informed consent to participate in the study.
  • Age: 18 - 60 (inclusive).
  • 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
  • Signed written informed consent to participate in the study.
  • Age: 18 - 60 (inclusive).
  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Cambridge, Massachusetts, 02138, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Thomas Spencer, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Chief, Clinical and Research Program, Pediatric Psychopharmacology

Study Record Dates

First Submitted

April 9, 2009

First Posted

April 10, 2009

Study Start

February 1, 2009

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

October 22, 2013

Record last verified: 2013-10

Locations