Healthy Lifestyle in Adults With Attention Deficit Hypera... | NCT00879320

Studies
Healthy Lifestyle in Adults With Attention Deficit Hyperactivity Disorder

NCT00879320

Sponsor

Massachusetts General Hospital

Status

Completed

Last Update Posted

Oct 22, 2013Estimated

Enrollment

253Actual

Phase

Not provided

Conditions

ADHD
Attention Deficit Hyperactivity Disorder

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2009

Primary Completion Date

May 2012Actual

Completion Date

May 2012Actual

First Submitted Date

Apr 9, 2009

First Submission Date that Met QC Criteria

Apr 9, 2009

First Posted Date

Apr 10, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 21, 2013

Last Update Posted Date

Oct 22, 2013Estimated

Name	Class
Shire	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

253Actual

Label	Type	Description	Intervention Names
1		Adults with ADHD
2		Healthy adults without ADHD

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

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)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Thomas Spencer, MD	Massachusetts General Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Massachusetts General Hospital		Cambridge	Massachusetts	02138	United States

Condition Browse Module

MeSH Terms

ID	Term
D001289	Attention Deficit Disorder with Hyperactivity

Ancestor Terms

ID	Term
D019958	Attention Deficit and Disruptive Behavior Disorders
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided