Study of the Effect of Individualizing Daytrana Wear-times on Sleep in Children 6-12 Years Old With Attention Deficit Hyperactivity Disorder (ADHD) - Full Text View

Study of the Effect of Individualizing Daytrana Wear-times on Sleep in Children 6-12 Years Old With Attention Deficit Hyperactivity Disorder (ADHD) (Daytsleep)

The recruitment status of this study is unknown because the information has not been verified recently.

Verified October 2009 by Cox Health Systems. Recruitment status was Not yet recruiting

First Received on September 30, 2009. Last Updated on October 8, 2009 History of Changes

Sponsor:	Cox Health Systems
Information provided by:	Cox Health Systems
ClinicalTrials.gov Identifier:	NCT00989950

Purpose

Methylphenidate may improve sleep in children with ADHD. By leaving Daytrana (methylphenidate) patch for a longer time then 9 hours, many children report short sleep latencies and better quality of sleep.

Condition	Intervention
Attention Deficit Hyperactivity Disorder Insomnia	Drug: methylphenidate transdermal system

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Open Label Study of the Effect of Individualizing Daytrana Wear-times on Sleep in Children 6-12 Years Old With ADHD

Resource links provided by NLM:

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder

Drug Information available for: Methylphenidate Methylphenidate hydrochloride

U.S. FDA Resources

Further study details as provided by Cox Health Systems:

Primary Outcome Measures:

The primary outcome is that longer patch wear times will lead to decreased sleep latency. [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	December 2009
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Daytrana	Drug: methylphenidate transdermal system Daytrana patch 10mg, 15mg, 20mg, 30mg administered once daily for 9hr, 10hr, 11hr and 12 hr wear. Other Names: Daytrana methylphenidate transdermal system

Detailed Description:

Once the optimal dose of Daytrana that controlled the ADHD symptoms is established. The patch will be removed 1, 2, and 3 hours before bed time in a random fashion, at weekly intervals, and parents will keep a sleep diary.

50 patients will be enrolled in order to obtain statistical significance.

Eligibility

Ages Eligible for Study:	6 Years to 12 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

ADHD without significant comorbidity

Exclusion Criteria:

Cardiac disorder
Hypertension
Thyroid disease
Glaucoma
History of sudden death, motor tics and/or Tourette's syndrome
Hypersensitivity to methylphenidate

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00989950

Contacts

Contact: Arie Ashkenasi, MD

417-269-1010

arie.ashkenasi@coxhealth.com

Locations

United States, Missouri
Pediatric Neurology of the Ozarks	Not yet recruiting
Springfield, Missouri, United States, 65807
Contact: angie randall 417-269-1010 angie.randall@coxhealth.com
Principal Investigator: arie ashkenasi, MD

Sponsors and Collaborators

Cox Health Systems

Investigators

Principal Investigator:

arie ashkenasi

pediatric neurology of the ozarks

More Information

No publications provided

Responsible Party:	arie ashkenasi MD., pediatric neurology of the ozarks
ClinicalTrials.gov Identifier:	NCT00989950 History of Changes
Other Study ID Numbers:	cox002, shire IND#54,732
Study First Received:	September 30, 2009
Last Updated:	October 8, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Cox Health Systems:

daytrana
sleep latency
adhd rating scales
ADHD

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
Methylphenidate

Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012