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Study of the Effect of Individualizing Daytrana Wear-times on Sleep in Children With ADHD

NCT ID: NCT00989950

Last Updated: 2012-07-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2011-02-28

Brief Summary

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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.

Detailed Description

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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.

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

Conditions

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Attention Deficit Hyperactivity Disorder INSOMNIA

Keywords

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daytrana sleep latency adhd rating scales ADHD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Daytrana 9 hr wear

Group Type EXPERIMENTAL

Daytrana

Intervention Type DRUG

Daytrana patch 10-30 mg administered once daily for 9hr

Daytrana 10 hr wear

Group Type EXPERIMENTAL

Daytrana

Intervention Type DRUG

Daytrana 10-30 mg worn once daily for 10 hr wear

Daytrana 11 hr wear

Group Type EXPERIMENTAL

Daytrana

Intervention Type DRUG

Daytrana 10-30 mg worn once daily for 11 hr

Daytrana 12 hr wear

Group Type EXPERIMENTAL

Daytrana

Intervention Type DRUG

Daytrana 10-30 mg worn once daily for 12 hrs

Interventions

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Daytrana

Daytrana patch 10-30 mg administered once daily for 9hr

Intervention Type DRUG

Daytrana

Daytrana 10-30 mg worn once daily for 10 hr wear

Intervention Type DRUG

Daytrana

Daytrana 10-30 mg worn once daily for 11 hr

Intervention Type DRUG

Daytrana

Daytrana 10-30 mg worn once daily for 12 hrs

Intervention Type DRUG

Other Intervention Names

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methylphenidate transdermal system methylphenidate transdermal system methylphenidate transdermal system

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cox Health Systems

OTHER

Sponsor Role lead

Responsible Party

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Arie Ashkenasi, MD

Staff Neurologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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arie ashkenasi

Role: PRINCIPAL_INVESTIGATOR

pediatric neurology of the ozarks

Locations

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Pediatric Neurology of the Ozarks

Springfield, Missouri, United States

Site Status

Countries

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United States

References

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Ashkenasi A. Effect of transdermal methylphenidate wear times on sleep in children with attention deficit hyperactivity disorder. Pediatr Neurol. 2011 Dec;45(6):381-6. doi: 10.1016/j.pediatrneurol.2011.09.003.

Reference Type RESULT
PMID: 22115000 (View on PubMed)

Other Identifiers

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shire IND#54,732

Identifier Type: OTHER

Identifier Source: secondary_id

cox002

Identifier Type: -

Identifier Source: org_study_id