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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00252278
Other study ID # 0120-05
Secondary ID
Status Recruiting
Phase Phase 4
First received November 9, 2005
Last updated July 5, 2006
Start date November 2005

Study information

Verified date November 2005
Source Rhode Island Hospital
Contact Gloria Velez, B.A.
Phone 401-444-3250
Email gvelez@lifespan.org
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Children and adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD) very commonly experience difficulty in initiating and maintaining sleep. Studies have shown that daytime sleepiness resulting from insufficient sleep can affect attention and learning. Therefore, treating insomnia in children with ADHD may not only improve sleep, but it could potentially improve ADHD symptoms as well.

The main purpose of this study is to examine the effects of atomoxetine on ADHD-related insomnia. Atomoxetine (Strattera®) is a non-stimulant drug used to treat ADHD symptoms in both children and adults, and there is evidence that it may also have a positive effect on sleep in children with ADHD. During the study, participants will receive either atomoxetine or placebo for a period of four weeks. We expect that the effects of atomoxetine on sleep will differ from those of placebo, with atomoxetine having a greater effect on improving sleep difficulties.


Recruitment information / eligibility

Status Recruiting
Enrollment 36
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 6 Years to 17 Years
Eligibility Inclusion Criteria:

- Boy or girl aged 6-17 years, inclusive, and English-speaking

- Meet the DSM-IV criteria for Attention-Deficit/Hyperactivity Disorder

- Have sleep initiation defined by:

1. difficulty initiating or maintaining sleep that is viewed as a problem by the child or caregiver

2. sleep onset delay that is not exclusively related to direct or rebound effects of psychostimulant treatment

- Have a parent or legal guardian willing to participate in the study

Exclusion Criteria:

- Have any other primary sleep disorder(s) (e.g. obstructive sleep apnea or periodic limb movement disorder)

- Have a history of significant chronic medical (e.g. diabetes, severe asthma) or psychiatric (e.g. depression) illness

- Have a history of chronic use of sedating (e.g. antihistamines) or alertness enhancing (e.g. caffeine) medications

- Have a history of failure to respond to an adequate (defined as appropriate dose and adequate duration of therapy) previous trial with atomoxetine

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms

  • Attention Deficit Disorder with Hyperactivity
  • Attention-Deficit/Hyperactivity Disorder (ADHD)
  • Insomnia

Intervention

Drug:
atomoxetine


Locations

Country Name City State
United States Rhode Island Hospital Providence Rhode Island

Sponsors (2)

Lead Sponsor Collaborator
Rhode Island Hospital Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary mean sleep onset latency
Primary parent and child-reported evening settling difficulties
Secondary night wakings, sleep duration, and sleep efficiency
Secondary daytime sleepiness
Secondary ADHD symptom improvement
Secondary executive functions and functional outcomes/quality of life
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