Recruiting

Atomoxetine

Sponsor:

Rhode Island Hospital

Code:

NCT00252278

Conditions

Attention-Deficit/Hyperactivity Disorder (ADHD)

Insomnia

Eligibility Criteria

Sex: All

Age: 6 - 17

Healthy Volunteers: Not accepted

Interventions

atomoxetine

Study Details

Brief 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.

Conditions

Attention-Deficit/Hyperactivity Disorder (ADHD)

Insomnia

Study ID

NCT00252278

Start date

Nov, 2005

Status verified date

Nov, 2005

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 17

Healthy Volunteers: Not accepted

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

Enrollment

36 participants

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

atomoxetine

Primary outcome measure

  • mean sleep onset latency [ Time Frame: undefined ]
  • parent and child-reported evening settling difficulties [ Time Frame: undefined ]

Central Contacts and Locations

Central contacts

Gloria Velez, B.A.

401-444-3250gvelez@lifespan.org

Juhee Lee, B.A.

401-444-8815jlee3@lifespan.org

Locations

Rhode Island Hospital

Recruiting

Providence, Rhode Island, United States, 02903

More Information

Sponsor

Rhode Island Hospital

Last update posted

Jul 7, 2006

Last verified

Nov, 2005

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rhode Island Hospital on 2006-07-07.