Effect of Atomoxetine on ADHD-Related Insomnia in Children and Adolescents

NCT00252278 | Unknown Phase 4

• 1 other identifier: 0120-05
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• mean sleep onset latency

• parent and child-reported evening settling difficulties

Secondary Outcomes (4)

• night wakings, sleep duration, and sleep efficiency

• daytime sleepiness

• ADHD symptom improvement

• executive functions and functional outcomes/quality of life

Interventions

atomoxetine DRUG

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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:
• difficulty initiating or maintaining sleep that is viewed as a problem by the child or caregiver
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rhode Island Hospital: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Sleep Initiation and Maintenance Disorders

Interventions

Atomoxetine Hydrochloride

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals

Study Officials

• Judith Owens, MD, MPH

  Rhode Island Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gloria Velez, B.A.

CONTACT

401-444-3250; gvelez@lifespan.org

Juhee Lee, B.A.

CONTACT

401-444-8815; jlee3@lifespan.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 9, 2005
• First Posted: November 11, 2005
• Study Start: November 1, 2005
• Last Updated: July 7, 2006

Record last verified: 2005-11

Locations

US (1)