The Effect of a Once Daily Dose of Atomoxetine (ATX) on ADHD-Related Insomnia in Children and Adolescents

NCT00566371 | Completed Phase 4

• 2 other identifiers: 701-13150120-05
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a single site, double-blind, randomized, placebo-controlled parallel group design. this study is designed to directly examine the efficacy of a single daily dose of atomoxetine taken in the morning in alleviating sleep initiation insomnia in children with ADHD. Primary outcome measures are sleep parameters, specifically mean sleep onset latency (time of onset to persistent sleep), as measured by actigraphy/sleep diary, and parent and child-reported evening settling difficulties, as measured on the evening subscale items of the parent and child versions of the DPREMB-R. Secondary outcome measures include: additional actigraphic sleep parameters (night wakings, sleep duration, and sleep efficiency), daytime sleepiness (Pediatric Daytime Sleepiness Scale, sleepiness visual analogue scale (VAS), and morning behaviors on the DPREMB-R); ADHD symptom improvement (ADHD-RS, parent version; provider-completed CGI); a neurocognitive measure of attention and impulsivity (CPT); executive functions (Brown ADD Scale for Children) and functional outcomes/quality of life (CHQ).

Conditions

Attention Deficit Hyperactivity Disorder; Insomnia

Keywords

attention deficit hyperactivity disorder; insomnia; atomoxetine

Outcome Measures

Primary Outcomes (1)

• Primary outcome measures are sleep parameters, specifically mean sleep onset latency as measured by actigraphy/sleep diary, and parent and child-reported evening settling difficulties.

  3 years

Secondary Outcomes (1)

• Secondary outcome measures include: additional actigraphic sleep parameters daytime sleepiness, ADHD symptom improvement; a neurocognitive measure of attention and impulsivity, executive functions, and functional outcomes/quality of life.

  3 years

Study Arms (2)

1

EXPERIMENTAL

Patients will then be randomized (at Visit 2) to receive either atomoxetine or placebo for 4 weeks (Treatment Period); study drug will be titrated individually according to tolerability and efficacy (measured by ADHD-RS and CGI-I) completed at Visits 3, 4, 5, and 6) at 7-10 day intervals to a maximum dose of 1.8 mg/kg.

Drug: atomoxetine

2

PLACEBO COMPARATOR

Patients will then be randomized (at Visit 2) to receive either atomoxetine or placebo for 4 weeks (Treatment Period); study drug will be titrated individually according to tolerability and efficacy (measured by ADHD-RS and CGI-I) completed at Visits 3, 4, 5, and 6) at 7-10 day intervals to a maximum dose of 1.8 mg/kg.

Drug: placebo

Interventions

atomoxetine DRUG

Patients will then be randomized (at Visit 2) to receive either atomoxetine or placebo for 4 weeks (Treatment Period); study drug will be titrated individually according to tolerability and efficacy (measured by ADHD-RS and CGI-I) completed at Visits 3, 4, 5, and 6) at 7-10 day intervals to a maximum dose of 1.8 mg/kg.

1

placebo DRUG

placebo

2

Eligibility Criteria

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

You may qualify if:

• Subjects are children aged 6 through 17 years with DSM-IV criteria-defined ADHD and sleep initiation insomnia.

Sponsors & Collaborators

• Rhode Island Hospital: lead

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

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

  Lifespan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 30, 2007
• First Posted: December 3, 2007
• Study Start: June 1, 2005
• Primary Completion: December 1, 2008
• Study Completion: June 1, 2009
• Last Updated: August 16, 2010

Record last verified: 2007-11

Locations

US (1)