NCT00318448

Brief Summary

There has been an increased interest in the association between ADHD and sleep disorders over the past years. A high incidence of sleep disturbance, ranging from 10% to 70%, has been identified in ADHD children regardless of whether or not they are receiving stimulant therapy. This study will assess the safety and efficacy of zolpidem in children with ADHD associated insomnia.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
201

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2006

Shorter than P25 for phase_3

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2006

Completed
18 days until next milestone

Study Start

First participant enrolled

April 1, 2006

Completed
25 days until next milestone

First Posted

Study publicly available on registry

April 26, 2006

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

April 7, 2009

Status Verified

April 1, 2009

Enrollment Period

4 months

First QC Date

March 14, 2006

Last Update Submit

April 6, 2009

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

Child PsychologyPediatric PsychologyInsomniaSleeplessness

Outcome Measures

Primary Outcomes (1)

  • Latency to persistent sleep (LPS) measured by polysomnography

Secondary Outcomes (6)

  • Clinical Global Impression (CGI) Severity and Global Improvement item scores (from child and parent/legal guardian scales)

  • Actigraphy measures of sleep characteristics

  • ADHD Rating Scale-IV

  • School tardiness/Attendance Reports

  • Adverse events

  • +1 more secondary outcomes

Interventions

Zolpidem (SL800750)DRUG

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Male or female between the ages of 6 and 17 years, inclusive
  • Children with diagnosed ADHD (as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision \[DSM-IV-TR\] criteria)
  • Complaint of childhood insomnia as defined by repeated difficulty with sleep initiation or consolidation that occurs despite adequate age, appropriate time, and opportunity for sleep
  • The sleep disturbance must not be attributable to either the direct physiologic effect of drug abuse or misuse of a prescribed medication.
  • Subjects should be stabilized on all long-term therapy, including treatment of ADHD, for at least one month prior to study entry.
  • Subjects, if females of childbearing potential (as determined by the initiation of menses), must have confirmed negative pregnancy test prior to randomization and be using a recognized effective method of birth control (oral, implant, depot or transdermal oestroprogestatives, intrauterine device, double-barrier with spermicide). Abstinence is an acceptable method of birth control for this study.

You may not qualify if:

  • Mental retardation
  • Autistic spectrum disorder
  • A history of sleep apnea
  • A history of bipolar disorder, conduct disorder, major depression, or generalized anxiety disorder (not obsessive compulsive disorder), as determined by clinical interview and DSM-IV-TR criteria
  • Current history of substance abuse/dependence
  • Known hypersensitivity to zolpidem or previous adverse experience with zolpidem
  • Pregnant or breast-feeding
  • Current use of hypnotics, antihistamines, melatonin, herbal products, or other sleep aids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, 08807, United States

Location

Sanofi-Aventis Administrative Office

Laval, Canada

Location

Related Publications (1)

  • Blumer JL, Findling RL, Shih WJ, Soubrane C, Reed MD. Controlled clinical trial of zolpidem for the treatment of insomnia associated with attention-deficit/ hyperactivity disorder in children 6 to 17 years of age. Pediatrics. 2009 May;123(5):e770-6. doi: 10.1542/peds.2008-2945.

    PMID: 19403468DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with HyperactivitySleep Initiation and Maintenance Disorders

Interventions

Zolpidem

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental DisordersSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • ICD CSD

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 14, 2006

First Posted

April 26, 2006

Study Start

April 1, 2006

Primary Completion

August 1, 2006

Study Completion

August 1, 2006

Last Updated

April 7, 2009

Record last verified: 2009-04

Locations

US(1)CA(1)