Status:
COMPLETED
Efficacy, Safety, and Tolerability of Ambien (Zolpidem) in the Treatment of Children Ages 6 to 17 With Attention Deficit Hyperactivity Disorder (ADHD)-Associated Insomnia
Lead Sponsor:
Sanofi
Conditions:
Attention Deficit Hyperactivity Disorder
Eligibility:
All Genders
6-17 years
Phase:
PHASE3
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 ADH...
Detailed Description
The study is being conducted in the United States. It consists of 3 segments: * Segment A: 2 to 21 day screening period * Segment B: 8-week double-blind treatment period * Segment C: 1-week follow-up...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2006
Estimated Enrollment :
201 Patients enrolled
Trial Details
Trial ID
NCT00318448
Start Date
April 1 2006
End Date
August 1 2006
Last Update
April 7 2009
Active Locations (2)
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1
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
2
Sanofi-Aventis Administrative Office
Laval, Canada