Efficacy, Safety, and Tolerability of Ambien (Zolpidem) in the Treatment of Children Ages 6 to 17 With Attention Deficit Hyperactivity Disorder (ADHD)-Associated Insomnia (Zolkids)
This study has been completed.
Sponsor:
Sanofi
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00318448
First received: March 14, 2006
Last updated: April 6, 2009
Last verified: April 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Attention Deficit Hyperactivity Disorder |
Drug: Zolpidem (SL800750) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Efficacy, Safety and Tolerability of Zolpidem in the Treatment of Children Aged 6 to 17 Years With ADHD-Associated Insomnia. A Multicentre, Randomized, Double-Blind, Placebo-Controlled Study |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Latency to persistent sleep (LPS) measured by polysomnography
Secondary Outcome Measures:
- 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
- PE, lab
| Enrollment: | 201 |
| Study Start Date: | April 2006 |
| Study Completion Date: | August 2006 |
| Primary Completion Date: | August 2006 (Final data collection date for primary outcome measure) |
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 period
Subjects will have a polysomnography in a sleep lab two times during the study (at baseline and between visit 4-5) and also be required to wear an actigraphy monitoring tool. There will be several questionnaires completed throughout the study: CGI-child, CGI-parent/legal guardian, ADHD Rating Scale-IV, and the Pediatric Daytime Sleepiness Scale.
Eligibility| Ages Eligible for Study: | 6 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00318448
Locations
| United States, New Jersey | |
| Sanofi-Aventis Administrative Office | |
| Bridgewater, New Jersey, United States, 08807 | |
| Canada | |
| Sanofi-Aventis Administrative Office | |
| Laval, Canada | |
Sponsors and Collaborators
Sanofi
Investigators
| Study Director: | ICD CSD | Sanofi |
More Information
No publications provided by Sanofi
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | ICD Study Director, sanofi-aventis |
| ClinicalTrials.gov Identifier: | NCT00318448 History of Changes |
| Other Study ID Numbers: | EFC6820 |
| Study First Received: | March 14, 2006 |
| Last Updated: | April 6, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Sanofi:
|
Child Psychology Pediatric Psychology Insomnia Sleeplessness |
Additional relevant MeSH terms:
|
Attention Deficit Disorder with Hyperactivity Hyperkinesis Attention Deficit and Disruptive Behavior Disorders Mental Disorders Diagnosed in Childhood Mental Disorders Dyskinesias Neurologic Manifestations Nervous System Diseases Signs and Symptoms Zolpidem Hypnotics and Sedatives |
Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses GABA-A Receptor Agonists GABA Agonists GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013