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| Sponsor: | University Health Network, Toronto |
|---|---|
| Collaborator: |
The Hospital for Sick Children |
| Information provided by: | University Health Network, Toronto |
| ClinicalTrials.gov Identifier: | NCT00152750 |
Purpose
In the present study, we examine the question “Will day-time aggression in children improve when their night-time sleep is treated with pharmacological intervention (i.e. clonidine)?” There is considerable anecdotal evidence that clonidine may provide an effective alternative to neuroleptics for treating aggression in children -- first by improving the overall quality of their sleep, and second by providing a safer and more readily tolerated medication with fewer side-effects and a greater probability of long-term compliance. This study uses a double blind placebo controlled design to gather scientific evidence that will help elucidate the mechanisms underlying this treatment effect and will help clarify the relationship between sleep disorders and aggression in children. Our results are expected to help physicians make informed treatment decisions regarding the use of clonidine to improve the quality of sleep and possibly treat problems with aggression in their pediatric patients
| Condition | Intervention | Phase |
|---|---|---|
|
Tourette's Syndrome Attention Deficit Hyperactivity Disorder |
Drug: APO-clonidine |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Aggressive Behaviour in Children With Tourette's Syndrome (TS) and Comorbid Attention Deficit Hyperactivity Disorder (ADHD) |
| Estimated Enrollment: | 32 |
| Study Start Date: | September 2006 |
| Estimated Study Completion Date: | October 2008 |
Background: Childhood sleep disturbance is pervasive, yet remains under-treated and one of the most poorly researched areas in pediatric psychopharmacology. Of particular concern is the growing evidence of an association between sleep disturbance and aggression in children. Childhood aggression is a serious public health problem and predicts adolescent delinquency, academic difficulties and truancy, and substance abuse. Children with Tourette’s syndrome (TS) and co-morbid attention deficit hyperactivity disorder (ADHD) will be studied in a trial of a common pharmacological treatment (clonidine) that is expected to improve sleep architecture and thereby clarify the relation between sleep disturbance and aggression.
Hypothesis: Our main hypothesis is that improvement in children’s sleep will be associated with a reduction in their aggression and an increase in their daily function.
Method: A double-blind placebo controlled trial with 32 subjects (aged 9-14 years) with diagnoses of TS & co-morbid ADHD. Subjects will undergo a mental health assessment, ECG, laboratory testing and 2-night polysomnography (sleep study) at baseline. Subjects will then be randomized to a treatment (clonidine) or placebo group for an 8-week trial. Clonidine will be titrated and subjects monitored weekly. A second 2-night sleep study and mental health assessment will occur at trial end.
Expected results: We expect an improvement in the initial onset, duration and overall sleep quality in the treatment group (clonidine), with a resulting decrease in daytime aggression and increase in daily overall level of functioning; sleep and aggression in the placebo group are not expected to improve.
Eligibility| Ages Eligible for Study: | 9 Years to 14 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
*Evidence of Pervasive Developmental Disorder, known seizure disorder, history of severe head trauma, post-traumatic stress disorder, depression, known organic basis for a sleep disorder and/or an estimated Full Scale Intellectual Quotient below 85
Contacts and Locations| Contact: Robyn J Stephens, PhD. C.Psych | 416-368-4896 ext 2260 | rstephens@youthdale.ca |
| Contact: Paul Sandor, MD, FRCPC | 416-603-5794 | paul.sandor@uhn.on.ca |
| Canada, Ontario | |
| Youthdale Treatment Centres | Recruiting |
| Toronto, Ontario, Canada, M5B 1T8 | |
| Contact: Robyn J Stephens, PhD. C.Psych 416-368-4896 ext 2874 rstephens@youthdale.ca | |
| Principal Investigator: Robyn J Stephens, PhD. CPsych | |
| Sub-Investigator: Paul Sandor, MD, FRCPC | |
| Sub-Investigator: Colin M Shapiro, MD, FRCPC | |
| Principal Investigator: | Robyn J Stephens, PhD.C.Psych. | Youthdale Treatment Centres |
More Information
| ClinicalTrials.gov Identifier: | NCT00152750 History of Changes |
| Other Study ID Numbers: | StephensClonidine2005, SickKids #XG05-032, REB 130/2004 |
| Study First Received: | September 7, 2005 |
| Last Updated: | February 27, 2007 |
| Health Authority: | Canada: Health Canada |
|
Tourette's Syndrome Attention Deficit Hyperactivity Disorder Children Sleep disorders Aggression |
|
Tourette Syndrome Attention Deficit Disorder with Hyperactivity Hyperkinesis Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Tic Disorders Movement Disorders Heredodegenerative Disorders, Nervous System Neurodegenerative Diseases Genetic Diseases, Inborn Mental Disorders Diagnosed in Childhood Mental Disorders Attention Deficit and Disruptive Behavior Disorders |
Dyskinesias Neurologic Manifestations Signs and Symptoms Clonidine Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Sympatholytics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists |
