Study of Clonidine on Sleep Architecture in Children With Tourette's Syndrome (TS) and Comorbid ADHD
|ClinicalTrials.gov Identifier: NCT00152750|
Recruitment Status : Unknown
Verified October 2006 by University Health Network, Toronto.
Recruitment status was: Recruiting
First Posted : September 9, 2005
Last Update Posted : February 28, 2007
|Condition or disease||Intervention/treatment||Phase|
|Tourette's Syndrome Attention Deficit Hyperactivity Disorder||Drug: APO-clonidine||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Aggressive Behaviour in Children With Tourette's Syndrome (TS) and Comorbid Attention Deficit Hyperactivity Disorder (ADHD)|
|Study Start Date :||September 2006|
|Estimated Study Completion Date :||October 2008|
- Objective: The differences between baseline and final polysomnographic sleep architecture measurements.
- Subjective:Differences in scores from baseline to trial end on the Sleep Disturbance Scale for Children, the Children's Sleep habits Questionnaire, and scales of Aggressive or maladaptive behaviour (Parent,Teacher and Self reports).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00152750
|Contact: Robyn J Stephens, PhD. C.Psych||416-368-4896 ext firstname.lastname@example.org|
|Contact: Paul Sandor, MD, FRCPCemail@example.com|
|Youthdale Treatment Centres||Recruiting|
|Toronto, Ontario, Canada, M5B 1T8|
|Contact: Robyn J Stephens, PhD. C.Psych 416-368-4896 ext 2874 firstname.lastname@example.org|
|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|