Study of Clonidine on Sleep Architecture in Children With Tourette's Syndrome (TS) and Comorbid ADHD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
The Hospital for Sick Children
Information provided by:
University Health Network, Toronto

Brief Summary:
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 or disease Intervention/treatment Phase
Tourette's Syndrome Attention Deficit Hyperactivity Disorder Drug: APO-clonidine Phase 4

Detailed Description:

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)
Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Aggressive Behaviour in Children With Tourette's Syndrome (TS) and Comorbid Attention Deficit Hyperactivity Disorder (ADHD)
Study Start Date : September 2006
Study Completion Date : October 2008

Primary Outcome Measures :
  1. Objective: The differences between baseline and final polysomnographic sleep architecture measurements.

Secondary Outcome Measures :
  1. 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).

Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Males or females
  • Meet the DSM-III-R criteria for Tourette syndrome based on the assessment of a study psychiatrist and the presence of comorbid Attention Deficit Hyperactivity Disorder (ADHD) according to DSM-IV diagnostic criteria
  • A negative history of psychiatric illness that requires treatment.
  • Medication free for a minimum period of six (6) weeks at the time of entry into the study
  • Between the ages of 9:0 years and 14:11 years
  • An initial screening score on the Children’s Aggression Scale-Parents Version of at least +1SD above average on at one or more of the four subscales.
  • Adequate English language comprehension and production (sufficient to respond to questions from the investigators)
  • Be able and willing to cooperate with the study protocol
  • All parents/caregivers will provide consent and subjects (children/adolescents) will give their informed assent prior to participating in any study procedures.
  • Known history of sleep disturbances (children will be considered to experience sleep disturbances if their sleep latency regularly exceeds 30 minutes; to have a general poor quality of sleep if there are frequent awakenings (>2 nightly), nightmares or restlessness; or if they experience difficulty awakening, marked difficulty with arousal or consistent oversleeping. For the purposes of this study, a disturbance in sleep is considered only if it is chronic (lasting more than one month) and frequent (two or more times per week).

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00152750

Contact: Robyn J Stephens, PhD. C.Psych 416-368-4896 ext 2260
Contact: Paul Sandor, MD, FRCPC 416-603-5794

Canada, Ontario
Youthdale Treatment Centres Recruiting
Toronto, Ontario, Canada, M5B 1T8
Contact: Robyn J Stephens, PhD. C.Psych    416-368-4896 ext 2874   
Principal Investigator: Robyn J Stephens, PhD. CPsych         
Sub-Investigator: Paul Sandor, MD, FRCPC         
Sub-Investigator: Colin M Shapiro, MD, FRCPC         
Sponsors and Collaborators
University Health Network, Toronto
The Hospital for Sick Children
Principal Investigator: Robyn J Stephens, PhD.C.Psych. Youthdale Treatment Centres

Additional Information: Identifier: NCT00152750     History of Changes
Other Study ID Numbers: StephensClonidine2005
SickKids #XG05-032
REB 130/2004
First Posted: September 9, 2005    Key Record Dates
Last Update Posted: February 28, 2007
Last Verified: October 2006

Keywords provided by University Health Network, Toronto:
Tourette's Syndrome
Attention Deficit Hyperactivity Disorder
Sleep disorders

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Tourette Syndrome
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Tic Disorders
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antihypertensive Agents
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists