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

Primary Purpose

Tourette's Syndrome, Attention Deficit Hyperactivity Disorder

Status
Unknown status
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
APO-clonidine
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tourette's Syndrome focused on measuring Tourette's Syndrome, Attention Deficit Hyperactivity Disorder, Children, Sleep disorders, Aggression

Eligibility Criteria

9 Years - 14 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Youthdale Treatment CentresRecruiting

Outcomes

Primary Outcome Measures

Objective: The differences between baseline and final polysomnographic sleep architecture measurements.

Secondary Outcome Measures

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).

Full Information

First Posted
September 7, 2005
Last Updated
February 27, 2007
Sponsor
University Health Network, Toronto
Collaborators
The Hospital for Sick Children
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1. Study Identification

Unique Protocol Identification Number
NCT00152750
Brief Title
Study of Clonidine on Sleep Architecture in Children With Tourette's Syndrome (TS) and Comorbid ADHD
Official Title
Aggressive Behaviour in Children With Tourette's Syndrome (TS) and Comorbid Attention Deficit Hyperactivity Disorder (ADHD)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2006
Overall Recruitment Status
Unknown status
Study Start Date
September 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2008 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University Health Network, Toronto
Collaborators
The Hospital for Sick Children

4. Oversight

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tourette's Syndrome, Attention Deficit Hyperactivity Disorder
Keywords
Tourette's Syndrome, Attention Deficit Hyperactivity Disorder, Children, Sleep disorders, Aggression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
32 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
APO-clonidine
Primary Outcome Measure Information:
Title
Objective: The differences between baseline and final polysomnographic sleep architecture measurements.
Secondary Outcome Measure Information:
Title
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).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Robyn J Stephens, PhD. C.Psych
Phone
416-368-4896
Ext
2260
Email
rstephens@youthdale.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Paul Sandor, MD, FRCPC
Phone
416-603-5794
Email
paul.sandor@uhn.on.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robyn J Stephens, PhD.C.Psych.
Organizational Affiliation
Youthdale Treatment Centres
Official's Role
Principal Investigator
Facility Information:
Facility Name
Youthdale Treatment Centres
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1T8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robyn J Stephens, PhD. C.Psych
Phone
416-368-4896
Ext
2874
Email
rstephens@youthdale.ca
First Name & Middle Initial & Last Name & Degree
Robyn J Stephens, PhD. CPsych
First Name & Middle Initial & Last Name & Degree
Paul Sandor, MD, FRCPC
First Name & Middle Initial & Last Name & Degree
Colin M Shapiro, MD, FRCPC

12. IPD Sharing Statement

Links:
URL
http://www.youthdale.ca
Description
Youthdale Treatment Centres

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

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