Status:
UNKNOWN
Study of Clonidine on Sleep Architecture in Children With Tourette's Syndrome (TS) and Comorbid ADHD
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
The Hospital for Sick Children
Conditions:
Tourette's Syndrome
Attention Deficit Hyperactivity Disorder
Eligibility:
All Genders
9-14 years
Phase:
PHASE4
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 conside...
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 eviden...
Eligibility Criteria
Inclusion
- 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
- \*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
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
End Date :
October 1 2008
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00152750
Start Date
September 1 2006
End Date
October 1 2008
Last Update
February 28 2007
Active Locations (1)
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1
Youthdale Treatment Centres
Toronto, Ontario, Canada, M5B 1T8