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

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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)

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.
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

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

Secondary Outcome

 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).

Condition

Tourette's Syndrome

Intervention

APO-clonidine


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

32

Start Date

September 2006

Completion Date

October 2008


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
      

Gender

All

Ages

9 Years - 14 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Robyn J Stephens, PhD.C.Psych., 416-368-4896, [email protected]

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT00152750

Organization ID

StephensClonidine2005

Secondary IDs

SickKids #XG05-032


Study Sponsor

University Health Network, Toronto

Collaborators

 The Hospital for Sick Children

Study Sponsor

Robyn J Stephens, PhD.C.Psych., Principal Investigator, Youthdale Treatment Centres


Verification Date

October 2006