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

February 27, 2007 updated by: University Health Network, Toronto

Aggressive Behaviour in Children With Tourette's Syndrome (TS) and Comorbid Attention Deficit Hyperactivity Disorder (ADHD)

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment

32

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5B 1T8
        • Recruiting
        • Youthdale Treatment Centres
        • Contact:
        • Principal Investigator:
          • Robyn J Stephens, PhD. CPsych
        • Sub-Investigator:
          • Paul Sandor, MD, FRCPC
        • Sub-Investigator:
          • Colin M Shapiro, MD, FRCPC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Collaborators

The Hospital for Sick Children

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Study Completion

October 1, 2008

Study Registration Dates

First Submitted

September 7, 2005

First Submitted That Met QC Criteria

September 7, 2005

First Posted (Estimate)

September 9, 2005

Study Record Updates

Last Update Posted (Estimate)

February 28, 2007

Last Update Submitted That Met QC Criteria

February 27, 2007

Last Verified

October 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • StephensClonidine2005
  • SickKids #XG05-032
  • REB 130/2004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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