Recruiting

Clonidine

Sponsor:

University Health Network, Toronto

Code:

NCT00152750

Conditions

Tourette's Syndrome

Attention Deficit Hyperactivity Disorder

Eligibility Criteria

Sex: All

Age: 9 - 14

Healthy Volunteers: Accepted

Interventions

APO-clonidine

Study Details

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

Conditions

Tourette's Syndrome

Attention Deficit Hyperactivity Disorder

Study ID

NCT00152750

Start date

Sep, 2006

Status verified date

Oct, 2006

Completion date

Oct, 2008

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 9 - 14

Healthy Volunteers: Accepted

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 Design

Enrollment

32 participants

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

APO-clonidine

Primary outcome measure

  • Objective: The differences between baseline and final polysomnographic sleep architecture measurements. [ Time Frame: undefined ]

Central Contacts and Locations

Central contacts

Robyn J Stephens, PhD. C.Psych

416-368-4896rstephens@youthdale.ca

Paul Sandor, MD, FRCPC

416-603-5794paul.sandor@uhn.on.ca

Locations

Youthdale Treatment Centres

Recruiting

Toronto, Ontario, Canada, M5B 1T8

Contacts

Robyn J Stephens, PhD. C.Psych

416-368-4896rstephens@youthdale.ca

Principal Investigator:

Robyn J Stephens, PhD. CPsych

More Information

Sponsor

University Health Network, Toronto

Last update posted

Feb 28, 2007

Last verified

Oct, 2006

Keywords

  • Tourette's Syndrome
  • Attention Deficit Hyperactivity Disorder
  • Children
  • Sleep disorders
  • Aggression

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2007-02-28.