Open Label Trial of Aripiprazole in Children and Adolescents With Tourette's Disorder
Condition: Tourette's Syndrome; Tic Disorders
MeSH terms: Tourette Syndrome; Tic Disorders; Tics
Intervention: Aripiprazole
Intervention description: Baseline Visit 2: Subjects btw 25-50kg start on 1.25mg/day, btw 50-70kg start on 2.5mg/day, greater than 70kg start on 5mg/day Visit 3: Titrated based on YGTSS & CGI-TS ratings at investigator discretion. Subjects who show evidence of response (reduction in CGI-TS by 1-2 points) may remain on same dose. Subjects who show no response may increase as follows: btw 25-50kg increase to 2.5mg/day, btw 50-70kg increase to 3.75mg/day, greater than 70kg increase to 7.5mg/day Visit 5: Subjects who show no response may increase as follows: btw 25-50kg increase to 3.75mg/day, btw 50-70kg increase to 5mg/day, greater than 70kg increase to 10mg/day Visit 6: Subjects who show no response may be increase as follows: btw 25-50kg increase to 5mg/day, btw 50-70kg increase to 7.5mg/day, greater than 70kg increase to 12.5mg/day Visit 7: Subjects who how no response may be increase as follows: btw 25-50kg increase to 7.5mg/day, btw 50-70kg increase to 10mg/day, greater than 70kg increase to 15mg/day
Intervention MeSH terms: Aripiprazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 7 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Psychiatric; Clinical Trial; Pediatrics; Tourette's Disorder; Tic Disorder

Summary:

      The purpose of this study is to determine if Abilify will reduce tics (repetitive,
      uncontrollable movements or vocalizations) in children and adolescents ages 7-18 with
      Tourette's Disorder (TD) or a chronic motor tic disorder (either repetitive, uncontrollable
      movements or vocalizations).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Child or adolescent must be 7 to 18 years of age (inclusive) when informed consent is
             obtained.

          -  Must meet full criteria for Tourette's Disorder or chronic motor tic disorder.

          -  Must have failed to respond to an adequate trial, as determined by the investigator,
             of clonidine, guanfacine, or neuroleptic medication in the past.

          -  Tics are causing significant distress or impairment, as determined by parent/subject
             and principal investigator, on current treatment regimen.

          -  Laboratory results, including serum chemistries, hematology, and urinalysis, must show
             no significant abnormalities (significant is defined as laboratory values requiring
             acute medical intervention).

          -  Must be able to swallow pills.

          -  Must be of normal intelligence in the judgment of the investigator.

          -  Must possess an educational level, degree of understanding and command of the English
             language to enable them to communicate suitably with the investigator and study
             coordinator, and to understand the nature of the study.

          -  Subjects and their legal representatives must be considered reliable.

          -  Written informed consent of parents and subjects (ages 18 and above) and assent of
             subjects ages 7-17 will be obtained.

        Exclusion Criteria:

          -  Organic brain disease, for example, traumatic brain injury residua.

          -  Mental retardation as defined by the DSM-IV-TR.

          -  A history of seizure disorder (other than febrile seizure).

          -  A history of Sydenham's Chorea.

          -  Autism, schizophrenia, other psychotic disorder, or bipolar disorder.

          -  A primary diagnosis of a major mood disorder that requires ongoing psychiatric
             treatment.

          -  A neurological disorder other than a tic disorder.

          -  A major medical illness.

          -  Females who are of child bearing age who are unwilling to use birth control or who are
             pregnant, as determined by serum pregnancy test at baseline assessment, or lactating.

          -  Have a past or current history of substance dependence and/or a current history of
             substance abuse or who fail baseline toxic screen.

          -  Have any clinically significant abnormal laboratory result at baseline screening
             including EKG, or blood tests.

          -  Have a history of ongoing or previously undisclosed child abuse (risk of removal from
             home would not allow for consistent caretaker ratings).