None listed
Conditions
Interventions
A TOTAL OF 126 SUBJECTS IN 2 WEIGHT GROUPS (LOW: < 50 KG
HIGH: ≥
50 KG) WILL BE RANDOMIZED TO ARIPIPRAZOLE LOW DOSE, ARIPIPRAZOLE HIG DOSE, OR PLACEBO IN A 1:1:1 RATIO. THE ARIPIPRAZOLE LOW DOSE IS 5.0 MG/DAY FOR THE LOW-WEIGHT GROUP AND 10.0 MG/DAY FOR THE HIGH-WE
THE ARIPIPRAZOLE HIGH DOSE IS 10.0 MG/DAY FOR THE LOW WEIGHT
GROUP AND 20.0 MG/DAY FOR THE HIGH-WEIGHT GROUP. FORTY-TWO SUBJECTS EACH IN THE ARIPIPRAZOLE LOW- AND HIGH-DOSE GROUPS AND 42 SUBJECTS I
Sponsors
OTSUKA PHARMACEUTICAL DEVELOPMENT & COMMERCIALIZATION, INC.,
Eligibility
Sex/Gender
All
Age
7 Years to 17 Years
Inclusion criteria
Inclusion criteria: 1. THE SUBJECT IS A MALE OR FEMALE CHILD OR ADOLESCENT, 7-17 YEARS OF AGE (INCLUSIVE) AT THE TIME OF SIGNING THE INFORMED CONSENT/ASSENT. 2. THE SUBJECT MEETS CURRENT DSM-IV-TR DIAGNOSTIC CRITERIA FOR TOURETTE´S DISORDER, DOCUMENTED AT SCREENING AND MADE BY AN ADEQUATELY TRAINED CLINICIAN, AS CONFIRMED BY THE K-SADS-PL, INCLUDING THE DIAGNOSTIC SUPPLEMENT 5 (SUBSTANCE ABUSE AND OTHER DISEASES, IE, TIC DISORDERS). 3. THE SUBJECT HAS A TTS ≥ 20 ON THE YGTSS AT SCREENING AND BASELINE (RANDOMIZATION). 4. THE SUBJECT, A CAREGIVER, AND THE INVESTIGATOR MUST ALL AGREE THAT THE PRESENTING TIC SYMPTOMS CAUSE IMPAIRMENT IN THE SUBJECT´S NORMAL ROUTINES, WHICH INCLUDE ACADEMIC ACHIEVEMENT, OCCUPATIONAL FUNCTIONING, SOCIAL ACTIVITIES, AND/OR RELATIONSHIPS. 5. FEMALES OF CHILDBEARING POTENTIAL (DEFINED BY MENARCHE AND NOT HAVING UNDERGONE SURGICAL STERILIZATION/HYSTERECTOMY) MUST HAVE A NEGATIVE PREGNANCY TEST, MUST BE PRACTICING ACCEPTABLE DOUBLE-BARRIER METHODS OF CONTRACEPTION (OR CAN CONFIRM ABSTINENCE AT EACH SCHEDULED VISIT), AND MUST NOT BE PREGNANT OR LACTATING.
Exclusion criteria
Exclusion criteria: 1. THE SUBJECT PRESENTS WITH A CLINICAL PRESENTATION AND/OR HISTORY THAT IS CONSISTENT WITH ANOTHER NEUROLOGIC CONDITION THAT MAY HAVE ACCOMPANYING ABNORMAL MOVEMENTS. THESE INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING: • TRANSIENT TIC DISORDER • HUNTINGTON´S DISEASE • PARKINSON´S DISEASE • SYDENHAM´S CHOREA • WILSON´S DISEASE • MENTAL RETARDATION • PERVASIVE DEVELOPMENTAL DISORDER • TRAUMATIC BRAIN INJURY • STROKE • RESTLESS LEGS SYNDROME 2. THE SUBJECT HAS A HISTORY OF SCHIZOPHRENIA, BIPOLAR DISORDER, OR OTHER PSYCHOTIC DISORDER. 3. SUBJECTS WHO RECEIVE PSYCHOSTIMULANTS FOR THE TREATMENT OF ADD/ADHD AND WHO HAVE DEVELOPED AND/OR HAD EXACERBATIONS OF THE TIC DISORDER AFTER THE INITIATION OF STIMULANT TREATMENT. (NOTE THAT SUBJECTS WITH ADD/ADHD WHO ARE TREATED WITH PSYCHOSTIMULANTS AND HAVE NOT DEVELOPED NEW TICS OR A WORSENING OF THEIR CURRENT TICS CAN BE INCLUDED IF ALL OTHER ENROLLMENT OBLIGATIONS ARE MET). 4. THE SUBJECT CURRENTLY MEETS DSM-IV-TR CRITERIA FOR A PRIMARY MOOD DISORDER.
Countries
Argentina, Belgium, Bulgaria, Canada, Finland, Germany, Hungary, Italy, Mexico, Netherlands, Peru, Poland, Romania, Spain, Sweden, United Kindgdom, United States
Contacts
Public ContactSarita Mattos
SYNEOS HEALTH PERU S.R.L.
Outcome results
None listed