Status:
COMPLETED
Open Label Trial of Aripiprazole in Children and Adolescents With Tourette's Disorder
Lead Sponsor:
NYU Langone Health
Conditions:
Tourette's Syndrome
Tic Disorders
Eligibility:
All Genders
7-18 years
Phase:
PHASE4
Brief 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 c...
Detailed Description
The aims of this study are to obtain systematic data regarding dosing and safety of aripiprazole (Abilify) in the treatment of youth with Tourette's Disorder (TD). Tourette's Disorder is characterized...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00241176
Start Date
September 1 2005
End Date
February 1 2010
Last Update
December 9 2016
Active Locations (1)
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1
NYU Child Study Center
New York, New York, United States, 10016