Clinical trial NCT00241176: Open Label Trial of Aripiprazole in Children and Adolescents With Tourette's Disorder
Official title: Open Label Trial of Aripiprazole in Children and Adolescents With Tourette's Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tourette's Syndrome
Tic Disorders
Keywords: Psychiatric
Clinical Trial
Pediatrics
Tourette's Disorder
Tic Disorder
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2005-10-18
Enrollment: 11
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 chronic motor tic disorder (either repetitive, uncontrollable movements or vocalizations).

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 by multiple motor (more than one uncontrollable movement) and vocal tics (vocal outbursts) which have been present for more than 1 year, with onset before the age of 18. The disorder causes marked distress in social, occupational or other important areas of functioning. Abilify has been approved by the United States Food and Drug Administration (FDA) to treat adults with schizophrenia but has not been approved to treat Tourette's Disorder (TD) so it is considered experimental or investigational in this study.

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).

Primary outcomes:
measure: Calculating Difference Between Means (Baseline and Endpoint Scores on the Yale Global Tic Severity Scale Subscales)
timeFrame: 8 Weeks
Secondary outcomes:
measure: Clinical Global Impression Severity Scores
timeFrame: 24 Months
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Child Study Center
state: New York
Study officials:
affiliation: NYU School of Medicine, NYU Child Study Center
name: Barbara J Coffey, M.D, M.S.
role: PRINCIPAL_INVESTIGATOR
References: