Open Label Trial of Aripiprazole in Children and Adolescents With Tourette's Disorder
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).
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Open Label Trial of Aripiprazole in Children and Adolescents With Tourette's Disorder|
- Calculating Difference Between Means (Baseline and Endpoint Scores on the Yale Global Tic Severity Scale Subscales) [ Time Frame: Baseline, Weekly Visits, Endpoint ] [ Designated as safety issue: No ]The Yale Global Tic Severity Scale (YGTSS) is a clinical rating instrument that was designed for use in studies of Tourette's syndrome and other tic disorders. The YGTSS provides an evaluation of the number, frequency, intensity, complexity, and interference of motor and phonic symptoms. The maximum YGTSS Global score is 100, while the maximum motor score is 25, the maximum vocal score is 25, and the maximum impairment score is 50. Higher scores indicate more severe tics.
- Clinical Global Impression Severity Scores [ Time Frame: Baseline and Endpoint (Week 8, Visit 8) ] [ Designated as safety issue: No ]The Clinical Global Impression scale (CGI) is a classic instrument for making global assessments. This scale yields three different measures: 1. Severity of illness (7-point scale, with 7 being the most impaired; assessment of patient's current symptom severity, referred to here as CGIs), 2. Global improvement (7-point scale, with 7 being the most impaired; comparison of patient's baseline condition with his/her current condition, referred to here as CGIi), 3. Efficacy index (4 point x 4 point rating scale, comparison of patient's baseline condition with a ratio of current therapeutic benefit to severity of side effects)
|Study Start Date:||September 2005|
|Study Completion Date:||February 2010|
|Primary Completion Date:||August 2008 (Final data collection date for primary outcome measure)|
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
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.
|United States, New York|
|NYU Child Study Center|
|New York, New York, United States, 10016|
|Principal Investigator:||Barbara J Coffey, M.D, M.S.||NYU School of Medicine, NYU Child Study Center|