Open Label Trial of Aripiprazole in Children and Adolescents With Tourette's Disorder
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ClinicalTrials.gov Identifier: NCT00241176 |
Recruitment Status :
Completed
First Posted : October 18, 2005
Results First Posted : January 25, 2013
Last Update Posted : December 9, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Tourette's Syndrome Tic Disorders | Drug: Aripiprazole | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 11 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Open Label Trial of Aripiprazole in Children and Adolescents With Tourette's Disorder |
Study Start Date : | September 2005 |
Actual Primary Completion Date : | August 2008 |
Actual Study Completion Date : | February 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: Aripiprazole |
Drug: Aripiprazole
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 |
- Calculating Difference Between Means (Baseline and Endpoint Scores on the Yale Global Tic Severity Scale Subscales) [ Time Frame: 8 Weeks ]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: 24 Months ]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)

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Ages Eligible for Study: | 7 Years to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00241176
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 |
Responsible Party: | NYU Langone Health |
ClinicalTrials.gov Identifier: | NCT00241176 |
Other Study ID Numbers: |
H12189 |
First Posted: | October 18, 2005 Key Record Dates |
Results First Posted: | January 25, 2013 |
Last Update Posted: | December 9, 2016 |
Last Verified: | October 2016 |
Psychiatric Clinical Trial Pediatrics Tourette's Disorder Tic Disorder |
Tourette Syndrome Tic Disorders Tics Disease Pathologic Processes Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Heredodegenerative Disorders, Nervous System Neurodegenerative Diseases Genetic Diseases, Inborn Neurodevelopmental Disorders Mental Disorders |
Dyskinesias Neurologic Manifestations Aripiprazole Antidepressive Agents Psychotropic Drugs Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Dopamine Agonists Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin 5-HT1 Receptor Agonists Serotonin Receptor Agonists |