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Open Label Trial of Aripiprazole in Children and Adolescents With Tourette's Disorder

This study is currently recruiting participants.
Verified by New York University School of Medicine, September 2006

Sponsored by: New York University School of Medicine
Information provided by: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT00241176
  Purpose

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).


Condition Intervention Phase
Tourette's Syndrome
Tic Disorders
Drug: Aripiprazole
Phase IV

Genetics Home Reference related topics:   familial encephalopathy with neuroserpin inclusion bodies    familial paroxysmal nonkinesigenic dyskinesia    Tourette syndrome   

MedlinePlus related topics:   Tourette Syndrome   

ChemIDplus related topics:   Aripiprazole   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:   Open Label Trial of Aripiprazole in Children and Adolescents With Tourette's Disorder

Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • We will obtain preliminary data on effect size for tics using Cohen’s d, calculating the difference between the two means (baseline and endpoint scores on the YGTSS), divided by the standard deviation of the difference

Estimated Enrollment:   12
Study Start Date:   September 2005
Estimated Study Completion Date:   August 2007

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
Ages Eligible for Study:   7 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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).
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00241176

Contacts
Contact: Natalie Wieland, M.A.     212-263-8672     natalie.wieland@med.nyu.edu    
Contact: Matthew Schrock     212-263-8992     matthew.schrock@med.nyu.edu    

Locations
United States, New York
NYU Child Study Center     Recruiting
      New York, New York, United States, 10016
      Contact: Natalie Wieland, M.A.     212-263-8672     natalie.wieland@med.nyu.edu    
      Contact: Matthew Schrock     212-263-8992     matthew.schrock@med.nyu.edu    
      Principal Investigator: Barbara J Coffey, M.D., M.S.            

Sponsors and Collaborators
New York University School of Medicine

Investigators
Principal Investigator:     Barbara J Coffey, M.D, M.S.     NYU School of Medicine, NYU Child Study Center    
  More Information


NYU Child Study Center website  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   H12189
First Received:   October 14, 2005
Last Updated:   September 7, 2006
ClinicalTrials.gov Identifier:   NCT00241176
Health Authority:   United States: Institutional Review Board

Keywords provided by New York University School of Medicine:
Psychiatric  
Clinical Trial  
Pediatrics  
Tourette's Disorder  
Tic Disorder  

Study placed in the following topic categories:
Ganglion Cysts
Basal Ganglia Diseases
Central Nervous System Diseases
Tourette Syndrome
Tic Disorders
Neurodegenerative Diseases
Brain Diseases
Dyskinesias
Tics
Signs and Symptoms
Heredodegenerative Disorders, Nervous System
Genetic Diseases, Inborn
Movement Disorders
Mental Disorders
Mental Disorders Diagnosed in Childhood
Neurologic Manifestations
Gilles de la Tourette's syndrome
Aripiprazole

Additional relevant MeSH terms:
Tranquilizing Agents
Pathologic Processes
Disease
Therapeutic Uses
Syndrome
Physiological Effects of Drugs
Nervous System Diseases
Psychotropic Drugs
Central Nervous System Depressants
Antipsychotic Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 17, 2008




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