Status:
COMPLETED
N-acetylcysteine (NAC) for Children With Tourette Syndrome
Lead Sponsor:
Yale University
Collaborating Sponsors:
American Academy of Child Adolescent Psychiatry.
Conditions:
Tourettes Syndrome
Tic
Eligibility:
All Genders
8-17 years
Phase:
PHASE2
Brief Summary
Tourette syndrome is a childhood-onset neuropsychiatric disorder characterized by multiple motor and vocal tics that last for at least a year in duration. Currently, there exist several effective phar...
Eligibility Criteria
Inclusion
- Children aged 8-17 years.
- Primary diagnosis of Tourette syndrome or chronic tic disorder.
- Duration of tics greater than 1 year.
- Significant Current tic symptoms: Current YGTSS score greater than or equal to 22 with a TS diagnosis or greater than or equal to 14 with a chronic tic disorder.
Exclusion
- Comorbid bipolar disorder, psychotic disorder, substance use disorder, developmental disorder or mental retardation (IQ\<70).
- Recent change (less than 4 weeks) in medications that have potential effects on tic severity (such as neuroleptic medications, dopamine agonists, alpha-2 agonists (guanfacine, clonidine or prazosin), SSRIs, clomipramine, naltrexone, lithium, psychostimulants, or anxiolytics). Medication change is defined to include dose changes or medication discontinuation.
- Recent change in behavioral treatment for Tourette syndrome or comorbid conditions (i.e. OCD) within the last 4 weeks or initiation of behavioral therapy for tics within the last 12 weeks.
- Asthma requiring medication use within the last 3 months
- Known hypersensitivity or previous anaphylactoid reaction to acetylcysteine or any components in its preparation
- Positive pregnancy test or drug screening test.
- Previous use of N-acetylcysteine (dose greater than 600mg for more than 2 weeks)
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT01172288
Start Date
July 1 2010
End Date
January 1 2014
Last Update
February 10 2017
Active Locations (1)
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1
Yale Child Study Center
New Haven, Connecticut, United States, 06520