N-acetylcysteine (NAC) for Children With Tourette Syndrome
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Purpose
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 pharmacological treatments for childhood tics including alpha-2 agonist medications (guanfacine and clonidine) and neuroleptics (antipsychotic) medications. These medications, however, have significant side-effects and are only partially efficacy in treating tics.
N-acetylcysteine (NAC) is a natural supplement that acts as an antioxidant and glutamate modulating agent. NAC has been used safely for decades in doses 20-40 times higher than in this trial as an antidote for acetaminophen overdose. The only side-effect commonly seen with NAC is nausea and this side-effect is seldom seen in the doses used in this trial.
NAC has recently been demonstrated to be effective in a double-blind, placebo-controlled trial in adults with trichotillomania (chronic hair pulling). Hairpulling is hypothesized to be closely related to tics because these conditions (1) have similar clinical characteristics -- both groups typically experience urges before engaging in pulling or tics, (2) neuroimaging studies suggest they involve similar brain circuits -- the basal ganglia, (3) the same pharmacological treatments (neuroleptics) may be effective for both conditions and (4) they tend to be inherited together in families. In other trials NAC has evidence of some efficacy in treating diverse psychiatric conditions such as bipolar depression, schizophrenia and cocaine dependence.
The investigators are conducting this trial to determine if NAC is an effective treatment for tics.
| Condition | Intervention | Phase |
|---|---|---|
|
Tourettes Syndrome Tic |
Drug: N-Acetylcysteine (NAC) Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Double-Blind, Placebo-Controlled Trial of N-acetylcysteine (NAC) for the Treatment of Children With Tourette Syndrome |
- Improvement in Tic Severity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Yale Global Tic Severity Scale (Total Tic Score)
- Improvement of Premonitory Urges [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Premonitory Urge for Tics Scale (PUTS)
- Improvement in OCD Severity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Childrens' Yale-Brown Obsessive-Compulsive Scale (CY-BOCS)
- Overall Improvement [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Clinical Global Improvement Scale
- Adverse Effects [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Pediatric Adverse Events Rating Scale
| Estimated Enrollment: | 40 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: N-Acetylcysteine |
Drug: N-Acetylcysteine (NAC)
1 600mg capsule twice a day for 2 weeks and then 2 600mg capsules twice a day for the remaining 10 weeks of the trial.
|
| Placebo Comparator: Placebo |
Drug: Placebo
1 600mg Capsule twice a day for two weeks then 2 600mg capsules twice a day for the remaining 10 weeks of the study. Children receiving placebo will be offered the active intervention after the double-blind portion of the trial.
|
Eligibility| Ages Eligible for Study: | 8 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- 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)
Contacts and Locations| Contact: Jilian Mulqueen, BA | (203) 737-4809 | jilian.mulqueen@yale.edu |
| Contact: Michael H. Bloch, MD, MS | (203) 974-7551 | michael.bloch@yale.edu |
| United States, Connecticut | |
| Yale Child Study Center | Recruiting |
| New Haven, Connecticut, United States, 06520 | |
| Principal Investigator: | Michael H. Bloch, MD, MS | Yale University |
More Information
Publications:
| Responsible Party: | Michael Bloch, Assistant Professor, Yale University |
| ClinicalTrials.gov Identifier: | NCT01172288 History of Changes |
| Other Study ID Numbers: | YCSC1004006637 |
| Study First Received: | July 27, 2010 |
| Last Updated: | October 3, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Yale University:
|
Tic disorders, Tourette syndrome Chronic Tic Disorders |
Additional relevant MeSH terms:
|
Tourette Syndrome Tics Dyskinesias Neurologic Manifestations Nervous System Diseases Signs and Symptoms Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Tic Disorders Movement Disorders Heredodegenerative Disorders, Nervous System Neurodegenerative Diseases Genetic Diseases, Inborn Mental Disorders Diagnosed in Childhood |
Mental Disorders Acetylcysteine N-monoacetylcystine Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Expectorants Respiratory System Agents Free Radical Scavengers Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Antidotes |
ClinicalTrials.gov processed this record on June 17, 2013