Diseases and Conditions Researched
Tic; Tourettes Syndrome
What is the purpose of this trial?
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.
Participation Guidelines
Age: 8 Years - 17 Years
Gender: Both
Click here for
detailed participation information for this trial.
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Sponsors:
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American Academy of Child Adolescent Psychiatry.; Yale University |
| Dates: |
July 27, 2010 |
| Last Updated: |
October 3, 2012 |
| Study HIC#: |
1004006637 |
| Clinicaltrials.gov ID: |
NCT01172288
|
Conditions
Tic; Tourettes Syndrome
Interventions Details
| Drug:
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N-Acetylcysteine (NAC) |
| Drug:
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Placebo |
Trial Phase
Phase 2
Trial 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.
Participation Guidelines
Age: 8 Years - 17 Years
Gender: Both
Eligibility Criteria
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)
Publications
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Berk M, Copolov D, Dean O, Lu K, Jeavons S, Schapkaitz I, Anderson-Hunt M, Judd F, Katz F, Katz P, Ording-Jespersen S, Little J, Conus P, Cuenod M, Do KQ, Bush AI. N-acetyl cysteine as a glutathione precursor for schizophrenia--a double-blind, randomized, placebo-controlled trial. Biol Psychiatry. 2008 Sep 1;64(5):361-8. Epub 2008 Apr 23.
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Berk M, Copolov DL, Dean O, Lu K, Jeavons S, Schapkaitz I, Anderson-Hunt M, Bush AI. N-acetyl cysteine for depressive symptoms in bipolar disorder--a double-blind randomized placebo-controlled trial. Biol Psychiatry. 2008 Sep 15;64(6):468-75. Epub 2008 Jun 5.
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Bloch MH, Leckman JF. Clinical course of Tourette syndrome. J Psychosom Res. 2009 Dec;67(6):497-501. Review.
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Grant JE, Odlaug BL, Kim SW. N-acetylcysteine, a glutamate modulator, in the treatment of trichotillomania: a double-blind, placebo-controlled study. Arch Gen Psychiatry. 2009 Jul;66(7):756-63.
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Ng F, Berk M, Dean O, Bush AI. Oxidative stress in psychiatric disorders: evidence base and therapeutic implications. Int J Neuropsychopharmacol. 2008 Sep;11(6):851-76. Epub 2008 Jan 21. Review.
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Singer HS, Morris C, Grados M. Glutamatergic modulatory therapy for Tourette syndrome. Med Hypotheses. 2010 May;74(5):862-7. Epub 2009 Dec 21.
|
Sponsors:
|
American Academy of Child Adolescent Psychiatry.; Yale University |
| Dates: |
July 27, 2010 |
| Last Updated: |
October 3, 2012 |
| Study HIC#: |
1004006637 |
| Clinicaltrials.gov ID: |
NCT01172288
|