Last Verified: | November/30/2016 |
First Submitted: | July/26/2010 |
Estimated Enrollment Submitted: | July/27/2010 |
First Posted: | July/28/2010 |
Last Update Submitted: | December/18/2016 |
Last Update Posted: | February/9/2017 |
: | June/29/2016 |
: | October/24/2016 |
: | December/18/2016 |
Actual Study Start Date: | June/30/2010 |
Estimated Primary Completion Date: | December/31/2013 |
Estimated Study Completion Date: | December/31/2013 |
Study Type: | Interventional |
Allocation: | Randomized |
Primary Purpose: | Treatment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Arm | Intervention/treatment |
---|---|
Experimental: N-Acetylcysteine NAC was titrated up to a maximum dose of 2400 mg over the course of 2 weeks. Subjects were assigned 600 mg twice a day for weeks 1-2, and then were assigned 1200 mg twice a day for the remainder of the 12 week study. | Drug: N-Acetylcysteine 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 Placebo: Subjects were assigned to take two capsules twice a day for weeks 1-2, and then were assigned 4 capsules twice a day for the remainder of the 12 week study. | 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. |
Ages Eligible for Study: | 8 Years to 8 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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) |