N-acetylcysteine (NAC) for Children With Tourette Syndrome
الكلمات الدالة
نبذة مختصرة
تواريخ
آخر التحقق: | 11/30/2016 |
تم الإرسال لأول مرة: | 07/26/2010 |
تم إرسال التسجيل المقدر: | 07/27/2010 |
أول نشر: | 07/28/2010 |
تم إرسال آخر تحديث: | 12/18/2016 |
آخر تحديث تم نشره: | 02/09/2017 |
تاريخ أول النتائج المقدمة: | 06/29/2016 |
تاريخ أول نتائج مراقبة الجودة المقدمة: | 10/24/2016 |
تاريخ أول النتائج المنشورة: | 12/18/2016 |
تاريخ بدء الدراسة الفعلي: | 06/30/2010 |
تاريخ الإنجاز الأساسي المقدر: | 12/31/2013 |
التاريخ المتوقع لانتهاء الدراسة: | 12/31/2013 |
حالة أو مرض
التدخل / العلاج
Drug: N-Acetylcysteine
Drug: Placebo
مرحلة
مجموعات الذراع
ذراع | التدخل / العلاج |
---|---|
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. |
معايير الأهلية
الأعمار المؤهلة للدراسة | 8 Years إلى 8 Years |
الأجناس المؤهلة للدراسة | All |
يقبل المتطوعين الأصحاء | نعم |
المعايير | 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) |
النتيجة
مقاييس النتائج الأولية
1. Improvement in Tic Severity [12 weeks]
مقاييس النتائج الثانوية
1. Improvement of Premonitory Urges [12 weeks]
2. Improvement in OCD Severity [12 weeks]
3. Overall Improvement [12 weeks]
4. Number of Participants With Adverse Effects [12 weeks]