N-acetylcysteine (NAC) for Pediatric Obsessive-Compulsive Disorder

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الحالةمنجز

الرعاة

Yale University

تجربة سريرية: NCT01172275

BioSeek: NCT01172275

الكلمات الدالة

نبذة مختصرة

Pediatric Obsessive-Compulsive Disorder (OCD) affects 1-3% of children. The investigators currently have effective first-line interventions for pediatric OCD such as Cognitive Behavioral Therapy (CBT) and pharmacotherapy with serotonin reuptake inhibitors (SRIs). However, roughly half of children with OCD still have clinically significant OCD symptoms despite treatment with first-line pharmacological treatments and CBT interventions for OCD. Furthermore, all pharmacological treatments for OCD in children have an increased side effect burden when compared to adults. Novel treatments for children with OCD are needed.

N-acetylcysteine (NAC) is a natural supplement that acts as an antioxidant and a 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). Trichotillomania is an obsessive-compulsive spectrum disorder that is hypothesized to be closely related to OCD. 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 effective in treating OCD.

تواريخ

آخر التحقق:	07/31/2019
تم الإرسال لأول مرة:	07/26/2010
تم إرسال التسجيل المقدر:	07/27/2010
أول نشر:	07/28/2010
تم إرسال آخر تحديث:	08/13/2019
آخر تحديث تم نشره:	09/05/2019
تاريخ أول النتائج المقدمة:	07/21/2019
تاريخ أول نتائج مراقبة الجودة المقدمة:	08/13/2019
تاريخ أول النتائج المنشورة:	09/05/2019
تاريخ بدء الدراسة الفعلي:	06/30/2012
تاريخ الإنجاز الأساسي المقدر:	02/12/2017
التاريخ المتوقع لانتهاء الدراسة:	02/14/2018

حالة أو مرض

Obsessive-Compulsive Disorder

التدخل / العلاج

Drug: N-Acetylcysteine

Other: Placebo

مرحلة

مرحلة 2

مجموعات الذراع

ذراع	التدخل / العلاج
Experimental: N-Acetylcysteine N-Acetylcysteine effervescent tablets. 1 900mg tablet once a day for 1 week, then 1 900mg tablet twice a day for 1 week and then 1 900mg tablet three times a day for the remaining 10 weeks of the trial.	Drug: N-Acetylcysteine 1 900mg tablet once a day for 1 week, then 1 900mg tablet twice a day for 1 week and then 1 900mg tablet three times a day for the remaining 10 weeks of the trial.
Placebo Comparator: Placebo Placebo effervescent tablets. 1 900mg tablet once a day for 1 week, then 1 900mg tablet twice a day for 1 week and then 1 900mg tablet three times a day for the remaining 10 weeks of the trial. Children receiving placebo will be offered the active intervention after the double-blind portion of the trial.	Other: Placebo 1 900mg tablet once a day for 1 week, then 1 900mg tablet twice a day for 1 week and then 1 900mg tablet three times a day for the remaining 10 weeks of the trial. 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 OCD. - Duration of OCD greater than 6 months. - Significant Current OCD symptoms: Current CY-BOCS score > or = 16. 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 OCD severity (such as Selective Serotonin Reuptake Inhibitors, clomipramine, naltrexone, lithium, psychostimulants, anxiolytics, or antipsychotics). Medication change is defined to include either dose changes or medication discontinuation. - Recent change in behavioral treatment for OCD or comorbid conditions 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 (case reports have linked intravenous NAC administration with asthma exacerbation) - 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). - Previous history or suspicion of cystinuria because of a possibility of forming kidney stones.

النتيجة

مقاييس النتائج الأولية

1. OCD Severity at 12 Weeks [12 weeks]

Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) (0-7:Subclinical, 8-15: Mild, 16-23: Moderate, 24-31: Severe, 32-40: Extreme)

مقاييس النتائج الثانوية

1. Overall Improvement at 12 Weeks [12 weeks]

Clinician Global Improvement Scale (CGI) 0=Not assessed 4=Moderately ill Normal, not at all ill 5=Markedly ill Borderline mentally ill 6=Severly ill Mildly ill 7=Very much worse

N-acetylcysteine (NAC) for Pediatric Obsessive-Compulsive Disorder

الكلمات الدالة

n acetylcysteine

سيروتونين

غثيان

أسيتيل سيستئين

كوكايين

مضاد تأكسد

ترياق