N-acetylcysteine (NAC) for Pediatric Obsessive-Compulsive Disorder
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.
|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 Pediatric Obsessive-Compulsive Disorder|
- Improvement in OCD Severity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS)
- Improvement in OCD Symptom Dimensions [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Dimensional Yale-Brown Obsessive-Compulsive Scale (DY-BOCS)
- Overall Improvement [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Clinician Global Improvement Scale (CGI)
- Adverse Effects [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]Pediatric Adverse Events Rating Scale (PAERS)
|Study Start Date:||July 2012|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
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||
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.
|Contact: Jilian Mulqueen, BA||(203) firstname.lastname@example.org|
|Contact: Michael H. Bloch, MD, MS||(203) email@example.com|
|United States, Connecticut|
|Yale Child Study Center||Recruiting|
|New Haven, Connecticut, United States, 06520|
|Principal Investigator:||Michael H. Bloch, MD, MS||Yale University|