N-acetylcysteine (NAC) for Pediatric Obsessive-Compulsive Disorder
Condition: Obsessive-Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Intervention: N-Acetylcysteine; Placebo
Intervention description: 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.; 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.
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 11.0
Sex: All
Minimum age: 8 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Obsessive-Compulsive Disorder; OCD

Summary:

      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.
    

Eligibility criteria:

        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.