N-acetylcysteine (NAC) for Pediatric Obsessive-Compulsive Disorder
Status:
Completed
Sponsors
Yale University
Abstract:
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.
Last Verified:July/31/2019
First Submitted:July/26/2010
Estimated Enrollment Submitted:July/27/2010
First Posted:July/28/2010
Last Update Submitted:August/13/2019
Last Update Posted:September/5/2019
:July/21/2019
:August/13/2019
:September/5/2019
Actual Study Start Date:June/30/2012
Estimated Primary Completion Date:February/12/2017
Estimated Study Completion Date:February/14/2018
Condition or disease:Obsessive-Compulsive Disorder
Intervention/treatment:
Drug: N-Acetylcysteine
Other: Placebo
Phase:Phase 2
Study design:
Study Type:Interventional
Allocation:Randomized
Primary Purpose:Treatment
Masking:Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm group:
ArmIntervention/treatment
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.
Eligibility Criteria:
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 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.

Outcome:
Primary Outcome Measures
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)
Secondary Outcome Measures
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
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