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

August 14, 2019 updated by: Yale University

Double-Blind, Placebo-Controlled Trial of N-acetylcysteine (NAC) for the Treatment of 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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale Child Study Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 13 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / 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.
Other Names:
  • PharmaNAC
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OCD Severity at 12 Weeks
Time Frame: 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)
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Improvement at 12 Weeks
Time Frame: 12 weeks

Clinician Global Improvement Scale (CGI) 0=Not assessed 4=Moderately ill

  1. Normal, not at all ill 5=Markedly ill
  2. Borderline mentally ill 6=Severly ill
  3. Mildly ill 7=Very much worse
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Investigators

  • Principal Investigator: Michael H. Bloch, MD, MS, Yale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

February 13, 2017

Study Completion (Actual)

February 15, 2018

Study Registration Dates

First Submitted

July 27, 2010

First Submitted That Met QC Criteria

July 28, 2010

First Posted (Estimate)

July 29, 2010

Study Record Updates

Last Update Posted (Actual)

September 6, 2019

Last Update Submitted That Met QC Criteria

August 14, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1004006623

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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