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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Yale University
Sponsor:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01172275
First received: July 27, 2010
Last updated: July 29, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Obsessive-Compulsive Disorder
Drug: N-Acetylcysteine
Drug: Placebo
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Improvement in OCD Severity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS)


Secondary Outcome Measures:
  • 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)


Estimated Enrollment: 40
Study Start Date: July 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: 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

Ages Eligible for Study:   8 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01172275

Contacts
Contact: Catherine Coughlin, BS (203) 737-4809 Catherine.coughlin@yale.edu
Contact: Michael H. Bloch, MD, MS (203) 974-7551 michael.bloch@yale.edu

Locations
United States, Connecticut
Yale Child Study Center Recruiting
New Haven, Connecticut, United States, 06520
Contact: Catherine Coughlin, BS    203-737-4809    catherine.coughlin@yale.edu   
Principal Investigator: Michael H Bloch, MD         
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Michael H. Bloch, MD, MS Yale University
  More Information

Additional Information:
Publications:
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01172275     History of Changes
Other Study ID Numbers: YCSC1004006623
Study First Received: July 27, 2010
Last Updated: July 29, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
Obsessive-Compulsive Disorder
OCD

Additional relevant MeSH terms:
Obsessive-Compulsive Disorder
Compulsive Personality Disorder
Anxiety Disorders
Mental Disorders
Personality Disorders
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes

ClinicalTrials.gov processed this record on August 27, 2014