N-acetylcysteine (NAC) for Pediatric Obsessive-Compulsive Disorder
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|ClinicalTrials.gov Identifier: NCT01172275|
Recruitment Status : Active, not recruiting
First Posted : July 29, 2010
Last Update Posted : January 13, 2017
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 or disease||Intervention/treatment||Phase|
|Obsessive-Compulsive Disorder||Drug: N-Acetylcysteine Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Double-Blind, Placebo-Controlled Trial of N-acetylcysteine (NAC) for the Treatment of Pediatric Obsessive-Compulsive Disorder|
|Study Start Date :||July 2012|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2017|
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.
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.
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.
- Improvement in OCD Severity [ Time Frame: 12 weeks ]Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS)
- Improvement in OCD Symptom Dimensions [ Time Frame: 12 weeks ]Dimensional Yale-Brown Obsessive-Compulsive Scale (DY-BOCS)
- Overall Improvement [ Time Frame: 12 weeks ]Clinician Global Improvement Scale (CGI)
- Adverse Effects [ Time Frame: 12 weeks ]Pediatric Adverse Events Rating Scale (PAERS)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01172275
|United States, Connecticut|
|Yale Child Study Center|
|New Haven, Connecticut, United States, 06520|
|Principal Investigator:||Michael H. Bloch, MD, MS||Yale University|