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NCT01172275 · ClinicalTrials.gov registry record · Phase 2
N-acetylcysteine (NAC) for Pediatric Obsessive-Compulsive Disorder
A Phase 2 study, sponsored by Yale University.
- Completed
- Registry status
- Phase 2
- Development phase
- 11
- Enrollment target
NCT01172275: Completed Phase 2 study, sponsored by Yale University.
NCT01172275 is a Phase 2 study that has completed, run by Yale University. The registered enrollment target is 11 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01172275, a Phase 2 study, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 11 participants
- Enrollment target
Study 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.
Primary Outcome
Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) (0-7:Subclinical, 8-15: Mild, 16-23: Moderate, 24-31: Severe, 32-40: Extreme)
Interventions
- OTHER Placebo
- DRUG N-Acetylcysteine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2012-07 |
| Est. Completion | 2018-02-15 |
| Phase | Phase 2 |
What the finished NCT01172275 record still lists
NCT01172275 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01172275 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01172275 about?
NCT01172275 is a clinical study titled "N-acetylcysteine (NAC) for 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 wi...
What is the current status of trial NCT01172275?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 11 participants. The study started on 2012-07. Estimated completion is 2018-02-15.
What interventions are being tested in trial NCT01172275?
The interventions under investigation include: Placebo (OTHER), N-Acetylcysteine (DRUG).
Who is sponsoring clinical trial NCT01172275?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01172275's enrollment target sits among peer trials
11 1967th of 2000 higher than 33 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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