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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 is a Phase 2 study that has completed, run by Yale University. The registered enrollment target is 11 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01172275
The ClinicalTrials.gov registry entry for NCT01172275 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01172275 reports 0 study locations.
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.
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