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NCT00539188 · ClinicalTrials.gov registry record · Phase 2
N-Acetylcysteine in Adjunct to DBT for the Treatment of Self-Injurious Behavior in BPD
A Phase 2 study, sponsored by Yale University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 6
- Enrollment target
NCT00539188 is a Phase 2 study that was terminated before completion, run by Yale University. The registered enrollment target is 6 participants.
The verdict
NCT00539188, a Phase 2 study, was terminated before completion, sponsored by Yale University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 6 participants
- Enrollment target
Study Summary
Self-Injurious Behavior (SIB) is a dangerous and common symptom in Borderline Personality Disorder (BPD) patients. Approximately 70% of patients with BPD engage in SIB at some point, compared to 17.5% of patients with other personality disorders. While SIB may prompt unnecessary psychiatric hospitalizations, it may also cause potential underestimation of the lethality of suicidal behavior, thus creating a major and confusing challenge in the practice of clinical psychiatry. Dialectical Behavioral Therapy (DBT) is a collection of therapeutic techniques focused on emotional regulation, impulse control, and improving safety in patients with BPD and others with marked self-destructive behavioral tendencies. Though DBT has marked ability to reduce BPD symptomatology, including SIB, improvement in SIB is limited and dependent on extensive therapy and time. Furthermore, the literature on the pharmacological treatment of SIB associated with BPD is scarce. Animal studies suggest that SIB may be associated with an imbalance between dopamine and glutamate in the brain. Anti-seizure medications that modulate glutamate transmission, such as lamotrigine and topiramate, have been suggested to be effective in the treatment of SIB in humans. Preliminary evidence suggests that antiglutamatergic medications may decrease SIB in patients with BPD. Early studies have focused on the antiglutamatergic drug riluzole. More recently, we have become interested in the amino acid N-acetylcysteine (NAC), which is used clinically for its antioxidant properties and is widely available as a nutritional supplement. Recent animal studies have suggested that NAC can modulate glutamate in the central nervous system in a way very similar to that proposed for riluzole, and indeed we have observed NAC to have an effect similar to riluzole in a case of treatment-refractory obsessive-compulsive disorder. This study will be a double-blind, randomized, and placebo-controlled evaluation of N-Acetylcysteine
Interventions
- DRUG placebo
- DRUG N-Acetylcysteine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2007-09 |
| Est. Completion | 2010-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00539188
The ClinicalTrials.gov registry entry for NCT00539188 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 6 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.
NCT00539188 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00539188 about?
NCT00539188 is a clinical study titled "N-Acetylcysteine in Adjunct to DBT for the Treatment of Self-Injurious Behavior in BPD". Self-Injurious Behavior (SIB) is a dangerous and common symptom in Borderline Personality Disorder (BPD) patients. Approximately 70% of patients with BPD engage in SIB at some point, compared to 17.5% of patients with other personality disorders. While SIB may prompt unnecessary psychiatric hospital...
What is the current status of trial NCT00539188?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 6 participants. The study started on 2007-09. Estimated completion is 2010-11.
What interventions are being tested in trial NCT00539188?
The interventions under investigation include: placebo (DRUG), N-Acetylcysteine (DRUG).
Who is sponsoring clinical trial NCT00539188?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
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