Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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: Clinical Trial Phase 2 study, sponsored by Yale University.

NCT00539188 is a Phase 2 study that was terminated before completion, run by Yale University. The registered enrollment target is 6 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

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

Primary Outcome

The Self-Harm Inventory is assessed by asking an individual to answer (yes or no) if they have ever "intentionally, or on purpose" tried to harm themselves. The inventory contains 22 questions and a 23rd marked "other" that allows the individual to indicate a self-harm behavior not previously mentioned. The scoring of this instrument is determined by counting the number of endorsed self-harm behaviors out of the possible twenty-three asked. The maximum score any individual may achieve for the S

Interventions

  • DRUG placebo
  • DRUG N-Acetylcysteine

Trial Details

FieldValue
Enrollment Target 6 participants
Start Date 2007-09
Est. Completion 2010-11
Phase Phase 2
Yale University

1,492 total trials

Why NCT00539188 stopped before completion

NCT00539188 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).

The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.

NCT00539188 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00539188's enrollment target sits among peer trials

6 1996th of 2000 higher than 1 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

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar registry start date

  • NCT05988463 · started 2027-01-01 · Phase 1

    Dose-Escalation Study of Artesunate Patients With IPF

  • NCT07219706 · started 2026-12-10 · NA

    Dietary Fiber and Time Restricted Eating

  • NCT02831335 · started 2026-12-01

    Technical Development of Multi-Parametric Renocerebral MRI

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

Source: ClinicalTrials.gov NCT00539188, the US trial registry maintained by the National Library of Medicine. NCT00539188 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.