Trial · NCT00539188
N-Acetylcysteine in Adjunct to DBT for the Treatment of Self-Injurious Behavior in BPD
NCT00539188, Phase 2, Terminated, Yale University; results first posted 2013-03-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. N-Acetylcysteine in Adjunct to DBT for the Treatment of Self-Injurious Behavior in BPD. Trials, record NCT00539188. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00539188
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- N-Acetylcysteine in Adjunct to DBT for the Treatment of Self-Injurious Behavior in BPD
- NCT number
- NCT00539188
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 6 participants, actual
- Lead sponsor
- Yale University
- Conditions
- Borderline Personality Disorder, Self-Injurious Behavior
- Interventions
- N-Acetylcysteine, placebo
- First posted
- 2007-10-04
- Last updated
- 2020-04-15
- Results first posted
- 2013-03-06
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Self-Harm Inventory (SHI) Score at 6 Weeks | 6 weeks | 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 SHI is a 23. Any individual scoring 5 or greater is classified as suffering from BPD. In this study, scoring on the SHI was primarily used to assess improvement of self-harming symptoms and throughout the study by comparing participant ratings from baseline and week 6. Positive numbers indicate a decrease (i.e. participant indicated less self-harming behavior) and negative numbers indicate an increase in self-harming behaviors reported. |
| Primary | Self-Harm Inventory (SHI) Score at Baseline | Baseline | 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 SHI is a 23. Any individual scoring 5 or greater is classified as suffering from BPD. In this study, scoring on the SHI was primarily used to assess improvement of self-harming symptoms and throughout the study by comparing participant ratings from baseline and week 6. Positive numbers indicate a decrease (i.e. participant indicated less self-harming behavior) and negative numbers indicate an increase in self-harming behaviors reported. |
| Secondary | Hamilton Depression Rating Scale (HAM-D) at 6 Weeks | 6 weeks | The Hamilton Rating Scale for Depression is a multiple item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery. Administered by a clinician, The questionnaire is designed for adults and is used to rate the severity of the patients depression by asking their mood, feelings of guilt, insomnia, agitation, weight change, suicidal ideation, and somatic symptoms. The scale also allows the clinician to assess the patient's level of retardation, and insight into their depression. Highest possible score is 52. HAM-D Scoring 0-7 = Normal 8-13 = Mild Depression 14-18 = Moderate Depression 19-22 = Severed Depression ≥23 = Very Severe Depression In this study, Baseline ratings were compared to those of week 6 to assess each participants change in depression throughout the study. A negative value indicates an increase in depression (i.e. the individual felt more depressed) and a positive value indicates a decrease in depression. |
| Secondary | Hamilton Depression Rating Scale (HAM-D) at Baseline | Baseline | The Hamilton Rating Scale for Depression is a multiple item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery. Administered by a clinician, The questionnaire is designed for adults and is used to rate the severity of the patients depression by asking their mood, feelings of guilt, insomnia, agitation, weight change, suicidal ideation, and somatic symptoms. The scale also allows the clinician to assess the patient's level of retardation, and insight into their depression. Highest possible score is 52. HAM-D Scoring 0-7 = Normal 8-13 = Mild Depression 14-18 = Moderate Depression 19-22 = Severed Depression ≥23 = Very Severe Depression In this study, Baseline ratings were compared to those of week 6 to assess each participants change in depression throughout the study. A negative value indicates an increase in depression (i.e. the individual felt more depressed) and a positive value indicates a decrease in depression. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Self-Harm Inventory (SHI) Score at 6 Weeks | 6 weeks | units on a scale | NUMBER | |
| SECONDARY | Hamilton Depression Rating Scale (HAM-D) at 6 Weeks | 6 weeks | units on a scale | NUMBER | |
| PRIMARY | Self-Harm Inventory (SHI) Score at Baseline | Baseline | units on a scale | NUMBER | |
| SECONDARY | Hamilton Depression Rating Scale (HAM-D) at Baseline | Baseline | units on a scale | NUMBER |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Self-Harm Inventory (SHI) Score at 6 Weeks | N-Acetylcysteine | 5 | units on a scale | ||
| Self-Harm Inventory (SHI) Score at 6 Weeks | Placebo | 1 | units on a scale | ||
| Hamilton Depression Rating Scale (HAM-D) at 6 Weeks | N-Acetylcysteine | 28 | units on a scale | ||
| Hamilton Depression Rating Scale (HAM-D) at 6 Weeks | Placebo | 18 | units on a scale | ||
| Self-Harm Inventory (SHI) Score at Baseline | N-Acetylcysteine | 8 | units on a scale | ||
| Self-Harm Inventory (SHI) Score at Baseline | Placebo | 4 | units on a scale | ||
| Hamilton Depression Rating Scale (HAM-D) at Baseline | N-Acetylcysteine | 25 | units on a scale | ||
| Hamilton Depression Rating Scale (HAM-D) at Baseline | Placebo | 27 | units on a scale |
Source ClinicalTrials.gov
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | N-Acetylcysteine | 4 | |
| Overall Study | STARTED | Placebo | 2 | |
| Overall Study | Received Allocated Intervention | N-Acetylcysteine | 3 | |
| Overall Study | Received Allocated Intervention | Placebo | 2 | |
| Overall Study | COMPLETED | N-Acetylcysteine | 1 | |
| Overall Study | COMPLETED | Placebo | 1 | |
| Overall Study | NOT COMPLETED | N-Acetylcysteine | 3 | |
| Overall Study | NOT COMPLETED | Placebo | 1 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | N-Acetylcysteine | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | N-Acetylcysteine | 0 | 3 |
| Total, other adverse events | Placebo | 0 | 2 |
| Total, serious adverse events | N-Acetylcysteine | 0 | 3 |
| Total, serious adverse events | Placebo | 0 | 2 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| N-Acetylcysteine vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00539188
GET https://conductscience.org/api/trials/v1/NCT00539188/registered