Trial Outcomes & Findings for N-Acetylcysteine in Adjunct to DBT for the Treatment of Self-Injurious Behavior in BPD (NCT NCT00539188)
NCT ID: NCT00539188
Last Updated: 2020-04-15
Results Overview
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.
TERMINATED
PHASE2
6 participants
6 weeks
2020-04-15
Participant Flow
Participant milestones
| Measure |
N-Acetylcysteine
Patients randomized to this arm will receive N-Acetylcysteine augmentation, at a standard dose (3000 mg daily), in addition to the medication regimen they are on at enrollment
N-Acetylcysteine : 3000 mg PO (1200 mg AM, 1800 mg PM), 6 weeks
|
Placebo
Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.
placebo : placebo, 2 capsules PO AM, 3 capsules PO PM, 6 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
2
|
|
Overall Study
Received Allocated Intervention
|
3
|
2
|
|
Overall Study
COMPLETED
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
N-Acetylcysteine
Patients randomized to this arm will receive N-Acetylcysteine augmentation, at a standard dose (3000 mg daily), in addition to the medication regimen they are on at enrollment
N-Acetylcysteine : 3000 mg PO (1200 mg AM, 1800 mg PM), 6 weeks
|
Placebo
Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.
placebo : placebo, 2 capsules PO AM, 3 capsules PO PM, 6 weeks
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
Baseline Characteristics
N-Acetylcysteine in Adjunct to DBT for the Treatment of Self-Injurious Behavior in BPD
Baseline characteristics by cohort
| Measure |
N-Acetylcysteine
n=4 Participants
Patients randomized to this arm will receive N-Acetylcysteine augmentation, at a standard dose (3000 mg daily), in addition to the medication regimen they are on at enrollment
N-Acetylcysteine : 3000 mg PO (1200 mg AM, 1800 mg PM), 6 weeks
|
Placebo
n=2 Participants
Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.
placebo : placebo, 2 capsules PO AM, 3 capsules PO PM, 6 weeks
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeksThe 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.
Outcome measures
| Measure |
N-Acetylcysteine
n=1 Participants
Patients randomized to this arm will receive N-Acetylcysteine augmentation, at a standard dose (3000 mg daily), in addition to the medication regimen they are on at enrollment
N-Acetylcysteine : 3000 mg PO (1200 mg AM, 1800 mg PM), 6 weeks
|
Placebo
n=1 Participants
Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.
placebo : placebo, 2 capsules PO AM, 3 capsules PO PM, 6 weeks
|
|---|---|---|
|
Self-Harm Inventory (SHI) Score at 6 Weeks
|
5 units on a scale
|
1 units on a scale
|
PRIMARY outcome
Timeframe: BaselineThe 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.
Outcome measures
| Measure |
N-Acetylcysteine
n=1 Participants
Patients randomized to this arm will receive N-Acetylcysteine augmentation, at a standard dose (3000 mg daily), in addition to the medication regimen they are on at enrollment
N-Acetylcysteine : 3000 mg PO (1200 mg AM, 1800 mg PM), 6 weeks
|
Placebo
n=1 Participants
Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.
placebo : placebo, 2 capsules PO AM, 3 capsules PO PM, 6 weeks
|
|---|---|---|
|
Self-Harm Inventory (SHI) Score at Baseline
|
8 units on a scale
|
4 units on a scale
|
SECONDARY outcome
Timeframe: 6 weeksThe 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.
Outcome measures
| Measure |
N-Acetylcysteine
n=1 Participants
Patients randomized to this arm will receive N-Acetylcysteine augmentation, at a standard dose (3000 mg daily), in addition to the medication regimen they are on at enrollment
N-Acetylcysteine : 3000 mg PO (1200 mg AM, 1800 mg PM), 6 weeks
|
Placebo
n=1 Participants
Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.
placebo : placebo, 2 capsules PO AM, 3 capsules PO PM, 6 weeks
|
|---|---|---|
|
Hamilton Depression Rating Scale (HAM-D) at 6 Weeks
|
28 units on a scale
|
18 units on a scale
|
SECONDARY outcome
Timeframe: BaselineThe 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.
Outcome measures
| Measure |
N-Acetylcysteine
n=1 Participants
Patients randomized to this arm will receive N-Acetylcysteine augmentation, at a standard dose (3000 mg daily), in addition to the medication regimen they are on at enrollment
N-Acetylcysteine : 3000 mg PO (1200 mg AM, 1800 mg PM), 6 weeks
|
Placebo
n=1 Participants
Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.
placebo : placebo, 2 capsules PO AM, 3 capsules PO PM, 6 weeks
|
|---|---|---|
|
Hamilton Depression Rating Scale (HAM-D) at Baseline
|
25 units on a scale
|
27 units on a scale
|
Adverse Events
N-Acetylcysteine
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Christopher Pittenger, MD Ph.D
Yale University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place