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N-Acetylcysteine in Adjunct to DBT for the Treatment of Self-Injurious Behavior in BPD

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ClinicalTrials.gov Identifier: NCT00539188
Recruitment Status : Terminated (Study terminated due to poor subject compliance.)
First Posted : October 4, 2007
Results First Posted : March 6, 2013
Last Update Posted : April 1, 2013
Sponsor:
Information provided by (Responsible Party):
Christopher Pittenger, Yale University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Borderline Personality Disorder
Self-Injurious Behavior
Interventions Drug: N-Acetylcysteine
Drug: placebo
Enrollment 6
Recruitment Details  
Pre-assignment Details  
Arm/Group Title N-Acetylcysteine Placebo
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started 4 2
Received Allocated Intervention 3 2
Completed 1 1
Not Completed 3 1
Reason Not Completed
Withdrawal by Subject             1             0
Lost to Follow-up             2             1
Arm/Group Title N-Acetylcysteine Placebo Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 4 2 6
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 2 participants 6 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
4
 100.0%
2
 100.0%
6
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 2 participants 6 participants
Female
3
  75.0%
1
  50.0%
4
  66.7%
Male
1
  25.0%
1
  50.0%
2
  33.3%
1.Primary Outcome
Title Self-Harm Inventory (SHI) Score at 6 Weeks
Hide Description

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.

Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title N-Acetylcysteine Placebo
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 1 1
Measure Type: Number
Unit of Measure: units on a scale
5 1
2.Primary Outcome
Title Self-Harm Inventory (SHI) Score at Baseline
Hide Description

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.

Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title N-Acetylcysteine Placebo
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 1 1
Measure Type: Number
Unit of Measure: units on a scale
8 4
3.Secondary Outcome
Title Hamilton Depression Rating Scale (HAM-D) at 6 Weeks
Hide Description

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.

Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title N-Acetylcysteine Placebo
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 1 1
Measure Type: Number
Unit of Measure: units on a scale
28 18
4.Secondary Outcome
Title Hamilton Depression Rating Scale (HAM-D) at Baseline
Hide Description

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.

Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title N-Acetylcysteine Placebo
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 1 1
Measure Type: Number
Unit of Measure: units on a scale
25 27
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title N-Acetylcysteine Placebo
Hide Arm/Group Description

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

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

All-Cause Mortality
N-Acetylcysteine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
N-Acetylcysteine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   0/2 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
N-Acetylcysteine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   0/2 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Christopher Pittenger, MD Ph.D
Organization: Yale University School of Medicine
Phone: 203-974-7675
EMail: christopher.pittenger@yale.edu
Layout table for additonal information
Responsible Party: Christopher Pittenger, Yale University
ClinicalTrials.gov Identifier: NCT00539188     History of Changes
Other Study ID Numbers: YOCD-3
First Submitted: October 2, 2007
First Posted: October 4, 2007
Results First Submitted: December 21, 2012
Results First Posted: March 6, 2013
Last Update Posted: April 1, 2013