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N-Acetylcysteine for Pediatric Trichotillomania

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ClinicalTrials.gov Identifier: NCT00993265
Recruitment Status : Completed
First Posted : October 12, 2009
Results First Posted : July 25, 2014
Last Update Posted : July 25, 2014
Sponsor:
Collaborator:
Trichotillomania Learning Center
Information provided by (Responsible Party):
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 Trichotillomania
Hair Pulling
Interventions Drug: N-Acetylcysteine
Drug: Placebo
Enrollment 39
Recruitment Details  
Pre-assignment Details  
Arm/Group Title N-acetylcysteine (NAC) Placebo
Hide Arm/Group Description

Patients randomized to this arm will receive N-Acetylcysteine, at a standard dose titrated to 2400 mg. They will receive NAC in addition to the medication regimen they are on at enrollment.

N-Acetylcysteine: 2400 mg by mouth PO (1200 mg AM, 1200 mg PM), 12 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 by mouth in AM, 2 capsules by mouth PM, 12 weeks

Period Title: Overall Study
Started 20 19
Completed 16 19
Not Completed 4 0
Reason Not Completed
Adverse Event             1             0
Changed dose of concomitant drug             2             0
Non-compliant with study medication             1             0
Arm/Group Title N-acetylcysteine (NAC) Placebo Total
Hide Arm/Group Description

Patients randomized to this arm will receive N-Acetylcysteine, at a standard dose titrated to 2400 mg. They will receive NAC in addition to the medication regimen they are on at enrollment.

N-Acetylcysteine: 2400 mg by mouth PO (1200 mg AM, 1200 mg PM), 12 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 by mouth in AM, 2 capsules by mouth PM, 12 weeks

Total of all reporting groups
Overall Number of Baseline Participants 20 19 39
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 19 participants 39 participants
<=18 years
20
 100.0%
19
 100.0%
39
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 19 participants 39 participants
14  (2.4) 13.1  (3.1) 13.5  (2.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 19 participants 39 participants
Female
17
  85.0%
17
  89.5%
34
  87.2%
Male
3
  15.0%
2
  10.5%
5
  12.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants 19 participants 39 participants
20 19 39
Massachusetts General Hospital - Hairpulling Scale (MGH-HPS)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 20 participants 19 participants 39 participants
13.2  (5.3) 16.6  (4.8) 14.9  (5.3)
[1]
Measure Description: The Massachusetts General Hospital - Hairpulling Scale (MGH-HPS) is a 7-question scale that measures the severity of hair pulling. The scale ranges from 0-28. The higher the score, the more severe the hairpulling.
The Trichotillomania Scale for Children (TSC)-Child Report   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 20 participants 19 participants 39 participants
2.35  (.74) 2.52  (.85) 2.44  (.85)
[1]
Measure Description: The Trichotillomania Scale for Children (TSC) - Child Version assesses hair pulling severity, distress, and impairment in children. The scale is split into two sections (severity and distress/impairment), with 12 questions (5 severity and 7 distress/impairment). The severity score is summed from questions 1-5 and divided by 5. The distress/impairment score is summed from questions 6-12 and divided by 7. The total score is calculated by summing the severity score and the distress/impairment score. Scores range from 0-4. Higher total scores indicate greater severity/distress/impairment.
The Trichotillomania Scale for Children (TSC)-Parent Report   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 20 participants 19 participants 39 participants
2.20  (0.71) 2.32  (0.71) 2.26  (0.71)
[1]
Measure Description: The Trichotillomania Scale for Children (TSC) - Parent Version assesses hair pulling severity, distress, and impairment in children. The scale is split into two sections (severity and distress/impairment), with 12 questions (5 severity and 7 distress/impairment). The severity score is summed from questions 1-5 and divided by 5. The distress/impairment score is summed from questions 6-12 and divided by 7. The total score is calculated by summing the severity score and the distress/impairment score. Scores range from 0-4. Higher total scores indicate greater severity/distress/impairment.
The Milwaukee Inventory for Styles of Trichotillomania (MIST) - Child Version   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 20 participants 19 participants 39 participants
Baseline MIST-C Focused Pulling Subscale 94  (35.2) 90.8  (30.5) 92.4  (35.2)
Baseline MIST-C Automatic Pulling Subscale 12.10  (9.3) 16.26  (9.8) 14.18  (9.8)
[1]
Measure Description: The Milwaukee Inventory for Styles of Trichotillomania (MIST) - Child Version assesses "focused" pulling, hair pulling that occurs intentionally to relieve tension or distress, and "automatic" pulling, hair pulling that occurs outside of the child's attention. This scale contains 25 questions, 21 questions in the "focused" pulling subscale and 4 questions in the "automatic" pulling subscale. The scores range from 0-36 on the "automatic" pulling subscale and 0-189 on the "focused" pulling subscale. Higher scores on the subscales indicate more of the hair pulling is of that style.
Multidimensional Anxiety Scale for Children (MASC)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 20 participants 19 participants 39 participants
48.7  (19.0) 52.9  (18.6) 50.8  (19.0)
[1]
Measure Description: The Multidimensional Anxiety Scale for Children (MASC) assesses major dimensions of anxiety in children. The MASC contains 39 items rated on a scale of 0-3. Scores range from 0-117. The higher the score, the greater the anxiety.
The Children's Depression Inventory (CDI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 20 participants 19 participants 39 participants
12.4  (6.8) 10.8  (8.5) 11.6  (8.5)
[1]
Measure Description: The Children's Depression Inventory (CDI) assesses depressive symptoms in children. The assessment contains 27 items rated on a scale of 0-2, with scores ranging from 0-54. The higher the score, the more severe the depressive symptoms.
1.Primary Outcome
Title Massachusetts General Hospital Hair Pulling Scale (MGH-HPS)
Hide Description The Massachusetts General Hospital - Hairpulling Scale (MGH-HPS) is a 7-question scale that measures the severity of hair pulling. The scale ranges from 0-28. The higher the score, the more severe the hairpulling.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title N-acetylcysteine (NAC) Placebo
Hide Arm/Group Description:

Patients randomized to this arm will receive N-Acetylcysteine, at a standard dose titrated to 2400 mg. They will receive NAC in addition to the medication regimen they are on at enrollment.

N-Acetylcysteine: 2400 mg by mouth PO (1200 mg AM, 1200 mg PM), 12 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 by mouth in AM, 2 capsules by mouth PM, 12 weeks

Overall Number of Participants Analyzed 20 19
Mean (Standard Error)
Unit of Measure: units on a scale
10.70  (1.49) 13.53  (1.47)
2.Secondary Outcome
Title Trichotillomania Scale for Children - Child Version
Hide Description The Trichotillomania Scale for Children (TSC) - Child Version assesses hair pulling severity, distress, and impairment in children. The scale is split into two sections (severity and distress/impairment), with 12 questions (5 severity and 7 distress/impairment). The severity score is summed from questions 1-5 and divided by 5. The distress/impairment score is summed from questions 6-12 and divided by 7. The total score is calculated by summing the severity score and the distress/impairment score. Scores range from 0-4. Higher total scores indicate greater severity/distress/impairment.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title N-acetylcysteine (NAC) Placebo
Hide Arm/Group Description:

Patients randomized to this arm will receive N-Acetylcysteine, at a standard dose titrated to 2400 mg. They will receive NAC in addition to the medication regimen they are on at enrollment.

N-Acetylcysteine: 2400 mg by mouth PO (1200 mg AM, 1200 mg PM), 12 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 by mouth in AM, 2 capsules by mouth PM, 12 weeks

Overall Number of Participants Analyzed 20 19
Mean (Standard Error)
Unit of Measure: units on a scale
2.00  (0.22) 2.08  (0.22)
3.Secondary Outcome
Title Multidimensional Anxiety Scale for Children (MASC)
Hide Description The Multidimensional Anxiety Scale for Children (MASC) assesses major dimensions of anxiety in children. The MASC contains 39 items rated on a scale of 0-3. Scores range from 0-117. The higher the score, the greater the anxiety.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title N-acetylcysteine (NAC) Placebo
Hide Arm/Group Description:

Patients randomized to this arm will receive N-Acetylcysteine, at a standard dose titrated to 2400 mg. They will receive NAC in addition to the medication regimen they are on at enrollment.

N-Acetylcysteine: 2400 mg by mouth PO (1200 mg AM, 1200 mg PM), 12 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 by mouth in AM, 2 capsules by mouth PM, 12 weeks

Overall Number of Participants Analyzed 20 19
Mean (Standard Error)
Unit of Measure: units on a scale
48.4  (4.3) 49.8  (4.3)
4.Secondary Outcome
Title Children's Depression Inventory
Hide Description The Massachusetts General Hospital - Hairpulling Scale (MGH-HPS) is a 7-question scale that measures the severity of hair pulling. The scale ranges from 0-28. The higher the score, the more severe the hairpulling.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title N-acetylcysteine (NAC) Placebo
Hide Arm/Group Description:

Patients randomized to this arm will receive N-Acetylcysteine, at a standard dose titrated to 2400 mg. They will receive NAC in addition to the medication regimen they are on at enrollment.

N-Acetylcysteine: 2400 mg by mouth PO (1200 mg AM, 1200 mg PM), 12 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 by mouth in AM, 2 capsules by mouth PM, 12 weeks

Overall Number of Participants Analyzed 20 19
Mean (Standard Error)
Unit of Measure: units on a scale
10.9  (1.9) 7.8  (1.9)
5.Secondary Outcome
Title Trichotillomania Scale for Children - Parent Version
Hide Description The Trichotillomania Scale for Children (TSC) - Parent Version assesses hair pulling severity, distress, and impairment in children. The scale is split into two sections (severity and distress/impairment), with 12 questions (5 severity and 7 distress/impairment). The severity score is summed from questions 1-5 and divided by 5. The distress/impairment score is summed from questions 6-12 and divided by 7. The total score is calculated by summing the severity score and the distress/impairment score. Scores range from 0-4. Higher total scores indicate greater severity/distress/impairment.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title N-acetylcysteine (NAC) Placebo
Hide Arm/Group Description:

Patients randomized to this arm will receive N-Acetylcysteine, at a standard dose titrated to 2400 mg. They will receive NAC in addition to the medication regimen they are on at enrollment.

N-Acetylcysteine: 2400 mg by mouth PO (1200 mg AM, 1200 mg PM), 12 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 by mouth in AM, 2 capsules by mouth PM, 12 weeks

Overall Number of Participants Analyzed 20 19
Mean (Standard Error)
Unit of Measure: units on a scale
1.83  (0.18) 1.88  (0.18)
6.Secondary Outcome
Title The Milwaukee Inventory for Styles of Trichotillomania–Child Version
Hide Description The Milwaukee Inventory for Styles of Trichotillomania (MIST) - Child Version assesses "focused" pulling, hair pulling that occurs intentionally to relieve tension or distress, and "automatic" pulling, hair pulling that occurs outside of the child's attention. This scale contains 25 questions, 21 questions in the "focused" pulling subscale and 4 questions in the "automatic" pulling subscale. The scores range from 0-36 on the "automatic" pulling subscale and 0-189 on the "focused" pulling subscale. Higher scores on the subscales indicate more of the hair pulling is of that style.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title N-acetylcysteine (NAC) Placebo
Hide Arm/Group Description:

Patients randomized to this arm will receive N-Acetylcysteine, at a standard dose titrated to 2400 mg. They will receive NAC in addition to the medication regimen they are on at enrollment.

N-Acetylcysteine: 2400 mg by mouth PO (1200 mg AM, 1200 mg PM), 12 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 by mouth in AM, 2 capsules by mouth PM, 12 weeks

Overall Number of Participants Analyzed 20 19
Mean (Standard Error)
Unit of Measure: units on a scale
Week 12 MIST-C "Automatic" Subscale 13.24  (1.98) 13.16  (1.96)
Week 12 MIST-C "Focused" Subscale 90.8  (8.1) 79.6  (8.1)
7.Secondary Outcome
Title National Institute of Mental Health –Trichotillomania Severity Scale (NIMH-TSS)
Hide Description The National Institute of Mental Health - Trichotillomania Severity Scale (NIMH-TSS) assesses severity of hair pulling. The NIMH-TSS is a 6 item assessment, with total scores ranging from 0-20. Higher scores indicate greater severity/impairment.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title N-acetylcysteine (NAC) Placebo
Hide Arm/Group Description:

Patients randomized to this arm will receive N-Acetylcysteine, at a standard dose titrated to 2400 mg. They will receive NAC in addition to the medication regimen they are on at enrollment.

N-Acetylcysteine: 2400 mg by mouth PO (1200 mg AM, 1200 mg PM), 12 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 by mouth in AM, 2 capsules by mouth PM, 12 weeks

Overall Number of Participants Analyzed 20 19
Mean (Standard Error)
Unit of Measure: units on a scale
9.56  (0.71) 10.89  (1.24)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title N-acetylcysteine (NAC) Placebo
Hide Arm/Group Description

Patients randomized to this arm will receive N-Acetylcysteine, at a standard dose titrated to 2400 mg. They will receive NAC in addition to the medication regimen they are on at enrollment.

N-Acetylcysteine: 2400 mg by mouth PO (1200 mg AM, 1200 mg PM), 12 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 by mouth in AM, 2 capsules by mouth PM, 12 weeks

All-Cause Mortality
N-acetylcysteine (NAC) Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
N-acetylcysteine (NAC) Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/19 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
N-acetylcysteine (NAC) Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   6/20 (30.00%)   12/19 (63.16%) 
Gastrointestinal disorders     
Nausea   6/20 (30.00%)  12/19 (63.16%) 
Diarrhea   1/20 (5.00%)  1/19 (5.26%) 
General disorders     
Fatigue   0/20 (0.00%)  2/19 (10.53%) 
Insomnia   0/20 (0.00%)  1/19 (5.26%) 
Difficulty Swallowing Pills   2/20 (10.00%)  1/19 (5.26%) 
Psychiatric disorders     
Depression   1/20 (5.00%)  0/19 (0.00%) 
Skin and subcutaneous tissue disorders     
Rash   1/20 (5.00%)  0/19 (0.00%) 
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Michael Bloch, MD, MS
Organization: Yale University, Child Study Center
Phone: 203-737-4809
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00993265     History of Changes
Other Study ID Numbers: 0906005337
NACPEDTTM
First Submitted: October 9, 2009
First Posted: October 12, 2009
Results First Submitted: March 7, 2014
Results First Posted: July 25, 2014
Last Update Posted: July 25, 2014