Trial Outcomes & Findings for N-Acetylcysteine for Pediatric Trichotillomania (NCT NCT00993265)
NCT ID: NCT00993265
Last Updated: 2014-07-25
Results Overview
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.
COMPLETED
PHASE2
39 participants
Week 12
2014-07-25
Participant Flow
Participant milestones
| Measure |
N-acetylcysteine (NAC)
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
|
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 by mouth in AM, 2 capsules by mouth PM, 12 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
19
|
|
Overall Study
COMPLETED
|
16
|
19
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
Reasons for withdrawal
| Measure |
N-acetylcysteine (NAC)
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
|
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 by mouth in AM, 2 capsules by mouth PM, 12 weeks
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Changed dose of concomitant drug
|
2
|
0
|
|
Overall Study
Non-compliant with study medication
|
1
|
0
|
Baseline Characteristics
N-Acetylcysteine for Pediatric Trichotillomania
Baseline characteristics by cohort
| Measure |
N-acetylcysteine (NAC)
n=20 Participants
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
|
Placebo
n=19 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 by mouth in AM, 2 capsules by mouth PM, 12 weeks
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
20 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
39 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Continuous
|
14 years
STANDARD_DEVIATION 2.4 • n=93 Participants
|
13.1 years
STANDARD_DEVIATION 3.1 • n=4 Participants
|
13.5 years
STANDARD_DEVIATION 2.8 • n=27 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
34 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=93 Participants
|
19 participants
n=4 Participants
|
39 participants
n=27 Participants
|
|
Massachusetts General Hospital - Hairpulling Scale (MGH-HPS)
|
13.2 units on a scale
STANDARD_DEVIATION 5.3 • n=93 Participants
|
16.6 units on a scale
STANDARD_DEVIATION 4.8 • n=4 Participants
|
14.9 units on a scale
STANDARD_DEVIATION 5.3 • n=27 Participants
|
|
The Trichotillomania Scale for Children (TSC)-Child Report
|
2.35 units on a scale
STANDARD_DEVIATION .74 • n=93 Participants
|
2.52 units on a scale
STANDARD_DEVIATION .85 • n=4 Participants
|
2.44 units on a scale
STANDARD_DEVIATION .85 • n=27 Participants
|
|
The Trichotillomania Scale for Children (TSC)-Parent Report
|
2.20 units on a scale
STANDARD_DEVIATION 0.71 • n=93 Participants
|
2.32 units on a scale
STANDARD_DEVIATION 0.71 • n=4 Participants
|
2.26 units on a scale
STANDARD_DEVIATION 0.71 • n=27 Participants
|
|
The Milwaukee Inventory for Styles of Trichotillomania (MIST) - Child Version
Baseline MIST-C Focused Pulling Subscale
|
94 units on a scale
STANDARD_DEVIATION 35.2 • n=93 Participants
|
90.8 units on a scale
STANDARD_DEVIATION 30.5 • n=4 Participants
|
92.4 units on a scale
STANDARD_DEVIATION 35.2 • n=27 Participants
|
|
The Milwaukee Inventory for Styles of Trichotillomania (MIST) - Child Version
Baseline MIST-C Automatic Pulling Subscale
|
12.10 units on a scale
STANDARD_DEVIATION 9.3 • n=93 Participants
|
16.26 units on a scale
STANDARD_DEVIATION 9.8 • n=4 Participants
|
14.18 units on a scale
STANDARD_DEVIATION 9.8 • n=27 Participants
|
|
Multidimensional Anxiety Scale for Children (MASC)
|
48.7 units on a scale
STANDARD_DEVIATION 19.0 • n=93 Participants
|
52.9 units on a scale
STANDARD_DEVIATION 18.6 • n=4 Participants
|
50.8 units on a scale
STANDARD_DEVIATION 19.0 • n=27 Participants
|
|
The Children's Depression Inventory (CDI)
|
12.4 units on a scale
STANDARD_DEVIATION 6.8 • n=93 Participants
|
10.8 units on a scale
STANDARD_DEVIATION 8.5 • n=4 Participants
|
11.6 units on a scale
STANDARD_DEVIATION 8.5 • n=27 Participants
|
PRIMARY outcome
Timeframe: Week 12The 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.
Outcome measures
| Measure |
N-acetylcysteine (NAC)
n=20 Participants
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
|
Placebo
n=19 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 by mouth in AM, 2 capsules by mouth PM, 12 weeks
|
|---|---|---|
|
Massachusetts General Hospital Hair Pulling Scale (MGH-HPS)
|
10.70 units on a scale
Standard Error 1.49
|
13.53 units on a scale
Standard Error 1.47
|
SECONDARY outcome
Timeframe: Week 12The 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.
Outcome measures
| Measure |
N-acetylcysteine (NAC)
n=20 Participants
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
|
Placebo
n=19 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 by mouth in AM, 2 capsules by mouth PM, 12 weeks
|
|---|---|---|
|
Trichotillomania Scale for Children - Child Version
|
2.00 units on a scale
Standard Error 0.22
|
2.08 units on a scale
Standard Error 0.22
|
SECONDARY outcome
Timeframe: Week 12The 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.
Outcome measures
| Measure |
N-acetylcysteine (NAC)
n=20 Participants
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
|
Placebo
n=19 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 by mouth in AM, 2 capsules by mouth PM, 12 weeks
|
|---|---|---|
|
Multidimensional Anxiety Scale for Children (MASC)
|
48.4 units on a scale
Standard Error 4.3
|
49.8 units on a scale
Standard Error 4.3
|
SECONDARY outcome
Timeframe: Week 12The 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.
Outcome measures
| Measure |
N-acetylcysteine (NAC)
n=20 Participants
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
|
Placebo
n=19 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 by mouth in AM, 2 capsules by mouth PM, 12 weeks
|
|---|---|---|
|
Children's Depression Inventory
|
10.9 units on a scale
Standard Error 1.9
|
7.8 units on a scale
Standard Error 1.9
|
SECONDARY outcome
Timeframe: Week 12The 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.
Outcome measures
| Measure |
N-acetylcysteine (NAC)
n=20 Participants
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
|
Placebo
n=19 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 by mouth in AM, 2 capsules by mouth PM, 12 weeks
|
|---|---|---|
|
Trichotillomania Scale for Children - Parent Version
|
1.83 units on a scale
Standard Error 0.18
|
1.88 units on a scale
Standard Error 0.18
|
SECONDARY outcome
Timeframe: Week 12The 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.
Outcome measures
| Measure |
N-acetylcysteine (NAC)
n=20 Participants
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
|
Placebo
n=19 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 by mouth in AM, 2 capsules by mouth PM, 12 weeks
|
|---|---|---|
|
The Milwaukee Inventory for Styles of Trichotillomania-Child Version
Week 12 MIST-C "Automatic" Subscale
|
13.24 units on a scale
Standard Error 1.98
|
13.16 units on a scale
Standard Error 1.96
|
|
The Milwaukee Inventory for Styles of Trichotillomania-Child Version
Week 12 MIST-C "Focused" Subscale
|
90.8 units on a scale
Standard Error 8.1
|
79.6 units on a scale
Standard Error 8.1
|
SECONDARY outcome
Timeframe: Week 12The 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.
Outcome measures
| Measure |
N-acetylcysteine (NAC)
n=20 Participants
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
|
Placebo
n=19 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 by mouth in AM, 2 capsules by mouth PM, 12 weeks
|
|---|---|---|
|
National Institute of Mental Health -Trichotillomania Severity Scale (NIMH-TSS)
|
9.56 units on a scale
Standard Error 0.71
|
10.89 units on a scale
Standard Error 1.24
|
Adverse Events
N-acetylcysteine (NAC)
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
N-acetylcysteine (NAC)
n=20 participants at risk
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
|
Placebo
n=19 participants at risk
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
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
30.0%
6/20
|
63.2%
12/19
|
|
Gastrointestinal disorders
Diarrhea
|
5.0%
1/20
|
5.3%
1/19
|
|
General disorders
Fatigue
|
0.00%
0/20
|
10.5%
2/19
|
|
General disorders
Insomnia
|
0.00%
0/20
|
5.3%
1/19
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.0%
1/20
|
0.00%
0/19
|
|
Psychiatric disorders
Depression
|
5.0%
1/20
|
0.00%
0/19
|
|
General disorders
Difficulty Swallowing Pills
|
10.0%
2/20
|
5.3%
1/19
|
Additional Information
Dr. Michael Bloch, MD, MS
Yale University, Child Study Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place