N-Acetylcysteine for Pediatric Trichotillomania

• Sponsor: Yale University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00993265
• Collaborator: Trichotillomania Learning Center (Other)
• Enrollment: 39
• Location: 1
• Arms: 2
• Duration (Months): 53
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

Trichotillomania (hair pulling) has an estimated lifetime prevalence of 1-3%. Children with trichotillomania can experience significant impairment due to peer teasing, avoidance of activities (such as swimming and socializing), difficulty concentrating on school work and medical complications due to pulling behaviors. Despite the fact that trichotillomania has a childhood onset, no randomized, controlled trials have been completed in childhood trichotillomania.

Research in adults with trichotillomania has demonstrated that most commonly currently prescribed treatment for trichotillomania, (pharmacotherapy with selective serotonin reuptake inhibitors) is ineffective in treating this condition. By contrast, randomized controlled trials in adults have suggested the efficacy of N-acetylcysteine as well as behavioral treatments such as Habit Reversal Therapy.

The goal of this trial is to determine the efficacy of N-Acetylcysteine for pediatric trichotillomania. N-Acetylcysteine is a glutamate modulating agent, with a fairly benign side-effect profile.

Condition or Disease	Intervention/Treatment	Phase
Trichotillomania; Hair Pulling	Drug: N-Acetylcysteine; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 39 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Double-Blind, Placebo-Controlled Trial of N-acetylcysteine for the Treatment of Pediatric Trichotillomania
• Study Start Date: Oct 1, 2009
• Actual Primary Completion Date: Apr 1, 2012
• Actual Study Completion Date: Mar 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: N-Acetylcysteine; 2400 mg by mouth PO (1200 mg AM, 1200 mg PM), 12 weeks
Placebo Comparator: 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.	Drug: Placebo; placebo, 2 capsules by mouth in AM, 2 capsules by mouth PM, 12 weeks

Outcome Measures

Primary Outcome Measures

1. Massachusetts General Hospital Hair Pulling Scale (MGH-HPS) [Week 12]

   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.

Secondary Outcome Measures

1. Trichotillomania Scale for Children - Child Version [Week 12]

   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.

2. Multidimensional Anxiety Scale for Children (MASC) [Week 12]

   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.

3. Children's Depression Inventory [Week 12]

   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.

4. Trichotillomania Scale for Children - Parent Version [Week 12]

   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.

5. The Milwaukee Inventory for Styles of Trichotillomania-Child Version [Week 12]

   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.

6. National Institute of Mental Health -Trichotillomania Severity Scale (NIMH-TSS) [Week 12]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 8 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Children aged 8-17 years.

• Primary DSM-IV diagnosis of trichotillomania or chronic hair pulling.

• Duration of trichotillomania greater than 6 months.

Exclusion Criteria:

• Comorbid bipolar disorder, psychotic disorder, substance use disorder, developmental disorder or mental retardation (IQ<70).

• Recent change (less than 4 weeks) in medications that have potential effects on TTM severity (such as SSRIs, CMI, naltrexone, lithium, psychostimulants, anxiolytics, or antipsychotics). Medication change is defined to include either dose changes or medication discontinuation.

• Asthma requiring medication use within the last 6 months.

• Known hypersensitivity or previous anaphylactoid reaction to acetylcysteine or any components in its preparation

• Current use (within last week) of psychostimulant medications.

• Positive pregnancy test or drug screening test

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yale Child Study Center	New Haven	Connecticut	United States	06520

Sponsors and Collaborators

• Yale University
• Trichotillomania Learning Center

Investigators

• Principal Investigator: Michael H. Bloch, M.D., M.S., Yale University

Study Documents (Full-Text)

None provided.

More Information

Publications

• Bloch MH. Trichotillomania across the life span. J Am Acad Child Adolesc Psychiatry. 2009 Sep;48(9):879-883. doi: 10.1097/CHI.0b013e3181ae09f3. Review.
• Grant JE, Odlaug BL, Kim SW. N-acetylcysteine, a glutamate modulator, in the treatment of trichotillomania: a double-blind, placebo-controlled study. Arch Gen Psychiatry. 2009 Jul;66(7):756-63. doi: 10.1001/archgenpsychiatry.2009.60.

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT00993265
• Other Study ID Numbers: 0906005337; NACPEDTTM
• First Posted: Oct 12, 2009
• Last Update Posted: Jul 25, 2014
• Last Verified: Jun 1, 2014

• Keywords provided by Yale University: Trichotillomania; Hair pulling; glutamate; N-Acetylcysteine; Children
• Additional relevant MeSH terms: Trichotillomania; Acetylcysteine; N-monoacetylcystine

Study Results

Participant Flow

Arm/Group Title	N-acetylcysteine (NAC)	Placebo
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

Baseline Characteristics

Arm/Group Title	N-acetylcysteine (NAC)	Placebo	Total
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 Participants	20	19	39
Age (Count of Participants)
<=18 years	20 100%	19 100%	39 100%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	14 (2.4)	13.1 (3.1)	13.5 (2.8)
Sex: Female, Male (Count of Participants)
Female	17 85%	17 89.5%	34 87.2%
Male	3 15%	2 10.5%	5 12.8%
Region of Enrollment (participants) [Number]
United States	20 100%	19 100%	39 100%
Massachusetts General Hospital - Hairpulling Scale (MGH-HPS) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	13.2 (5.3)	16.6 (4.8)	14.9 (5.3)
The Trichotillomania Scale for Children (TSC)-Child Report (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	2.35 (.74)	2.52 (.85)	2.44 (.85)
The Trichotillomania Scale for Children (TSC)-Parent Report (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	2.20 (0.71)	2.32 (0.71)	2.26 (0.71)
The Milwaukee Inventory for Styles of Trichotillomania (MIST) - Child Version (units on a scale) [Mean (Standard Deviation) ]
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)
Multidimensional Anxiety Scale for Children (MASC) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	48.7 (19.0)	52.9 (18.6)	50.8 (19.0)
The Children's Depression Inventory (CDI) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	12.4 (6.8)	10.8 (8.5)	11.6 (8.5)

Outcome Measures

1. Primary Outcome

Title	Massachusetts General Hospital Hair Pulling Scale (MGH-HPS)
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	N-acetylcysteine (NAC)	Placebo
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
Measure Participants	20	19
Mean (Standard Error) [units on a scale]	10.70 (1.49)	13.53 (1.47)

2. Secondary Outcome

Title	Trichotillomania Scale for Children - Child Version
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	N-acetylcysteine (NAC)	Placebo
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
Measure Participants	20	19
Mean (Standard Error) [units on a scale]	2.00 (0.22)	2.08 (0.22)

3. Secondary Outcome

Title	Multidimensional Anxiety Scale for Children (MASC)
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	N-acetylcysteine (NAC)	Placebo
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
Measure Participants	20	19
Mean (Standard Error) [units on a scale]	48.4 (4.3)	49.8 (4.3)

4. Secondary Outcome

Title	Children's Depression Inventory
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	N-acetylcysteine (NAC)	Placebo
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
Measure Participants	20	19
Mean (Standard Error) [units on a scale]	10.9 (1.9)	7.8 (1.9)

5. Secondary Outcome

Title	Trichotillomania Scale for Children - Parent Version
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	N-acetylcysteine (NAC)	Placebo
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
Measure Participants	20	19
Mean (Standard Error) [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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	N-acetylcysteine (NAC)	Placebo
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
Measure Participants	20	19
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)
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	N-acetylcysteine (NAC)	Placebo
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
Measure Participants	20	19
Mean (Standard Error) [units on a scale]	9.56 (0.71)	10.89 (1.24)

Adverse Events

Arm/Group Title	N-acetylcysteine (NAC)		Placebo
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	N-acetylcysteine (NAC)		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/19 (0%)
Other (Not Including Serious) Adverse Events
	N-acetylcysteine (NAC)		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/20 (30%)		12/19 (63.2%)
Gastrointestinal disorders
Nausea	6/20 (30%)		12/19 (63.2%)
Diarrhea	1/20 (5%)		1/19 (5.3%)
General disorders
Fatigue	0/20 (0%)		2/19 (10.5%)
Insomnia	0/20 (0%)		1/19 (5.3%)
Difficulty Swallowing Pills	2/20 (10%)		1/19 (5.3%)
Psychiatric disorders
Depression	1/20 (5%)		0/19 (0%)
Skin and subcutaneous tissue disorders
Rash	1/20 (5%)		0/19 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.