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N-Acetylcysteine for Pediatric Trichotillomania

Primary Purpose

Trichotillomania, Hair Pulling

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
N-Acetylcysteine
Placebo
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trichotillomania focused on measuring Trichotillomania, Hair pulling, glutamate, N-Acetylcysteine, Children

Eligibility Criteria

8 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Yale Child Study Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

N-acetylcysteine (NAC)

Placebo

Arm 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.

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.

Outcomes

Primary Outcome Measures

Massachusetts General Hospital Hair Pulling Scale (MGH-HPS)
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

Trichotillomania Scale for Children - Child Version
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.
Multidimensional Anxiety Scale for Children (MASC)
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.
Children's Depression Inventory
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.
Trichotillomania Scale for Children - Parent Version
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-Child Version
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.
National Institute of Mental Health -Trichotillomania Severity Scale (NIMH-TSS)
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.

Full Information

First Posted
October 9, 2009
Last Updated
June 26, 2014
Sponsor
Yale University
Collaborators
Trichotillomania Learning Center
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1. Study Identification

Unique Protocol Identification Number
NCT00993265
Brief Title
N-Acetylcysteine for Pediatric Trichotillomania
Official Title
Double-Blind, Placebo-Controlled Trial of N-acetylcysteine for the Treatment of Pediatric Trichotillomania
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
Trichotillomania Learning Center

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trichotillomania, Hair Pulling
Keywords
Trichotillomania, Hair pulling, glutamate, N-Acetylcysteine, Children

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
N-acetylcysteine (NAC)
Arm Type
Experimental
Arm 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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
N-Acetylcysteine
Intervention Description
2400 mg by mouth PO (1200 mg AM, 1200 mg PM), 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo, 2 capsules by mouth in AM, 2 capsules by mouth PM, 12 weeks
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
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
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
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
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
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
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael H. Bloch, M.D., M.S.
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale Child Study Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19692854
Citation
Bloch MH. Trichotillomania across the life span. J Am Acad Child Adolesc Psychiatry. 2009 Sep;48(9):879-883. doi: 10.1097/CHI.0b013e3181ae09f3. No abstract available.
Results Reference
background
PubMed Identifier
19581567
Citation
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.
Results Reference
background
PubMed Identifier
34582562
Citation
Hoffman J, Williams T, Rothbart R, Ipser JC, Fineberg N, Chamberlain SR, Stein DJ. Pharmacotherapy for trichotillomania. Cochrane Database Syst Rev. 2021 Sep 28;9(9):CD007662. doi: 10.1002/14651858.CD007662.pub3.
Results Reference
derived
PubMed Identifier
26139231
Citation
Schumer MC, Panza KE, Mulqueen JM, Jakubovski E, Bloch MH. LONG-TERM OUTCOME IN PEDIATRIC TRICHOTILLOMANIA. Depress Anxiety. 2015 Oct;32(10):737-43. doi: 10.1002/da.22390. Epub 2015 Jul 2.
Results Reference
derived
PubMed Identifier
23452681
Citation
Panza KE, Pittenger C, Bloch MH. Age and gender correlates of pulling in pediatric trichotillomania. J Am Acad Child Adolesc Psychiatry. 2013 Mar;52(3):241-9. doi: 10.1016/j.jaac.2012.12.019.
Results Reference
derived
PubMed Identifier
23452680
Citation
Bloch MH, Panza KE, Grant JE, Pittenger C, Leckman JF. N-Acetylcysteine in the treatment of pediatric trichotillomania: a randomized, double-blind, placebo-controlled add-on trial. J Am Acad Child Adolesc Psychiatry. 2013 Mar;52(3):231-40. doi: 10.1016/j.jaac.2012.12.020.
Results Reference
derived

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N-Acetylcysteine for Pediatric Trichotillomania

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