N-Acetylcysteine for Pediatric Trichotillomania

This study has been completed.
Sponsor:
Collaborator:
Trichotillomania Learning Center
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT00993265
First received: October 9, 2009
Last updated: June 26, 2014
Last verified: June 2014
Results First Received: March 7, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Trichotillomania
Hair Pulling
Interventions: Drug: N-Acetylcysteine
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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


Participant Flow:   Overall Study
    N-acetylcysteine (NAC)     Placebo  
STARTED     20     19  
COMPLETED     16     19  
NOT COMPLETED     4     0  
Adverse Event                 1                 0  
Changed dose of concomitant drug                 2                 0  
Non-compliant with study medication                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
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

Total Total of all reporting groups

Baseline Measures
    N-acetylcysteine (NAC)     Placebo     Total  
Number of Participants  
[units: participants]
  20     19     39  
Age  
[units: participants]
     
<=18 years     20     19     39  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  14  ± 2.4     13.1  ± 3.1     13.5  ± 2.8  
Gender  
[units: participants]
     
Female     17     17     34  
Male     3     2     5  
Region of Enrollment  
[units: participants]
     
United States     20     19     39  
Massachusetts General Hospital - Hairpulling Scale (MGH-HPS) [1]
[units: units on a scale]
Mean ± Standard Deviation
  13.2  ± 5.3     16.6  ± 4.8     14.9  ± 5.3  
The Trichotillomania Scale for Children (TSC)-Child Report [2]
[units: units on a scale]
Mean ± Standard Deviation
  2.35  ± .74     2.52  ± .85     2.44  ± .85  
The Trichotillomania Scale for Children (TSC)-Parent Report [3]
[units: units on a scale]
Mean ± Standard Deviation
  2.20  ± 0.71     2.32  ± 0.71     2.26  ± 0.71  
The Milwaukee Inventory for Styles of Trichotillomania (MIST) - Child Version [4]
[units: 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) [5]
[units: units on a scale]
Mean ± Standard Deviation
  48.7  ± 19.0     52.9  ± 18.6     50.8  ± 19.0  
The Children's Depression Inventory (CDI) [6]
[units: units on a scale]
Mean ± Standard Deviation
  12.4  ± 6.8     10.8  ± 8.5     11.6  ± 8.5  
[1] 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.
[2] 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.
[3] 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.
[4] 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.
[5] 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.
[6] 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.



  Outcome Measures
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1.  Primary:   Massachusetts General Hospital Hair Pulling Scale (MGH-HPS)   [ Time Frame: Week 12 ]

2.  Secondary:   Trichotillomania Scale for Children - Child Version   [ Time Frame: Week 12 ]

3.  Secondary:   Multidimensional Anxiety Scale for Children (MASC)   [ Time Frame: Week 12 ]

4.  Secondary:   Children's Depression Inventory   [ Time Frame: Week 12 ]

5.  Secondary:   Trichotillomania Scale for Children - Parent Version   [ Time Frame: Week 12 ]

6.  Secondary:   The Milwaukee Inventory for Styles of Trichotillomania–Child Version   [ Time Frame: Week 12 ]

7.  Secondary:   National Institute of Mental Health –Trichotillomania Severity Scale (NIMH-TSS)   [ Time Frame: Week 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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
e-mail: michael.bloch@yale.edu


Publications:
Publications automatically indexed to this study:

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00993265     History of Changes
Other Study ID Numbers: 0906005337, NACPEDTTM
Study First Received: October 9, 2009
Results First Received: March 7, 2014
Last Updated: June 26, 2014
Health Authority: United States: Institutional Review Board