N-Acetylcysteine for Pediatric Trichotillomania

Study Overview
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Brief Summary
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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.

Official Title
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Double-Blind, Placebo-Controlled Trial of N-acetylcysteine for the Treatment of Pediatric Trichotillomania

Conditions
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Trichotillomania, Hair Pulling

Intervention / Treatment
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* Drug: N-Acetylcysteine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: N-acetylcysteine (NAC)<br>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<br>* 2400 mg by mouth PO (1200 mg AM, 1200 mg PM), 12 weeks<br>|
| Placebo Comparator: Placebo<br>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<br>* placebo, 2 capsules by mouth in AM, 2 capsules by mouth PM, 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Week 12 | 
| 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. | Week 12 | 
| 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. | Week 12 | 
| 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. | Week 12 | 
| 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. | Week 12 | 
| 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. | Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Trichotillomania, Hair pulling, glutamate, N-Acetylcysteine, Children