N-Acetylcysteine for Pediatric Trichotillomania

Trichotillomania Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00993265
• Other study ID #: 0906005337
• Secondary ID: NACPEDTTM
• Status: Completed
• Phase: Phase 2
• First received: October 9, 2009
• Last updated: June 26, 2014
• Start date: October 2009
• Est. completion date: March 2014

Study information

• Verified date: June 2014
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: March 2014
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 17 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hair Pulling
• Trichotillomania

Intervention

Drug:
• N-Acetylcysteine
2400 mg by mouth PO (1200 mg AM, 1200 mg PM), 12 weeks
• Placebo
placebo, 2 capsules by mouth in AM, 2 capsules by mouth PM, 12 weeks

Locations

Country	Name	City	State
United States	Yale Child Study Center	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	Trichotillomania Learning Center

Country where clinical trial is conducted

United States, 

References & Publications (2)

Bloch MH. Trichotillomania across the life span. J Am Acad Child Adolesc Psychiatry. 2009 Sep;48(9):879-83. doi: 10.1097/CHI.0b013e3181ae09f3. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No