NCT00993265

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2009

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

October 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 12, 2009

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
5 months until next milestone

Results Posted

Study results publicly available

July 25, 2014

Completed
Last Updated

July 25, 2014

Status Verified

June 1, 2014

Enrollment Period

2.5 years

First QC Date

October 9, 2009

Results QC Date

March 7, 2014

Last Update Submit

June 26, 2014

Conditions

TrichotillomaniaHair Pulling

Keywords

TrichotillomaniaHair pullingglutamateN-AcetylcysteineChildren

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Trichotillomania Scale for Children - Child Version

    Week 12

  • Multidimensional Anxiety Scale for Children (MASC)

    Week 12

  • Children's Depression Inventory

    Week 12

  • Trichotillomania Scale for Children - Parent Version

    Week 12

  • The Milwaukee Inventory for Styles of Trichotillomania-Child Version

    Week 12

  • +1 more secondary outcomes

Study Arms (2)

N-acetylcysteine (NAC)

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

N-AcetylcysteineDRUG

2400 mg by mouth PO (1200 mg AM, 1200 mg PM), 12 weeks

N-acetylcysteine (NAC)
PlaceboDRUG

placebo, 2 capsules by mouth in AM, 2 capsules by mouth PM, 12 weeks

Placebo

Eligibility Criteria

Age8 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 8-17 years.
  • Primary DSM-IV diagnosis of trichotillomania or chronic hair pulling.
  • Duration of trichotillomania greater than 6 months.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale Child Study Center

New Haven, Connecticut, 06520, United States

Location

Related Publications (6)

  • 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.

    PMID: 19692854BACKGROUND

  • 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.

    PMID: 19581567BACKGROUND

  • 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.

    PMID: 34582562DERIVED

  • 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.

    PMID: 26139231DERIVED

  • 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.

    PMID: 23452681DERIVED

  • 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.

    PMID: 23452680DERIVED

MeSH Terms

Conditions

Trichotillomania

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Obsessive-Compulsive DisorderAnxiety DisordersMental DisordersDisruptive, Impulse Control, and Conduct Disorders

Intervention Hierarchy (Ancestors)

CysteineAmino Acids, SulfurSulfur CompoundsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
Dr. Michael Bloch, MD, MS
Organization
Yale University, Child Study Center
michael.bloch@yale.edu
203-737-4809

Study Officials

  • Michael H. Bloch, M.D., M.S.

    Yale University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2009

First Posted

October 12, 2009

Study Start

October 1, 2009

Primary Completion

April 1, 2012

Study Completion

March 1, 2014

Last Updated

July 25, 2014

Results First Posted

July 25, 2014

Record last verified: 2014-06

Locations

US(1)