TrichotillomaniaPhase 2NCT00993265
N-Acetylcysteine for Pediatric Trichotillomania
A Phase 2 study testing N-Acetylcysteine in people with Trichotillomania and Hair Pulling, run by Yale University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Trichotillomania, Hair Pulling
- What is being tested?
- N-Acetylcysteine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Mar 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 8-17 years.
- Primary DSM-IV diagnosis of trichotillomania or chronic hair pulling.
- Duration of trichotillomania greater than 6 months.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale Child Study Center
New Haven, Connecticut, 06520
About this study
Official title: Double-Blind, Placebo-Controlled Trial of N-acetylcysteine for the Treatment of Pediatric Trichotillomania
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.
- Conditions
- Trichotillomania, Hair Pulling
- Being tested
- N-Acetylcysteine, Placebo
- Keywords
- Trichotillomania, Hair pulling, glutamate, N-Acetylcysteine, Children
- Medical subject headings
- Trichotillomania
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-AcetylcysteineDrug
2400 mg by mouth PO (1200 mg AM, 1200 mg PM), 12 weeks
PlaceboDrug
placebo, 2 capsules by mouth in AM, 2 capsules by mouth PM, 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 12
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionApr 2012
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for TrichotillomaniaStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Trichotillomania Learning Center
- Responsible party
- Sponsor
- Investigators
- Michael H. Bloch, M.D., M.S., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00993265
- Sponsor's protocol ID
- 0906005337
- Other IDs
- NACPEDTTM
- Status last verified
- Jun 2014
- First submitted
- 9 Oct 2009
- Last updated
- 25 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 19692854Grant 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.
PubMed 19581567Hoffman 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.
PubMed 34582562Schumer 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.
PubMed 26139231Panza 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.
PubMed 23452681Bloch 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.
PubMed 23452680
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind, Placebo-Controlled Trial of N-acetylcysteine for the Treatment of Pediatric Trichotillomania
- ClinicalTrials.gov ID
- NCT00993265
- Acronym / sponsor ID
- 0906005337
- Conditions
- Trichotillomania, Hair Pulling
- Keywords
- Trichotillomania, Hair pulling, glutamate, N-Acetylcysteine, Children
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Trichotillomania Learning Center
- Study start
- Oct 2009
- Primary completion
- Apr 2012 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 12 Oct 2009 (estimated)
- Results
- Posted 25 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| N-acetylcysteine (NAC) | Experimental | Drug: N-AcetylcysteinePatients 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. |
| Placebo | Placebo comparator | Drug: PlaceboPatients 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. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged 8-17 years.
- Primary DSM-IV diagnosis of trichotillomania or chronic hair pulling.
- Duration of trichotillomania greater than 6 months.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N-Acetylcysteine2400 mg by mouth PO (1200 mg AM, 1200 mg PM), 12 weeks | Drug | N-acetylcysteine (NAC) |
| Placeboplacebo, 2 capsules by mouth in AM, 2 capsules by mouth PM, 12 weeks | Drug | Placebo |
Primary outcome
Massachusetts General Hospital Hair Pulling Scale (MGH-HPS)
Time frame: Week 12
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.
6 secondary outcomes
Trichotillomania Scale for Children - Child Version
Time frame: Week 12
Multidimensional Anxiety Scale for Children (MASC)
Time frame: Week 12
Children's Depression Inventory
Time frame: Week 12
Trichotillomania Scale for Children - Parent Version
Time frame: Week 12
The Milwaukee Inventory for Styles of Trichotillomania-Child Version
Time frame: Week 12
National Institute of Mental Health -Trichotillomania Severity Scale (NIMH-TSS)
Time frame: Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19692854Bloch 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.
- Background: PubMed 19581567Grant 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.
- Derived from this study: PubMed 34582562Hoffman 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.
- Derived from this study: PubMed 26139231Schumer 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.
- Derived from this study: PubMed 23452681Panza 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.
- Derived from this study: PubMed 23452680Bloch 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael H. Bloch, M.D., M.S. principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing N-Acetylcysteine in people with Trichotillomania and Hair Pulling, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Massachusetts General Hospital Hair Pulling Scale (MGH-HPS) (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00993265, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2014.