Hair Pulling, Trichotillomania
Conditions
Keywords
Trichotillomania, Hair pulling, glutamate, N-Acetylcysteine, Children
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.
Interventions
DRUGN-Acetylcysteine
2400 mg by mouth PO (1200 mg AM, 1200 mg PM), 12 weeks
DRUGPlacebo
placebo, 2 capsules by mouth in AM, 2 capsules by mouth PM, 12 weeks
Sponsors
Trichotillomania Learning Center
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
8 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Massachusetts General Hospital Hair Pulling Scale (MGH-HPS) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Multidimensional Anxiety Scale for Children (MASC) | Week 12 | 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. |
| Children's Depression Inventory | 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. |
| Trichotillomania Scale for Children - Child Version | Week 12 | 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. |
| The Milwaukee Inventory for Styles of Trichotillomania-Child Version | Week 12 | 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. |
| National Institute of Mental Health -Trichotillomania Severity Scale (NIMH-TSS) | Week 12 | 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. |
| Trichotillomania Scale for Children - Parent Version | Week 12 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 20 |
| 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 | 19 |
| Total | 39 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Changed dose of concomitant drug | 2 | 0 |
| Overall Study | Non-compliant with study medication | 1 | 0 |
Baseline characteristics
| Characteristic | Placebo | N-acetylcysteine (NAC) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 19 Participants | 20 Participants | 39 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 13.1 years STANDARD_DEVIATION 3.1 | 14 years STANDARD_DEVIATION 2.4 | 13.5 years STANDARD_DEVIATION 2.8 |
| Massachusetts General Hospital - Hairpulling Scale (MGH-HPS) | 16.6 units on a scale STANDARD_DEVIATION 4.8 | 13.2 units on a scale STANDARD_DEVIATION 5.3 | 14.9 units on a scale STANDARD_DEVIATION 5.3 |
| Multidimensional Anxiety Scale for Children (MASC) | 52.9 units on a scale STANDARD_DEVIATION 18.6 | 48.7 units on a scale STANDARD_DEVIATION 19 | 50.8 units on a scale STANDARD_DEVIATION 19 |
| Region of Enrollment United States | 19 participants | 20 participants | 39 participants |
| Sex: Female, Male Female | 17 Participants | 17 Participants | 34 Participants |
| Sex: Female, Male Male | 2 Participants | 3 Participants | 5 Participants |
| The Children's Depression Inventory (CDI) | 10.8 units on a scale STANDARD_DEVIATION 8.5 | 12.4 units on a scale STANDARD_DEVIATION 6.8 | 11.6 units on a scale STANDARD_DEVIATION 8.5 |
| The Milwaukee Inventory for Styles of Trichotillomania (MIST) - Child Version Baseline MIST-C Automatic Pulling Subscale | 16.26 units on a scale STANDARD_DEVIATION 9.8 | 12.10 units on a scale STANDARD_DEVIATION 9.3 | 14.18 units on a scale STANDARD_DEVIATION 9.8 |
| The Milwaukee Inventory for Styles of Trichotillomania (MIST) - Child Version Baseline MIST-C Focused Pulling Subscale | 90.8 units on a scale STANDARD_DEVIATION 30.5 | 94 units on a scale STANDARD_DEVIATION 35.2 | 92.4 units on a scale STANDARD_DEVIATION 35.2 |
| The Trichotillomania Scale for Children (TSC)-Child Report | 2.52 units on a scale STANDARD_DEVIATION 0.85 | 2.35 units on a scale STANDARD_DEVIATION 0.74 | 2.44 units on a scale STANDARD_DEVIATION 0.85 |
| The Trichotillomania Scale for Children (TSC)-Parent Report | 2.32 units on a scale STANDARD_DEVIATION 0.71 | 2.20 units on a scale STANDARD_DEVIATION 0.71 | 2.26 units on a scale STANDARD_DEVIATION 0.71 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 6 / 20 | 12 / 19 |
| serious Total, serious adverse events | 0 / 20 | 0 / 19 |
Outcome results
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.
Time frame: Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| N-acetylcysteine (NAC) | Massachusetts General Hospital Hair Pulling Scale (MGH-HPS) | 10.70 units on a scale | Standard Error 1.49 |
| Placebo | Massachusetts General Hospital Hair Pulling Scale (MGH-HPS) | 13.53 units on a scale | Standard Error 1.47 |
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.
Time frame: Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| N-acetylcysteine (NAC) | Children's Depression Inventory | 10.9 units on a scale | Standard Error 1.9 |
| Placebo | Children's Depression Inventory | 7.8 units on a scale | Standard Error 1.9 |
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.
Time frame: Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| N-acetylcysteine (NAC) | Multidimensional Anxiety Scale for Children (MASC) | 48.4 units on a scale | Standard Error 4.3 |
| Placebo | Multidimensional Anxiety Scale for Children (MASC) | 49.8 units on a scale | Standard Error 4.3 |
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.
Time frame: Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| N-acetylcysteine (NAC) | National Institute of Mental Health -Trichotillomania Severity Scale (NIMH-TSS) | 9.56 units on a scale | Standard Error 0.71 |
| Placebo | National Institute of Mental Health -Trichotillomania Severity Scale (NIMH-TSS) | 10.89 units on a scale | Standard Error 1.24 |
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.
Time frame: Week 12
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| N-acetylcysteine (NAC) | The Milwaukee Inventory for Styles of Trichotillomania-Child Version | Week 12 MIST-C Automatic Subscale | 13.24 units on a scale | Standard Error 1.98 |
| N-acetylcysteine (NAC) | The Milwaukee Inventory for Styles of Trichotillomania-Child Version | Week 12 MIST-C Focused Subscale | 90.8 units on a scale | Standard Error 8.1 |
| Placebo | The Milwaukee Inventory for Styles of Trichotillomania-Child Version | Week 12 MIST-C Automatic Subscale | 13.16 units on a scale | Standard Error 1.96 |
| Placebo | The Milwaukee Inventory for Styles of Trichotillomania-Child Version | Week 12 MIST-C Focused Subscale | 79.6 units on a scale | Standard Error 8.1 |
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.
Time frame: Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| N-acetylcysteine (NAC) | Trichotillomania Scale for Children - Child Version | 2.00 units on a scale | Standard Error 0.22 |
| Placebo | Trichotillomania Scale for Children - Child Version | 2.08 units on a scale | Standard Error 0.22 |
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.
Time frame: Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| N-acetylcysteine (NAC) | Trichotillomania Scale for Children - Parent Version | 1.83 units on a scale | Standard Error 0.18 |
| Placebo | Trichotillomania Scale for Children - Parent Version | 1.88 units on a scale | Standard Error 0.18 |