Dermatillomania, Neurotic Excoriation, Pathologic Skin Picking, Psychogenic Excoriation
Conditions
Keywords
N-Acetyl Cysteine, Picking, Impulse Control Disorder, Obsessive Compulsive Disorder
Brief summary
The goal of the proposed study is to evaluate the comparative efficacy of N-acetyl cysteine to placebo in pathologic skin picking. Thirty subjects with pathologic skin picking will receive 12 weeks of double-blind treatment with N-acetyl cysteine or matching placebo. The hypothesis to be tested is that N-acetyl cysteine will be more effective than placebo in patients with pathologic skin picking. The proposed study will provide needed data on the treatment of an often disabling disorder that currently lacks a clearly effective treatment.
Detailed description
Pathologic skin picking involves repetitive, ritualistic, or impulsive picking of otherwise normal skin leading to tissue damage, personal distress, and impaired functioning. Although skin picking has been described in the medical literature for over one-hundred years, it remains a poorly understood psychiatric issue and often goes undiagnosed and untreated. Picking behavior does not by itself suggest a psychiatric disorder. Pathology exists in the focus, duration and extent of the behavior, as well as the reasons for picking, associated emotions, and resulting problems. Patients with PSP report thoughts of picking or impulses to pick that are irresistible, intrusive and/or senseless. These thoughts, impulses, or behaviors also cause marked distress for patients and significantly interfere with other activities. Unlike normal picking behavior, the pathologic form of skin picking is recurrent and usually results in noticeable skin damage. Thirty subjects with pathologic skin picking will receive 12 weeks of double-blind treatment with N-acetyl cysteine or matching placebo. The hypothesis to be tested is that N-acetyl cysteine will be more effective than placebo in patients with pathologic skin picking. The proposed study will provide needed data on the treatment of an often disabling disorder that currently lacks a clearly effective treatment.
Interventions
DRUGN-Acetyl Cysteine
Week 0 (Visit 1) - Week 3 (V2): 1200mg/day (600mg po qam and 600mg po qpm) Week 3 (V2) - Week 6 (V3): 2400mg/day (1200mg po qam and 1200mg po qpm) Week 6 (V4) - Week 12 (V5): 3000mg/day (1200mg po qam and 1800mg po qpm)
DRUGPlacebo
Matching placebo capsules taken in same amount of pills as the active medication.
Sponsors
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
1. Men and women age 18-65; 2. Current diagnosis of pathologic skin picking as determined by criteria proposed by Arnold et al. (2001) for at least 6 months duration
Exclusion criteria
1. Unstable medical illness or clinically significant abnormalities on prestudy laboratory tests or physical examination; 2. History of seizures; 3. Myocardial infarction within 6 months; 4. Current pregnancy or lactation, or inadequate contraception in women of childbearing potential; 5. Need for medication other than NAC with possible psychotropic effects or unfavorable interactions with NAC; 6. Clinically significant suicidality (score or 3 or 4 on item 3 of the Hamilton Depression Rating Scale); 7. Lifetime history of DSM-IV bipolar disorder type I, dementia, or schizophrenia or any other DSM-IV psychotic disorder; 8. Current or recent (past 3 months) DSM-IV substance abuse or dependence; 9. Illegal substance use within 2 weeks of study initiation; 10. Initiation of pharmacotherapy, psychotherapy, or behavior therapy from a mental health professional within 3 months prior to study baseline for the treatment of pathologic skin picking; 11. Previous treatment with N-acetyl cysteine; 12. Treatment with investigational medication or depot neuroleptics within 3 months, with fluoxetine within 6 weeks, or with other psychotropics within 2 weeks prior to study baseline; 13. Asthma (given possible worsening of asthma due to NAC)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Yale Brown Obsessive Compulsive Scale (YBOCS) Modified for PSP (NE-YBOCS) | Once every three weeks during the 12 week study for each subject | The entire study for an individual subject will last 12 weeks. Every 3 weeks the subject will take the YBOCS for the duration of the 12 weeks. At each of these visits the outcome will be assessed. The minimum score is 0 and the maximum score is 40, with a higher score being more severe skin picking. There are two sub-scales: one for urges (ranges from 0 to 20) and one for behaviors (ranges from 0 to 20). The total of the scores of each of the sub-scales is the total YBOCS score. That is what will be reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Skin Picking Self Assessment Scale (SP-SAS) | Once every three weeks for the duration of the 12 week study for each subject | The entire study for an individual subject will last 12 weeks. Every 3 weeks the subject will take the YBOCS for the duration of the 12 weeks. At each of these visits the outcome will be assessed. The minimum score is 0 and the maximum score is 48 with higher scores meaning more severe skin picking. The total of all of the questions equals the total reported SP-SAS score. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| N-Acetyl Cysteine N-Acetyl Cysteine - 600mg tablets by mouth (dosing 1200mg - 3000mg qd)
N-Acetyl Cysteine: Week 0 (Visit 1) - Week 3 (V2): 1200mg/day (600mg po qam and 600mg po qpm) Week 3 (V2) - Week 6 (V3): 2400mg/day (1200mg po qam and 1200mg po qpm) Week 6 (V4) - Week 12 (V5): 3000mg/day (1200mg po qam and 1800mg po qpm) | 35 |
| Placebo Matching placebo taken daily
Placebo: Matching placebo capsules taken in same amount of pills as the active medication. | 31 |
| Total | 66 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 10 |
Baseline characteristics
| Characteristic | N-Acetyl Cysteine | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 34.9 years STANDARD_DEVIATION 11.6 | 34.7 years STANDARD_DEVIATION 10.5 | 34.8 years STANDARD_DEVIATION 11 |
| Any Psychiatric Comorbidity No | 15 participants | 17 participants | 32 participants |
| Any Psychiatric Comorbidity Yes | 20 participants | 14 participants | 34 participants |
| Sex: Female, Male Female | 33 Participants | 25 Participants | 58 Participants |
| Sex: Female, Male Male | 2 Participants | 6 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 9 / 35 | 1 / 31 |
| serious Total, serious adverse events | 0 / 35 | 0 / 31 |
Outcome results
Primary
Yale Brown Obsessive Compulsive Scale (YBOCS) Modified for PSP (NE-YBOCS)
The entire study for an individual subject will last 12 weeks. Every 3 weeks the subject will take the YBOCS for the duration of the 12 weeks. At each of these visits the outcome will be assessed. The minimum score is 0 and the maximum score is 40, with a higher score being more severe skin picking. There are two sub-scales: one for urges (ranges from 0 to 20) and one for behaviors (ranges from 0 to 20). The total of the scores of each of the sub-scales is the total YBOCS score. That is what will be reported.
Time frame: Once every three weeks during the 12 week study for each subject
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| N-Acetyl Cysteine | Yale Brown Obsessive Compulsive Scale (YBOCS) Modified for PSP (NE-YBOCS) | Week 3 | 16.1 units on a scale | Standard Deviation 5.9 |
| N-Acetyl Cysteine | Yale Brown Obsessive Compulsive Scale (YBOCS) Modified for PSP (NE-YBOCS) | Week 9 | 12.4 units on a scale | Standard Deviation 5.8 |
| N-Acetyl Cysteine | Yale Brown Obsessive Compulsive Scale (YBOCS) Modified for PSP (NE-YBOCS) | Week 6 | 13.9 units on a scale | Standard Deviation 6.3 |
| N-Acetyl Cysteine | Yale Brown Obsessive Compulsive Scale (YBOCS) Modified for PSP (NE-YBOCS) | Week 12 | 11.5 units on a scale | Standard Deviation 5.4 |
| N-Acetyl Cysteine | Yale Brown Obsessive Compulsive Scale (YBOCS) Modified for PSP (NE-YBOCS) | Baseline | 18.8 units on a scale | Standard Deviation 5.3 |
| Placebo | Yale Brown Obsessive Compulsive Scale (YBOCS) Modified for PSP (NE-YBOCS) | Week 12 | 14.1 units on a scale | Standard Deviation 7.5 |
| Placebo | Yale Brown Obsessive Compulsive Scale (YBOCS) Modified for PSP (NE-YBOCS) | Baseline | 17.6 units on a scale | Standard Deviation 4.8 |
| Placebo | Yale Brown Obsessive Compulsive Scale (YBOCS) Modified for PSP (NE-YBOCS) | Week 3 | 17.3 units on a scale | Standard Deviation 5.4 |
| Placebo | Yale Brown Obsessive Compulsive Scale (YBOCS) Modified for PSP (NE-YBOCS) | Week 6 | 16.3 units on a scale | Standard Deviation 6.9 |
| Placebo | Yale Brown Obsessive Compulsive Scale (YBOCS) Modified for PSP (NE-YBOCS) | Week 9 | 15.0 units on a scale | Standard Deviation 7.4 |
Secondary
Skin Picking Self Assessment Scale (SP-SAS)
The entire study for an individual subject will last 12 weeks. Every 3 weeks the subject will take the YBOCS for the duration of the 12 weeks. At each of these visits the outcome will be assessed. The minimum score is 0 and the maximum score is 48 with higher scores meaning more severe skin picking. The total of all of the questions equals the total reported SP-SAS score.
Time frame: Once every three weeks for the duration of the 12 week study for each subject
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| N-Acetyl Cysteine | Skin Picking Self Assessment Scale (SP-SAS) | Week 3 | 24.8 units on a scale | Standard Deviation 7.2 |
| N-Acetyl Cysteine | Skin Picking Self Assessment Scale (SP-SAS) | Week 9 | 21.5 units on a scale | Standard Deviation 10.3 |
| N-Acetyl Cysteine | Skin Picking Self Assessment Scale (SP-SAS) | Week 6 | 21.9 units on a scale | Standard Deviation 8 |
| N-Acetyl Cysteine | Skin Picking Self Assessment Scale (SP-SAS) | Week 12 | 19.4 units on a scale | Standard Deviation 8.7 |
| N-Acetyl Cysteine | Skin Picking Self Assessment Scale (SP-SAS) | Baseline | 28.6 units on a scale | Standard Deviation 6.2 |
| Placebo | Skin Picking Self Assessment Scale (SP-SAS) | Week 12 | 24.5 units on a scale | Standard Deviation 9 |
| Placebo | Skin Picking Self Assessment Scale (SP-SAS) | Baseline | 28.6 units on a scale | Standard Deviation 7 |
| Placebo | Skin Picking Self Assessment Scale (SP-SAS) | Week 3 | 25.5 units on a scale | Standard Deviation 6.2 |
| Placebo | Skin Picking Self Assessment Scale (SP-SAS) | Week 6 | 25.0 units on a scale | Standard Deviation 8.8 |
| Placebo | Skin Picking Self Assessment Scale (SP-SAS) | Week 9 | 24.2 units on a scale | Standard Deviation 8.5 |