N-Acetyl Cysteine in Pathologic Skin Picking
Pathologic Skin Picking
Drug: N-Acetyl Cysteine
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Double-Blind, Placebo-Controlled Study of N-Acetyl Cysteine in Pathologic Skin Picking|
- Yale Brown Obsessive Compulsive Scale (YBOCS) modified for PSP (NE-YBOCS) [ Time Frame: Once every three weeks during the 12 week study for each subject ] [ Designated as safety issue: No ]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.
- Skin Picking Self Assessment Scale (SP-SAS) [ Time Frame: Once every three weeks for the duration of the 12 week study for each subject ] [ Designated as safety issue: No ]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.
|Study Start Date:||September 2012|
|Study Completion Date:||July 2015|
|Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
Active Comparator: N-Acetyl Cysteine
N-Acetyl Cysteine - 600mg tablets by mouth (dosing 1200mg - 3000mg qd)
Drug: 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)
Other Name: NAC
Placebo Comparator: Placebo
Matching placebo taken daily
Matching placebo capsules taken in same amount of pills as the active medication.
Other Name: Sugar pill
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01063348
|United States, Illinois|
|University of Chicago|
|Chicago, Illinois, United States, 60637|
|Principal Investigator:||Jon E Grant, MD, JD, MPH||University of Chicago|