MedDataX Logo

Trial Outcomes & Findings for N-Acetyl Cysteine in Pathologic Skin Picking (NCT NCT01063348)

NCT ID: NCT01063348

Last Updated: 2023-02-23

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

66 participants

Primary outcome timeframe

Once every three weeks during the 12 week study for each subject

Results posted on

2023-02-23

Participant Flow

Participant milestones

Participant milestones
Measure
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)
Placebo
Matching placebo taken daily Placebo: Matching placebo capsules taken in same amount of pills as the active medication.
Overall Study
STARTED
35
31
Overall Study
COMPLETED
32
21
Overall Study
NOT COMPLETED
3
10

Reasons for withdrawal

Reasons for withdrawal
Measure
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)
Placebo
Matching placebo taken daily Placebo: Matching placebo capsules taken in same amount of pills as the active medication.
Overall Study
Lost to Follow-up
3
10

Baseline Characteristics

N-Acetyl Cysteine in Pathologic Skin Picking

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
N-Acetyl Cysteine
n=35 Participants
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)
Placebo
n=31 Participants
Matching placebo taken daily Placebo: Matching placebo capsules taken in same amount of pills as the active medication.
Total
n=66 Participants
Total of all reporting groups
Age, Continuous
34.9 years
STANDARD_DEVIATION 11.6 • n=5 Participants
34.7 years
STANDARD_DEVIATION 10.5 • n=7 Participants
34.8 years
STANDARD_DEVIATION 11.0 • n=5 Participants
Sex: Female, Male
Female
33 Participants
n=5 Participants
25 Participants
n=7 Participants
58 Participants
n=5 Participants
Sex: Female, Male
Male
2 Participants
n=5 Participants
6 Participants
n=7 Participants
8 Participants
n=5 Participants
Any Psychiatric Comorbidity
Yes
20 participants
n=5 Participants
14 participants
n=7 Participants
34 participants
n=5 Participants
Any Psychiatric Comorbidity
No
15 participants
n=5 Participants
17 participants
n=7 Participants
32 participants
n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
N-Acetyl Cysteine
n=32 Participants
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)
Placebo
n=21 Participants
Matching placebo taken daily Placebo: Matching placebo capsules taken in same amount of pills as the active medication.
Yale Brown Obsessive Compulsive Scale (YBOCS) Modified for PSP (NE-YBOCS)
Baseline
18.8 units on a scale
Standard Deviation 5.3
17.6 units on a scale
Standard Deviation 4.8
Yale Brown Obsessive Compulsive Scale (YBOCS) Modified for PSP (NE-YBOCS)
Week 3
16.1 units on a scale
Standard Deviation 5.9
17.3 units on a scale
Standard Deviation 5.4
Yale Brown Obsessive Compulsive Scale (YBOCS) Modified for PSP (NE-YBOCS)
Week 6
13.9 units on a scale
Standard Deviation 6.3
16.3 units on a scale
Standard Deviation 6.9
Yale Brown Obsessive Compulsive Scale (YBOCS) Modified for PSP (NE-YBOCS)
Week 9
12.4 units on a scale
Standard Deviation 5.8
15.0 units on a scale
Standard Deviation 7.4
Yale Brown Obsessive Compulsive Scale (YBOCS) Modified for PSP (NE-YBOCS)
Week 12
11.5 units on a scale
Standard Deviation 5.4
14.1 units on a scale
Standard Deviation 7.5

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
N-Acetyl Cysteine
n=32 Participants
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)
Placebo
n=21 Participants
Matching placebo taken daily Placebo: Matching placebo capsules taken in same amount of pills as the active medication.
Skin Picking Self Assessment Scale (SP-SAS)
Baseline
28.6 units on a scale
Standard Deviation 6.2
28.6 units on a scale
Standard Deviation 7.0
Skin Picking Self Assessment Scale (SP-SAS)
Week 3
24.8 units on a scale
Standard Deviation 7.2
25.5 units on a scale
Standard Deviation 6.2
Skin Picking Self Assessment Scale (SP-SAS)
Week 6
21.9 units on a scale
Standard Deviation 8.0
25.0 units on a scale
Standard Deviation 8.8
Skin Picking Self Assessment Scale (SP-SAS)
Week 9
21.5 units on a scale
Standard Deviation 10.3
24.2 units on a scale
Standard Deviation 8.5
Skin Picking Self Assessment Scale (SP-SAS)
Week 12
19.4 units on a scale
Standard Deviation 8.7
24.5 units on a scale
Standard Deviation 9.0

Adverse Events

N-Acetyl Cysteine

Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths

Placebo

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
N-Acetyl Cysteine
n=35 participants at risk
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)
Placebo
n=31 participants at risk
Matching placebo taken daily Placebo: Matching placebo capsules taken in same amount of pills as the active medication.
Gastrointestinal disorders
Nausea
14.3%
5/35
3.2%
1/31
General disorders
Dry Mouth
2.9%
1/35
0.00%
0/31
Gastrointestinal disorders
Constipation
5.7%
2/35
0.00%
0/31
General disorders
Dizziness
2.9%
1/35
0.00%
0/31

Additional Information

Dr. Jon Grant

University of Chicago

Phone: 773-834-1325

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place