Trial Outcomes & Findings for N-Acetyl Cysteine in Trichotillomania (NCT NCT00354770)

Last Updated: 2023-02-23

Results Overview

There is no minimum or maximum score to quantify 'good' or 'poor' improvement based on this scale. The total score can range from 0-28 with zero being no problems to 28 being the most severe score one can receive.A total of 6 assessments were made, however only the final score (the score at the final visit after 12 weeks) was reported here to show the final outcome measure that was used in the final report of possible improvement and what was reported for final publication of data.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

50 participants

Primary outcome timeframe

Baseline and final visit after 12 weeks

Results posted on

2023-02-23

Participant Flow

Participant milestones

Participant milestones
Measure	N-Acetyl Cysteine N-Acetyl Cysteine (NAC) - 1200mg-2400mg by mouth per day	Placebo Placebo pills
Overall Study STARTED	25	25
Overall Study COMPLETED	22	22
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

N-Acetyl Cysteine in Trichotillomania

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	N-Acetyl Cysteine n=25 Participants N-Acetyl Cysteine (NAC) - 1200mg-2400mg by mouth per day	Placebo n=25 Participants Placebo pills	Total n=50 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=99 Participants	25 Participants n=107 Participants	50 Participants n=206 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Continuous	35.8 years STANDARD_DEVIATION 13.6 • n=99 Participants	32.7 years STANDARD_DEVIATION 10.5 • n=107 Participants	34.5 years STANDARD_DEVIATION 11.5 • n=206 Participants
Sex: Female, Male Female	24 Participants n=99 Participants	21 Participants n=107 Participants	45 Participants n=206 Participants
Sex: Female, Male Male	1 Participants n=99 Participants	4 Participants n=107 Participants	5 Participants n=206 Participants
Region of Enrollment United States	25 participants n=99 Participants	25 participants n=107 Participants	50 participants n=206 Participants

PRIMARY outcome

Timeframe: Baseline and final visit after 12 weeks

Outcome measures

Outcome measures
Measure	N-Acetyl Cysteine n=25 Participants N-Acetyl Cysteine (NAC) - 1200mg-2400mg by mouth per day	Placebo n=25 Participants Placebo pills
Massachusetts General Hospital Hairpulling Scale MGH-HPS Baseline	17.6 units on a scale Standard Deviation 4.64	16.7 units on a scale Standard Deviation 5.28
Massachusetts General Hospital Hairpulling Scale MGH-HPS Final Visit After 12 Weeks	10.4 units on a scale Standard Deviation 5.55	16.0 units on a scale Standard Deviation 4.90

Adverse Events

N-Acetyl Cysteine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	N-Acetyl Cysteine n=25 participants at risk N-Acetyl Cysteine (NAC) - 1200mg-2400mg by mouth per day	Placebo n=25 participants at risk Placebo pills
Gastrointestinal disorders Diarrhea	0.00% 0/25	8.0% 2/25 • Number of events 2
Gastrointestinal disorders Nausea	0.00% 0/25	4.0% 1/25 • Number of events 1

Additional Information

Jon E. Grant

University of Chicago

Phone: 773-834-1325

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place