Trial Outcomes & Findings for Signatures of N-Ac for Non-Suicidal Self-Injury in Adolescents (NCT NCT04005053)
NCT ID: NCT04005053
Last Updated: 2023-08-15
Results Overview
increase in glutathione (GSH) concentrations in the anterior cingulate cortex (ACC) as measured by magnetic resonance spectroscopy (MRS)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
44 participants
Primary outcome timeframe
28 days
Results posted on
2023-08-15
Participant Flow
Participant milestones
| Measure |
Low-Dose NAC
3600 NAC mg/day
N-acetyl cysteine: 3600 or 5400 mg/day N-acetyl cysteine
|
High-Dose NAC
5400 NAC mg/day
N-acetyl cysteine: 3600 or 5400 mg/day N-acetyl cysteine
|
Placebo
Placebo
Placebo oral tablet: Placebo
|
|---|---|---|---|
|
Overall Study
STARTED
|
16
|
13
|
15
|
|
Overall Study
COMPLETED
|
14
|
11
|
14
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Signatures of N-Ac for Non-Suicidal Self-Injury in Adolescents
Baseline characteristics by cohort
| Measure |
Low-Dose NAC
n=14 Participants
3600 NAC mg/day
N-acetyl cysteine: 3600 or 5400 mg/day N-acetyl cysteine
|
High-Dose NAC
n=11 Participants
5400 NAC mg/day
N-acetyl cysteine: 3600 or 5400 mg/day N-acetyl cysteine
|
Placebo
n=14 Participants
Placebo
Placebo oral tablet: Placebo
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
21 years
STANDARD_DEVIATION 2 • n=93 Participants
|
21 years
STANDARD_DEVIATION 2 • n=4 Participants
|
21 years
STANDARD_DEVIATION 2 • n=27 Participants
|
21 years
STANDARD_DEVIATION 2 • n=483 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
39 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
30 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: 28 daysincrease in glutathione (GSH) concentrations in the anterior cingulate cortex (ACC) as measured by magnetic resonance spectroscopy (MRS)
Outcome measures
| Measure |
Placebo
n=14 Participants
Placebo
Placebo oral tablet: Placebo
|
Low-Dose NAC
n=14 Participants
3600 NAC mg/day
N-acetyl cysteine: 3600 or 5400 mg/day N-acetyl cysteine
|
High-Dose NAC
n=11 Participants
5400 NAC mg/day
N-acetyl cysteine: 3600 or 5400 mg/day N-acetyl cysteine
|
|---|---|---|---|
|
Percent Increase in Glutathione (GSH) Concentrations in the ACC
|
2 Percent change
Standard Deviation 15
|
5 Percent change
Standard Deviation 12
|
0 Percent change
Standard Deviation 10
|
SECONDARY outcome
Timeframe: 28 daysPercent increase in reduced-to-oxidized ratio of glutathione (GSH) in the blood compared to baseline
Outcome measures
| Measure |
Placebo
n=14 Participants
Placebo
Placebo oral tablet: Placebo
|
Low-Dose NAC
n=14 Participants
3600 NAC mg/day
N-acetyl cysteine: 3600 or 5400 mg/day N-acetyl cysteine
|
High-Dose NAC
n=11 Participants
5400 NAC mg/day
N-acetyl cysteine: 3600 or 5400 mg/day N-acetyl cysteine
|
|---|---|---|---|
|
Change in GSH Reduced-to-oxidized Ratio
|
-5 percent change
Standard Deviation 26
|
14 percent change
Standard Deviation 15
|
28 percent change
Standard Deviation 51
|
SECONDARY outcome
Timeframe: 28 daysPercent decrease in the concentrations of glutamate (GLU) in the anterior cingulate cortex (ACC) measured by MRS
Outcome measures
| Measure |
Placebo
n=14 Participants
Placebo
Placebo oral tablet: Placebo
|
Low-Dose NAC
n=14 Participants
3600 NAC mg/day
N-acetyl cysteine: 3600 or 5400 mg/day N-acetyl cysteine
|
High-Dose NAC
n=11 Participants
5400 NAC mg/day
N-acetyl cysteine: 3600 or 5400 mg/day N-acetyl cysteine
|
|---|---|---|---|
|
Change in Glutamate Concentrations
|
-0.8 percent change
Standard Deviation 4.6
|
-0.9 percent change
Standard Deviation 2.6
|
-1.2 percent change
Standard Deviation 4.2
|
Adverse Events
Low-Dose NAC
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
High-Dose NAC
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Low-Dose NAC
n=14 participants at risk
3600 NAC mg/day
N-acetyl cysteine: 3600 or 5400 mg/day N-acetyl cysteine
|
High-Dose NAC
n=11 participants at risk
5400 NAC mg/day
N-acetyl cysteine: 3600 or 5400 mg/day N-acetyl cysteine
|
Placebo
n=14 participants at risk
Placebo
Placebo oral tablet: Placebo
|
|---|---|---|---|
|
Psychiatric disorders
Hospitalization due to suicidality
|
0.00%
0/14 • recorded by study staff throughout the study occurring any time after informed consent is obtained for 8 weeks.
|
0.00%
0/11 • recorded by study staff throughout the study occurring any time after informed consent is obtained for 8 weeks.
|
7.1%
1/14 • Number of events 1 • recorded by study staff throughout the study occurring any time after informed consent is obtained for 8 weeks.
|
Other adverse events
| Measure |
Low-Dose NAC
n=14 participants at risk
3600 NAC mg/day
N-acetyl cysteine: 3600 or 5400 mg/day N-acetyl cysteine
|
High-Dose NAC
n=11 participants at risk
5400 NAC mg/day
N-acetyl cysteine: 3600 or 5400 mg/day N-acetyl cysteine
|
Placebo
n=14 participants at risk
Placebo
Placebo oral tablet: Placebo
|
|---|---|---|---|
|
Psychiatric disorders
Psychiatric
|
35.7%
5/14 • Number of events 7 • recorded by study staff throughout the study occurring any time after informed consent is obtained for 8 weeks.
|
36.4%
4/11 • Number of events 5 • recorded by study staff throughout the study occurring any time after informed consent is obtained for 8 weeks.
|
35.7%
5/14 • Number of events 8 • recorded by study staff throughout the study occurring any time after informed consent is obtained for 8 weeks.
|
|
Gastrointestinal disorders
Gastrointestinal
|
35.7%
5/14 • Number of events 5 • recorded by study staff throughout the study occurring any time after informed consent is obtained for 8 weeks.
|
45.5%
5/11 • Number of events 6 • recorded by study staff throughout the study occurring any time after informed consent is obtained for 8 weeks.
|
21.4%
3/14 • Number of events 4 • recorded by study staff throughout the study occurring any time after informed consent is obtained for 8 weeks.
|
|
Cardiac disorders
Cardiovascular
|
0.00%
0/14 • recorded by study staff throughout the study occurring any time after informed consent is obtained for 8 weeks.
|
0.00%
0/11 • recorded by study staff throughout the study occurring any time after informed consent is obtained for 8 weeks.
|
7.1%
1/14 • Number of events 2 • recorded by study staff throughout the study occurring any time after informed consent is obtained for 8 weeks.
|
|
Nervous system disorders
Nervous system
|
0.00%
0/14 • recorded by study staff throughout the study occurring any time after informed consent is obtained for 8 weeks.
|
0.00%
0/11 • recorded by study staff throughout the study occurring any time after informed consent is obtained for 8 weeks.
|
35.7%
5/14 • Number of events 5 • recorded by study staff throughout the study occurring any time after informed consent is obtained for 8 weeks.
|
|
Skin and subcutaneous tissue disorders
skin
|
0.00%
0/14 • recorded by study staff throughout the study occurring any time after informed consent is obtained for 8 weeks.
|
0.00%
0/11 • recorded by study staff throughout the study occurring any time after informed consent is obtained for 8 weeks.
|
14.3%
2/14 • Number of events 3 • recorded by study staff throughout the study occurring any time after informed consent is obtained for 8 weeks.
|
|
Ear and labyrinth disorders
ENT
|
0.00%
0/14 • recorded by study staff throughout the study occurring any time after informed consent is obtained for 8 weeks.
|
0.00%
0/11 • recorded by study staff throughout the study occurring any time after informed consent is obtained for 8 weeks.
|
14.3%
2/14 • Number of events 3 • recorded by study staff throughout the study occurring any time after informed consent is obtained for 8 weeks.
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal
|
0.00%
0/14 • recorded by study staff throughout the study occurring any time after informed consent is obtained for 8 weeks.
|
0.00%
0/11 • recorded by study staff throughout the study occurring any time after informed consent is obtained for 8 weeks.
|
7.1%
1/14 • Number of events 1 • recorded by study staff throughout the study occurring any time after informed consent is obtained for 8 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place