Trial Outcomes & Findings for Evaluating the Hypothesized Mechanism of Action of N-acetylcysteine for Bipolar Disorder (NCT NCT05340504)
NCT ID: NCT05340504
Last Updated: 2024-06-26
Results Overview
Brain GSH levels, balanced with water and CSF-corrected, in dorsal anterior cingulate measured via Proton Magnetic Resonance Spectroscopy
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
Day 14 of each experimental condition
Results posted on
2024-06-26
Participant Flow
Participant milestones
| Measure |
Group A: N-Acetylcysteine, Washout, Then Placebo Oral Capsule
Two, 2-week conditions.
Week 1 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), maximum dose of NAC (i.e., 3g/day NAC) (Days 1-14), MRI (Day 14) and medication washout (Day 15-28).
N-Acetylcysteine: 14 day trial of 3g NAC.
Week 2 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), maximum dose of matched Placebo Oral Capsule (Days 1-14), and MRI (Day 14).
Placebo Oral Capsule: 14 day trial of matched placebo.
|
Group B: Placebo Oral Capsule, Washout, Then N-Acetylcysteine
Two, 2-week conditions.
Week 1 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), maximum dose of matched Placebo Oral Capsule (Days 1-14), MRI (Day 14) and medication washout (Day 15-28).
Placebo Oral Capsule: 14 day trial of matched placebo.
Week 2 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), maximum dose of NAC (i.e., 3g/day NAC) (Days 1-14), and MRI (Day 14).
N-Acetylcysteine: 14 day trial of 3g NAC.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
|
Overall Study
COMPLETED
|
5
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Group A: N-Acetylcysteine, Washout, Then Placebo Oral Capsule
Two, 2-week conditions.
Week 1 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), maximum dose of NAC (i.e., 3g/day NAC) (Days 1-14), MRI (Day 14) and medication washout (Day 15-28).
N-Acetylcysteine: 14 day trial of 3g NAC.
Week 2 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), maximum dose of matched Placebo Oral Capsule (Days 1-14), and MRI (Day 14).
Placebo Oral Capsule: 14 day trial of matched placebo.
|
Group B: Placebo Oral Capsule, Washout, Then N-Acetylcysteine
Two, 2-week conditions.
Week 1 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), maximum dose of matched Placebo Oral Capsule (Days 1-14), MRI (Day 14) and medication washout (Day 15-28).
Placebo Oral Capsule: 14 day trial of matched placebo.
Week 2 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), maximum dose of NAC (i.e., 3g/day NAC) (Days 1-14), and MRI (Day 14).
N-Acetylcysteine: 14 day trial of 3g NAC.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Evaluating the Hypothesized Mechanism of Action of N-acetylcysteine for Bipolar Disorder
Baseline characteristics by cohort
| Measure |
Group A: N-Acetylcysteine, Washout, Then Placebo Oral Capsule
n=6 Participants
Two, 2-week conditions.
Week 1 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), maximum dose of NAC (i.e., 3g/day NAC) (Days 1-14), MRI (Day 14) and medication washout (Day 15-28).
N-Acetylcysteine: 14 day trial of 3g NAC.
Week 2 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), maximum dose of matched Placebo Oral Capsule (Days 1-14), and MRI (Day 14).
Placebo Oral Capsule: 14 day trial of matched placebo.
|
Group B: Placebo Oral Capsule, Washout, Then N-Acetylcysteine
n=6 Participants
Two, 2-week conditions.
Week 1 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), maximum dose of matched Placebo Oral Capsule (Days 1-14), MRI (Day 14) and medication washout (Day 15-28).
Placebo Oral Capsule: 14 day trial of matched placebo.
Week 2 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), maximum dose of NAC (i.e., 3g/day NAC) (Days 1-14), and MRI (Day 14).
N-Acetylcysteine: 14 day trial of 3g NAC.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Continuous
|
34.5 years
n=93 Participants
|
41.33 years
n=4 Participants
|
37.92 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=93 Participants
|
6 participants
n=4 Participants
|
12 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Day 14 of each experimental conditionPopulation: Overall number of participants analyzed includes participants who completed full study protocol (i.e. 2, 2-week medication trials and 1, 2-week washout period). Two participants have been removed from outcome measure data (1 - participant lost to follow up and did not complete placebo condition, 1 - participant's MRI data was unusable due to excessive head motion). Data from these 2 participants has been included in other portions of this study record (Adverse Events, Demographics, etc).
Brain GSH levels, balanced with water and CSF-corrected, in dorsal anterior cingulate measured via Proton Magnetic Resonance Spectroscopy
Outcome measures
| Measure |
N-Acetylcysteine
n=10 Participants
N-Acetylcysteine: 14 day trial of N-Acetylcysteine (3g/day) followed by MRI (Day 14)
|
Placebo
n=10 Participants
Placebo: 14 day trial of matched Placebo Oral Capsule followed by MRI (Day 14)
|
|---|---|---|
|
Change in dACC GSH Levels Through Proton Magnetic Resonance Spectroscopy
|
2.426 Institutional Units
Standard Deviation 0.341
|
2.207 Institutional Units
Standard Deviation 0.423
|
Adverse Events
N-Acetylcysteine
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo Oral Tablet
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Washout
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
N-Acetylcysteine
n=12 participants at risk
N-Acetylcysteine: 14 day trial of N-acetylcysteine 3g/day
|
Placebo Oral Tablet
n=11 participants at risk
Placebo Oral Tablet: 14 day trial of matched placebo
|
Washout
n=12 participants at risk
Washout: 14 day washout period from study medications
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin Growth
|
0.00%
0/12 • Adverse Event data were collected over each participant's total study duration. This duration was a 6-week period for each participant (i.e., 2, 2-week condition periods separated by 1, 2-week washout period). Adverse event data collection took place for the entirety of the study which was 1 year.
At each study visit following the initial screening visit, study participants were assessed by the study medical doctor for any adverse events. Adverse events were recorded, rated on a severity scale, determined their relation to the study medication, and any treatment or intervention needed was discussed. The study medical doctor followed up with all previously reported adverse events at the following visits to determine if the events had ceased.
|
9.1%
1/11 • Number of events 1 • Adverse Event data were collected over each participant's total study duration. This duration was a 6-week period for each participant (i.e., 2, 2-week condition periods separated by 1, 2-week washout period). Adverse event data collection took place for the entirety of the study which was 1 year.
At each study visit following the initial screening visit, study participants were assessed by the study medical doctor for any adverse events. Adverse events were recorded, rated on a severity scale, determined their relation to the study medication, and any treatment or intervention needed was discussed. The study medical doctor followed up with all previously reported adverse events at the following visits to determine if the events had ceased.
|
0.00%
0/12 • Adverse Event data were collected over each participant's total study duration. This duration was a 6-week period for each participant (i.e., 2, 2-week condition periods separated by 1, 2-week washout period). Adverse event data collection took place for the entirety of the study which was 1 year.
At each study visit following the initial screening visit, study participants were assessed by the study medical doctor for any adverse events. Adverse events were recorded, rated on a severity scale, determined their relation to the study medication, and any treatment or intervention needed was discussed. The study medical doctor followed up with all previously reported adverse events at the following visits to determine if the events had ceased.
|
|
General disorders
Fatigue
|
8.3%
1/12 • Number of events 1 • Adverse Event data were collected over each participant's total study duration. This duration was a 6-week period for each participant (i.e., 2, 2-week condition periods separated by 1, 2-week washout period). Adverse event data collection took place for the entirety of the study which was 1 year.
At each study visit following the initial screening visit, study participants were assessed by the study medical doctor for any adverse events. Adverse events were recorded, rated on a severity scale, determined their relation to the study medication, and any treatment or intervention needed was discussed. The study medical doctor followed up with all previously reported adverse events at the following visits to determine if the events had ceased.
|
0.00%
0/11 • Adverse Event data were collected over each participant's total study duration. This duration was a 6-week period for each participant (i.e., 2, 2-week condition periods separated by 1, 2-week washout period). Adverse event data collection took place for the entirety of the study which was 1 year.
At each study visit following the initial screening visit, study participants were assessed by the study medical doctor for any adverse events. Adverse events were recorded, rated on a severity scale, determined their relation to the study medication, and any treatment or intervention needed was discussed. The study medical doctor followed up with all previously reported adverse events at the following visits to determine if the events had ceased.
|
0.00%
0/12 • Adverse Event data were collected over each participant's total study duration. This duration was a 6-week period for each participant (i.e., 2, 2-week condition periods separated by 1, 2-week washout period). Adverse event data collection took place for the entirety of the study which was 1 year.
At each study visit following the initial screening visit, study participants were assessed by the study medical doctor for any adverse events. Adverse events were recorded, rated on a severity scale, determined their relation to the study medication, and any treatment or intervention needed was discussed. The study medical doctor followed up with all previously reported adverse events at the following visits to determine if the events had ceased.
|
|
Infections and infestations
Sinus Infection
|
0.00%
0/12 • Adverse Event data were collected over each participant's total study duration. This duration was a 6-week period for each participant (i.e., 2, 2-week condition periods separated by 1, 2-week washout period). Adverse event data collection took place for the entirety of the study which was 1 year.
At each study visit following the initial screening visit, study participants were assessed by the study medical doctor for any adverse events. Adverse events were recorded, rated on a severity scale, determined their relation to the study medication, and any treatment or intervention needed was discussed. The study medical doctor followed up with all previously reported adverse events at the following visits to determine if the events had ceased.
|
0.00%
0/11 • Adverse Event data were collected over each participant's total study duration. This duration was a 6-week period for each participant (i.e., 2, 2-week condition periods separated by 1, 2-week washout period). Adverse event data collection took place for the entirety of the study which was 1 year.
At each study visit following the initial screening visit, study participants were assessed by the study medical doctor for any adverse events. Adverse events were recorded, rated on a severity scale, determined their relation to the study medication, and any treatment or intervention needed was discussed. The study medical doctor followed up with all previously reported adverse events at the following visits to determine if the events had ceased.
|
8.3%
1/12 • Number of events 1 • Adverse Event data were collected over each participant's total study duration. This duration was a 6-week period for each participant (i.e., 2, 2-week condition periods separated by 1, 2-week washout period). Adverse event data collection took place for the entirety of the study which was 1 year.
At each study visit following the initial screening visit, study participants were assessed by the study medical doctor for any adverse events. Adverse events were recorded, rated on a severity scale, determined their relation to the study medication, and any treatment or intervention needed was discussed. The study medical doctor followed up with all previously reported adverse events at the following visits to determine if the events had ceased.
|
Additional Information
James J. Prisciandaro, Ph.D.
Medical University of South Carolina
Phone: 843-792-1433
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place