Trial Outcomes & Findings for Imaging GABAergic/Glutamatergic Drugs in Bipolar Alcoholics Alcoholics (NCT NCT03220776)
NCT ID: NCT03220776
Last Updated: 2023-12-13
Results Overview
Concentrations of GABA+, referenced to unsuppressed water and corrected for within-voxel CSF proportion, in dorsal anterior cingulate cortex measured via Proton Magnetic Resonance Spectroscopy (i.e., MEGA-PRESS).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
54 participants
Primary outcome timeframe
Day 5 of each experimental condition
Results posted on
2023-12-13
Participant Flow
Participant milestones
| Measure |
Gabapentin, Washout, Then N-Acetylcysteine, Washout, Then Placebo Oral Capsule, Washout
Three, 1-week conditions.
Week 1 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (i.e., 1,200mg gabapentin) (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).
Gabapentin: 5 day trial of gabapentin with titration to 1,200mg
Week 2 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (i.e., 2,400mg N-acetylcysteine) (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).
N-Acetylcysteine: 5 day trial of N-acetylcysteine with titration to 2,400mg
Week 3 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).
Placebo Oral Tablet: 5 day trial of matched placebo
|
N-Acetylcysteine, Washout, Then Placebo Oral Capsule, Washout, Then Gabapentin, Washout
3, 1 week conditions.
Week 1 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (i.e., 2,400mg N-acetylcysteine) (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).
N-Acetylcysteine: 5 day trial of N-acetylcysteine with titration to 2,400mg
Week 2 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).
Placebo Oral Tablet: 5 day trial of matched placebo
Week 3 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (i.e., 1,200mg gabapentin) (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).
Gabapentin: 5 day trial of gabapentin with titration to 1,200mg
|
Placebo Oral Tablet, Washout, Then Gabapentin, Washout, Then N-Acetylcysteine, Washout
Three, 1-week conditions. Week 1 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).
Placebo Oral Tablet: 5 day trial of matched placebo
Week 2 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (i.e., 1,200mg gabapentin) (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).
Gabapentin: 5 day trial of gabapentin with titration to 1,200mg
Week 3 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (i.e., 2,400mg N-acetylcysteine) (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).
N-Acetylcysteine: 5 day trial of N-acetylcysteine with titration to 2,400mg
|
Placebo Oral Capsule, Washout, Then N-Acetylcysteine, Washout, Then Gabapentin, Washout
Three, 1-week conditions. Week 1 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).
Placebo Oral Tablet: 5 day trial of matched placebo Week 2 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (i.e., 2,400mg N-acetylcysteine) (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).
N-Acetylcysteine: 5 day trial of N-acetylcysteine with titration to 2,400mg Week 3 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (i.e., 1,200mg gabapentin) (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).
Gabapentin: 5 day trial of gabapentin with titration to 1,200mg
|
Gabapentin, Washout, Then Placebo Oral Capsule, Washout, Then N-Acetylcysteine, Washout
Three, 1-week conditions. Week 1 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (i.e., 1,200mg gabapentin) (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).
Gabapentin: 5 day trial of gabapentin with titration to 1,200mg Week 2 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).
Placebo Oral Tablet: 5 day trial of matched placebo Week 3 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (i.e., 2,400mg N-acetylcysteine) (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).
N-Acetylcysteine: 5 day trial of N-acetylcysteine with titration to 2,400mg
|
N-Acetylcysteine, Washout, Then Gabapentin, Washout, Then Placebo Oral Capsule, Washout
Three, 1-week conditions. Week 1 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (i.e., 2,400mg N-acetylcysteine) (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).
N-Acetylcysteine: 5 day trial of N-acetylcysteine with titration to 2,400mg
Week 2 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (i.e., 1,200mg gabapentin) (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).
Gabapentin: 5 day trial of gabapentin with titration to 1,200mg Week 3 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).
Placebo Oral Tablet: 5 day trial of matched placebo
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
9
|
9
|
9
|
9
|
9
|
|
Overall Study
COMPLETED
|
7
|
8
|
8
|
5
|
8
|
7
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
1
|
4
|
1
|
2
|
Reasons for withdrawal
| Measure |
Gabapentin, Washout, Then N-Acetylcysteine, Washout, Then Placebo Oral Capsule, Washout
Three, 1-week conditions.
Week 1 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (i.e., 1,200mg gabapentin) (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).
Gabapentin: 5 day trial of gabapentin with titration to 1,200mg
Week 2 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (i.e., 2,400mg N-acetylcysteine) (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).
N-Acetylcysteine: 5 day trial of N-acetylcysteine with titration to 2,400mg
Week 3 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).
Placebo Oral Tablet: 5 day trial of matched placebo
|
N-Acetylcysteine, Washout, Then Placebo Oral Capsule, Washout, Then Gabapentin, Washout
3, 1 week conditions.
Week 1 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (i.e., 2,400mg N-acetylcysteine) (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).
N-Acetylcysteine: 5 day trial of N-acetylcysteine with titration to 2,400mg
Week 2 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).
Placebo Oral Tablet: 5 day trial of matched placebo
Week 3 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (i.e., 1,200mg gabapentin) (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).
Gabapentin: 5 day trial of gabapentin with titration to 1,200mg
|
Placebo Oral Tablet, Washout, Then Gabapentin, Washout, Then N-Acetylcysteine, Washout
Three, 1-week conditions. Week 1 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).
Placebo Oral Tablet: 5 day trial of matched placebo
Week 2 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (i.e., 1,200mg gabapentin) (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).
Gabapentin: 5 day trial of gabapentin with titration to 1,200mg
Week 3 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (i.e., 2,400mg N-acetylcysteine) (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).
N-Acetylcysteine: 5 day trial of N-acetylcysteine with titration to 2,400mg
|
Placebo Oral Capsule, Washout, Then N-Acetylcysteine, Washout, Then Gabapentin, Washout
Three, 1-week conditions. Week 1 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).
Placebo Oral Tablet: 5 day trial of matched placebo Week 2 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (i.e., 2,400mg N-acetylcysteine) (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).
N-Acetylcysteine: 5 day trial of N-acetylcysteine with titration to 2,400mg Week 3 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (i.e., 1,200mg gabapentin) (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).
Gabapentin: 5 day trial of gabapentin with titration to 1,200mg
|
Gabapentin, Washout, Then Placebo Oral Capsule, Washout, Then N-Acetylcysteine, Washout
Three, 1-week conditions. Week 1 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (i.e., 1,200mg gabapentin) (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).
Gabapentin: 5 day trial of gabapentin with titration to 1,200mg Week 2 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).
Placebo Oral Tablet: 5 day trial of matched placebo Week 3 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (i.e., 2,400mg N-acetylcysteine) (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).
N-Acetylcysteine: 5 day trial of N-acetylcysteine with titration to 2,400mg
|
N-Acetylcysteine, Washout, Then Gabapentin, Washout, Then Placebo Oral Capsule, Washout
Three, 1-week conditions. Week 1 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (i.e., 2,400mg N-acetylcysteine) (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).
N-Acetylcysteine: 5 day trial of N-acetylcysteine with titration to 2,400mg
Week 2 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (i.e., 1,200mg gabapentin) (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).
Gabapentin: 5 day trial of gabapentin with titration to 1,200mg Week 3 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).
Placebo Oral Tablet: 5 day trial of matched placebo
|
|---|---|---|---|---|---|---|
|
Overall Study
Claustrophobia
|
0
|
1
|
1
|
0
|
1
|
0
|
|
Overall Study
MRI Equipment Failure
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Inclimate Weather
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Potential presence of non-MRI safe metal in body
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
2
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Imaging GABAergic/Glutamatergic Drugs in Bipolar Alcoholics Alcoholics
Baseline characteristics by cohort
| Measure |
Gabapentin, Then N-Acetylcysteine, Then Placebo Oral Capsule
n=9 Participants
Three, 1-week conditions.
Week 1 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (i.e., 1,200mg gabapentin) (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).
Gabapentin: 5 day trial of gabapentin with titration to 1,200mg
Week 2 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (i.e., 2,400mg N-acetylcysteine) (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).
N-Acetylcysteine: 5 day trial of N-acetylcysteine with titration to 2,400mg
Week 3 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).
Placebo Oral Tablet: 5 day trial of matched placebo
|
N-Acetylcysteine, Then Placebo Oral Capsule, Then Gabapentin
n=9 Participants
3, 1 week conditions.
Week 1 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (i.e., 2,400mg N-acetylcysteine) (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).
N-Acetylcysteine: 5 day trial of N-acetylcysteine with titration to 2,400mg
Week 2 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).
Placebo Oral Tablet: 5 day trial of matched placebo
Week 3 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (i.e., 1,200mg gabapentin) (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).
Gabapentin: 5 day trial of gabapentin with titration to 1,200mg
|
Placebo Oral Tablet, Then Gabapentin, Then N-Acetylcysteine
n=9 Participants
Three, 1-week conditions. Week 1 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).
Placebo Oral Tablet: 5 day trial of matched placebo
Week 2 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (i.e., 1,200mg gabapentin) (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).
Gabapentin: 5 day trial of gabapentin with titration to 1,200mg
Week 3 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (i.e., 2,400mg N-acetylcysteine) (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).
N-Acetylcysteine: 5 day trial of N-acetylcysteine with titration to 2,400mg
|
Placebo Oral Capsule, Then N-Acetylcysteine, Then Gabapentin
n=9 Participants
Three, 1-week conditions. Week 1 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).
Placebo Oral Tablet: 5 day trial of matched placebo Week 2 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (i.e., 2,400mg N-acetylcysteine) (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).
N-Acetylcysteine: 5 day trial of N-acetylcysteine with titration to 2,400mg Week 3 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (i.e., 1,200mg gabapentin) (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).
Gabapentin: 5 day trial of gabapentin with titration to 1,200mg
|
Gabapentin, Then Placebo Oral Capsule, Then N-Acetylcysteine
n=9 Participants
Three, 1-week conditions. Week 1 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (i.e., 1,200mg gabapentin) (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).
Gabapentin: 5 day trial of gabapentin with titration to 1,200mg Week 2 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).
Placebo Oral Tablet: 5 day trial of matched placebo Week 3 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (i.e., 2,400mg N-acetylcysteine) (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).
N-Acetylcysteine: 5 day trial of N-acetylcysteine with titration to 2,400mg
|
N-Acetylcysteine, Then Gabapentin, Then Placebo Oral Capsule
n=9 Participants
Three, 1-week conditions. Week 1 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (i.e., 2,400mg N-acetylcysteine) (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).
N-Acetylcysteine: 5 day trial of N-acetylcysteine with titration to 2,400mg
Week 2 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (i.e., 1,200mg gabapentin) (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).
Gabapentin: 5 day trial of gabapentin with titration to 1,200mg Week 3 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).
Placebo Oral Tablet: 5 day trial of matched placebo
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
54 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Age, Continuous
|
41.33 years
n=5 Participants
|
41.22 years
n=7 Participants
|
41.11 years
n=5 Participants
|
39.44 years
n=4 Participants
|
42.44 years
n=21 Participants
|
38.22 years
n=8 Participants
|
40.63 years
n=8 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
31 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
23 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
52 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
13 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
39 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
9 participants
n=7 Participants
|
9 participants
n=5 Participants
|
9 participants
n=4 Participants
|
9 participants
n=21 Participants
|
9 participants
n=8 Participants
|
54 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Day 5 of each experimental conditionPopulation: Overall number of participants analyzed includes participants who completed the entire medication condition (i.e. participants who started N-Acetylcysteine, Gabapentin, or Placebo Oral Tablet but who did not complete the MRI portion of the condition have been removed from outcome measure data analysis, but are included in other portions of this study record \[Adverse Events, Demographics, etc.\]).
Concentrations of GABA+, referenced to unsuppressed water and corrected for within-voxel CSF proportion, in dorsal anterior cingulate cortex measured via Proton Magnetic Resonance Spectroscopy (i.e., MEGA-PRESS).
Outcome measures
| Measure |
N-Acetylcysteine
n=43 Participants
Each 1-week condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (i.e., 2,400mg N-acetylcysteine) (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).
N-Acetylcysteine: 5 day trial of N-acetylcysteine with titration to 2,400mg
|
Gabapentin
n=41 Participants
Each 1-week condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (i.e., 1,200mg gabapentin) (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).
Gabapentin: 5 day trial of gabapentin with titration to 1,200mg
|
Placebo Oral Tablet
n=46 Participants
Each 1-week condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).
Placebo Oral Tablet: 5 day trial of matched placebo
|
|---|---|---|---|
|
Prefrontal GABA+ Concentrations
|
3.90 mmol/kg
Standard Deviation 0.543
|
3.93 mmol/kg
Standard Deviation 0.646
|
3.73 mmol/kg
Standard Deviation 0.705
|
PRIMARY outcome
Timeframe: Day 5 of each experimental conditionPopulation: Overall number of participants analyzed includes participants who completed the entire medication condition (i.e. participants who started N-Acetylcysteine, Gabapentin, or Placebo Oral Tablet but who did not complete the MRI portion of the condition have been removed from outcome measure data analysis, but are included in other portions of this study record \[Adverse Events, Demographics, etc.\]).
Concentrations of Glx (i.e., glutamate + glutamine), referenced to unsuppressed water and corrected for within-voxel CSF proportion, in dorsal anterior cingulate cortex measured via Proton Magnetic Resonance Spectroscopy.
Outcome measures
| Measure |
N-Acetylcysteine
n=43 Participants
Each 1-week condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (i.e., 2,400mg N-acetylcysteine) (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).
N-Acetylcysteine: 5 day trial of N-acetylcysteine with titration to 2,400mg
|
Gabapentin
n=41 Participants
Each 1-week condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (i.e., 1,200mg gabapentin) (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).
Gabapentin: 5 day trial of gabapentin with titration to 1,200mg
|
Placebo Oral Tablet
n=46 Participants
Each 1-week condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).
Placebo Oral Tablet: 5 day trial of matched placebo
|
|---|---|---|---|
|
Prefrontal Glx Concentrations
|
21.59 mmol/kg
Standard Deviation 2.518
|
21.69 mmol/kg
Standard Deviation 2.499
|
22.25 mmol/kg
Standard Deviation 2.746
|
Adverse Events
N-Acetylcysteine
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Gabapentin
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Placebo Oral Tablet
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
N-Acetylcysteine
n=48 participants at risk
N-Acetylcysteine: 5 day trial of N-acetylcysteine with titration to 2,400mg
|
Gabapentin
n=48 participants at risk
Gabapentin: 5 day trial of gabapentin with titration to 1,200mg
|
Placebo Oral Tablet
n=51 participants at risk
Placebo Oral Tablet: 5 day trial of matched placebo
|
|---|---|---|---|
|
Psychiatric disorders
insomnia
|
0.00%
0/48 • Adverse Event data were collected over each participant's total study duration. This duration was a 3-week period for each participant (i.e. 3, 1-week condition periods). Adverse event data collection took place for the entirety of the study which was 6 years.
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.
|
2.1%
1/48 • Number of events 1 • Adverse Event data were collected over each participant's total study duration. This duration was a 3-week period for each participant (i.e. 3, 1-week condition periods). Adverse event data collection took place for the entirety of the study which was 6 years.
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.
|
2.0%
1/51 • Number of events 1 • Adverse Event data were collected over each participant's total study duration. This duration was a 3-week period for each participant (i.e. 3, 1-week condition periods). Adverse event data collection took place for the entirety of the study which was 6 years.
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.
|
|
Nervous system disorders
headache
|
4.2%
2/48 • Number of events 2 • Adverse Event data were collected over each participant's total study duration. This duration was a 3-week period for each participant (i.e. 3, 1-week condition periods). Adverse event data collection took place for the entirety of the study which was 6 years.
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%
0/48 • Adverse Event data were collected over each participant's total study duration. This duration was a 3-week period for each participant (i.e. 3, 1-week condition periods). Adverse event data collection took place for the entirety of the study which was 6 years.
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.
|
2.0%
1/51 • Number of events 1 • Adverse Event data were collected over each participant's total study duration. This duration was a 3-week period for each participant (i.e. 3, 1-week condition periods). Adverse event data collection took place for the entirety of the study which was 6 years.
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.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/48 • Adverse Event data were collected over each participant's total study duration. This duration was a 3-week period for each participant (i.e. 3, 1-week condition periods). Adverse event data collection took place for the entirety of the study which was 6 years.
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.
|
6.2%
3/48 • Number of events 3 • Adverse Event data were collected over each participant's total study duration. This duration was a 3-week period for each participant (i.e. 3, 1-week condition periods). Adverse event data collection took place for the entirety of the study which was 6 years.
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.
|
3.9%
2/51 • Number of events 2 • Adverse Event data were collected over each participant's total study duration. This duration was a 3-week period for each participant (i.e. 3, 1-week condition periods). Adverse event data collection took place for the entirety of the study which was 6 years.
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
|
6.2%
3/48 • Number of events 3 • Adverse Event data were collected over each participant's total study duration. This duration was a 3-week period for each participant (i.e. 3, 1-week condition periods). Adverse event data collection took place for the entirety of the study which was 6 years.
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.
|
2.1%
1/48 • Number of events 1 • Adverse Event data were collected over each participant's total study duration. This duration was a 3-week period for each participant (i.e. 3, 1-week condition periods). Adverse event data collection took place for the entirety of the study which was 6 years.
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.
|
2.0%
1/51 • Number of events 1 • Adverse Event data were collected over each participant's total study duration. This duration was a 3-week period for each participant (i.e. 3, 1-week condition periods). Adverse event data collection took place for the entirety of the study which was 6 years.
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.
|
|
Gastrointestinal disorders
Nausea
|
2.1%
1/48 • Number of events 1 • Adverse Event data were collected over each participant's total study duration. This duration was a 3-week period for each participant (i.e. 3, 1-week condition periods). Adverse event data collection took place for the entirety of the study which was 6 years.
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.
|
2.1%
1/48 • Number of events 1 • Adverse Event data were collected over each participant's total study duration. This duration was a 3-week period for each participant (i.e. 3, 1-week condition periods). Adverse event data collection took place for the entirety of the study which was 6 years.
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%
0/51 • Adverse Event data were collected over each participant's total study duration. This duration was a 3-week period for each participant (i.e. 3, 1-week condition periods). Adverse event data collection took place for the entirety of the study which was 6 years.
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.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/48 • Adverse Event data were collected over each participant's total study duration. This duration was a 3-week period for each participant (i.e. 3, 1-week condition periods). Adverse event data collection took place for the entirety of the study which was 6 years.
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%
0/48 • Adverse Event data were collected over each participant's total study duration. This duration was a 3-week period for each participant (i.e. 3, 1-week condition periods). Adverse event data collection took place for the entirety of the study which was 6 years.
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.
|
2.0%
1/51 • Number of events 1 • Adverse Event data were collected over each participant's total study duration. This duration was a 3-week period for each participant (i.e. 3, 1-week condition periods). Adverse event data collection took place for the entirety of the study which was 6 years.
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.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
2.1%
1/48 • Number of events 1 • Adverse Event data were collected over each participant's total study duration. This duration was a 3-week period for each participant (i.e. 3, 1-week condition periods). Adverse event data collection took place for the entirety of the study which was 6 years.
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%
0/48 • Adverse Event data were collected over each participant's total study duration. This duration was a 3-week period for each participant (i.e. 3, 1-week condition periods). Adverse event data collection took place for the entirety of the study which was 6 years.
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.
|
2.0%
1/51 • Number of events 1 • Adverse Event data were collected over each participant's total study duration. This duration was a 3-week period for each participant (i.e. 3, 1-week condition periods). Adverse event data collection took place for the entirety of the study which was 6 years.
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.
|
|
Nervous system disorders
Lightheadedness
|
2.1%
1/48 • Number of events 1 • Adverse Event data were collected over each participant's total study duration. This duration was a 3-week period for each participant (i.e. 3, 1-week condition periods). Adverse event data collection took place for the entirety of the study which was 6 years.
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.
|
2.1%
1/48 • Number of events 1 • Adverse Event data were collected over each participant's total study duration. This duration was a 3-week period for each participant (i.e. 3, 1-week condition periods). Adverse event data collection took place for the entirety of the study which was 6 years.
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%
0/51 • Adverse Event data were collected over each participant's total study duration. This duration was a 3-week period for each participant (i.e. 3, 1-week condition periods). Adverse event data collection took place for the entirety of the study which was 6 years.
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.
|
|
Cardiac disorders
Dyspnea
|
0.00%
0/48 • Adverse Event data were collected over each participant's total study duration. This duration was a 3-week period for each participant (i.e. 3, 1-week condition periods). Adverse event data collection took place for the entirety of the study which was 6 years.
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%
0/48 • Adverse Event data were collected over each participant's total study duration. This duration was a 3-week period for each participant (i.e. 3, 1-week condition periods). Adverse event data collection took place for the entirety of the study which was 6 years.
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.
|
2.0%
1/51 • Number of events 1 • Adverse Event data were collected over each participant's total study duration. This duration was a 3-week period for each participant (i.e. 3, 1-week condition periods). Adverse event data collection took place for the entirety of the study which was 6 years.
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.
|
|
Psychiatric disorders
Memory Impairment
|
0.00%
0/48 • Adverse Event data were collected over each participant's total study duration. This duration was a 3-week period for each participant (i.e. 3, 1-week condition periods). Adverse event data collection took place for the entirety of the study which was 6 years.
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%
0/48 • Adverse Event data were collected over each participant's total study duration. This duration was a 3-week period for each participant (i.e. 3, 1-week condition periods). Adverse event data collection took place for the entirety of the study which was 6 years.
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.
|
2.0%
1/51 • Number of events 1 • Adverse Event data were collected over each participant's total study duration. This duration was a 3-week period for each participant (i.e. 3, 1-week condition periods). Adverse event data collection took place for the entirety of the study which was 6 years.
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.
|
|
Nervous system disorders
Somnolence
|
2.1%
1/48 • Number of events 1 • Adverse Event data were collected over each participant's total study duration. This duration was a 3-week period for each participant (i.e. 3, 1-week condition periods). Adverse event data collection took place for the entirety of the study which was 6 years.
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%
0/48 • Adverse Event data were collected over each participant's total study duration. This duration was a 3-week period for each participant (i.e. 3, 1-week condition periods). Adverse event data collection took place for the entirety of the study which was 6 years.
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%
0/51 • Adverse Event data were collected over each participant's total study duration. This duration was a 3-week period for each participant (i.e. 3, 1-week condition periods). Adverse event data collection took place for the entirety of the study which was 6 years.
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.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/48 • Adverse Event data were collected over each participant's total study duration. This duration was a 3-week period for each participant (i.e. 3, 1-week condition periods). Adverse event data collection took place for the entirety of the study which was 6 years.
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.
|
2.1%
1/48 • Number of events 1 • Adverse Event data were collected over each participant's total study duration. This duration was a 3-week period for each participant (i.e. 3, 1-week condition periods). Adverse event data collection took place for the entirety of the study which was 6 years.
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%
0/51 • Adverse Event data were collected over each participant's total study duration. This duration was a 3-week period for each participant (i.e. 3, 1-week condition periods). Adverse event data collection took place for the entirety of the study which was 6 years.
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
Irritability
|
2.1%
1/48 • Number of events 1 • Adverse Event data were collected over each participant's total study duration. This duration was a 3-week period for each participant (i.e. 3, 1-week condition periods). Adverse event data collection took place for the entirety of the study which was 6 years.
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%
0/48 • Adverse Event data were collected over each participant's total study duration. This duration was a 3-week period for each participant (i.e. 3, 1-week condition periods). Adverse event data collection took place for the entirety of the study which was 6 years.
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%
0/51 • Adverse Event data were collected over each participant's total study duration. This duration was a 3-week period for each participant (i.e. 3, 1-week condition periods). Adverse event data collection took place for the entirety of the study which was 6 years.
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.
|
|
Psychiatric disorders
Mood Swings
|
0.00%
0/48 • Adverse Event data were collected over each participant's total study duration. This duration was a 3-week period for each participant (i.e. 3, 1-week condition periods). Adverse event data collection took place for the entirety of the study which was 6 years.
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%
0/48 • Adverse Event data were collected over each participant's total study duration. This duration was a 3-week period for each participant (i.e. 3, 1-week condition periods). Adverse event data collection took place for the entirety of the study which was 6 years.
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.
|
2.0%
1/51 • Number of events 1 • Adverse Event data were collected over each participant's total study duration. This duration was a 3-week period for each participant (i.e. 3, 1-week condition periods). Adverse event data collection took place for the entirety of the study which was 6 years.
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.
|
|
Psychiatric disorders
Dissociation
|
2.1%
1/48 • Number of events 1 • Adverse Event data were collected over each participant's total study duration. This duration was a 3-week period for each participant (i.e. 3, 1-week condition periods). Adverse event data collection took place for the entirety of the study which was 6 years.
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%
0/48 • Adverse Event data were collected over each participant's total study duration. This duration was a 3-week period for each participant (i.e. 3, 1-week condition periods). Adverse event data collection took place for the entirety of the study which was 6 years.
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%
0/51 • Adverse Event data were collected over each participant's total study duration. This duration was a 3-week period for each participant (i.e. 3, 1-week condition periods). Adverse event data collection took place for the entirety of the study which was 6 years.
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.
|
|
Gastrointestinal disorders
Teeth Grinding
|
0.00%
0/48 • Adverse Event data were collected over each participant's total study duration. This duration was a 3-week period for each participant (i.e. 3, 1-week condition periods). Adverse event data collection took place for the entirety of the study which was 6 years.
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.
|
2.1%
1/48 • Number of events 1 • Adverse Event data were collected over each participant's total study duration. This duration was a 3-week period for each participant (i.e. 3, 1-week condition periods). Adverse event data collection took place for the entirety of the study which was 6 years.
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%
0/51 • Adverse Event data were collected over each participant's total study duration. This duration was a 3-week period for each participant (i.e. 3, 1-week condition periods). Adverse event data collection took place for the entirety of the study which was 6 years.
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.
|
|
Gastrointestinal disorders
Vomiting
|
2.1%
1/48 • Number of events 1 • Adverse Event data were collected over each participant's total study duration. This duration was a 3-week period for each participant (i.e. 3, 1-week condition periods). Adverse event data collection took place for the entirety of the study which was 6 years.
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%
0/48 • Adverse Event data were collected over each participant's total study duration. This duration was a 3-week period for each participant (i.e. 3, 1-week condition periods). Adverse event data collection took place for the entirety of the study which was 6 years.
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%
0/51 • Adverse Event data were collected over each participant's total study duration. This duration was a 3-week period for each participant (i.e. 3, 1-week condition periods). Adverse event data collection took place for the entirety of the study which was 6 years.
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.
|
|
Injury, poisoning and procedural complications
Skin Abrasion
|
2.1%
1/48 • Number of events 1 • Adverse Event data were collected over each participant's total study duration. This duration was a 3-week period for each participant (i.e. 3, 1-week condition periods). Adverse event data collection took place for the entirety of the study which was 6 years.
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%
0/48 • Adverse Event data were collected over each participant's total study duration. This duration was a 3-week period for each participant (i.e. 3, 1-week condition periods). Adverse event data collection took place for the entirety of the study which was 6 years.
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%
0/51 • Adverse Event data were collected over each participant's total study duration. This duration was a 3-week period for each participant (i.e. 3, 1-week condition periods). Adverse event data collection took place for the entirety of the study which was 6 years.
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.
|
|
Skin and subcutaneous tissue disorders
Skin Odor
|
2.1%
1/48 • Number of events 1 • Adverse Event data were collected over each participant's total study duration. This duration was a 3-week period for each participant (i.e. 3, 1-week condition periods). Adverse event data collection took place for the entirety of the study which was 6 years.
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%
0/48 • Adverse Event data were collected over each participant's total study duration. This duration was a 3-week period for each participant (i.e. 3, 1-week condition periods). Adverse event data collection took place for the entirety of the study which was 6 years.
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%
0/51 • Adverse Event data were collected over each participant's total study duration. This duration was a 3-week period for each participant (i.e. 3, 1-week condition periods). Adverse event data collection took place for the entirety of the study which was 6 years.
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.
|
|
Gastrointestinal disorders
Constipation
|
2.1%
1/48 • Number of events 1 • Adverse Event data were collected over each participant's total study duration. This duration was a 3-week period for each participant (i.e. 3, 1-week condition periods). Adverse event data collection took place for the entirety of the study which was 6 years.
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%
0/48 • Adverse Event data were collected over each participant's total study duration. This duration was a 3-week period for each participant (i.e. 3, 1-week condition periods). Adverse event data collection took place for the entirety of the study which was 6 years.
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%
0/51 • Adverse Event data were collected over each participant's total study duration. This duration was a 3-week period for each participant (i.e. 3, 1-week condition periods). Adverse event data collection took place for the entirety of the study which was 6 years.
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.
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease (GERD)
|
2.1%
1/48 • Number of events 1 • Adverse Event data were collected over each participant's total study duration. This duration was a 3-week period for each participant (i.e. 3, 1-week condition periods). Adverse event data collection took place for the entirety of the study which was 6 years.
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%
0/48 • Adverse Event data were collected over each participant's total study duration. This duration was a 3-week period for each participant (i.e. 3, 1-week condition periods). Adverse event data collection took place for the entirety of the study which was 6 years.
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%
0/51 • Adverse Event data were collected over each participant's total study duration. This duration was a 3-week period for each participant (i.e. 3, 1-week condition periods). Adverse event data collection took place for the entirety of the study which was 6 years.
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