Trial Outcomes & Findings for Comparison of Varenicline and Placebo for Smoking Cessation in Schizophrenia (NCT NCT00554840)
NCT ID: NCT00554840
Last Updated: 2022-03-18
Results Overview
End expired carbon monoxide (CO) level change from baseline to determine participants' level of smoking reduction by treatment assignment. Larger negative values represent a greater level of smoking reduction.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
Weekly for 12 weeks
Results posted on
2022-03-18
Participant Flow
Stable outpatients who received their regular treatment at the Outpatient Research Program of the MPRC were invited to participate.
After the enrollment of 16 participants, a total of 7 participants were withdrawn from the study prior to assignment to a treatment group (n=9). Two subjects met exclusion criteria before any study procedures were started, and 5 subjects were withdrawn during either the "evaluation" or "pre-med" phases of the study.
Participant milestones
| Measure |
Varenicline
varenicline: Subjects will be randomized to receive either active drug or matching placebo capsules using the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase. Subjects will be evaluated weekly for abstinence through self report, end expired CO and urine dipstick for cotinine.
|
Placebo
placebo: At the end of Pre-med week 1, subjects will receive study medication with the target quit date being the following week. Subjects will be randomized to receive either active drug or matching placebo capsules using the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase. Subjects will be evaluated weekly for abstinence through self report, end expired CO and urine dipstick for cotinine.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
5
|
|
Overall Study
COMPLETED
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Varenicline
varenicline: Subjects will be randomized to receive either active drug or matching placebo capsules using the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase. Subjects will be evaluated weekly for abstinence through self report, end expired CO and urine dipstick for cotinine.
|
Placebo
placebo: At the end of Pre-med week 1, subjects will receive study medication with the target quit date being the following week. Subjects will be randomized to receive either active drug or matching placebo capsules using the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase. Subjects will be evaluated weekly for abstinence through self report, end expired CO and urine dipstick for cotinine.
|
|---|---|---|
|
Overall Study
Physician Decision
|
0
|
1
|
Baseline Characteristics
Comparison of Varenicline and Placebo for Smoking Cessation in Schizophrenia
Baseline characteristics by cohort
| Measure |
Varenicline
n=4 Participants
varenicline: Subjects will be randomized to receive either active drug or matching placebo capsules using the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase. Subjects will be evaluated weekly for abstinence through self report, end expired CO and urine dipstick for cotinine.
|
Placebo
n=4 Participants
placebo: At the end of Pre-med week 1, subjects will receive study medication with the target quit date being the following week. Subjects will be randomized to receive either active drug or matching placebo capsules using the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase. Subjects will be evaluated weekly for abstinence through self report, end expired CO and urine dipstick for cotinine.
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
8 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Continuous
|
46.3 years
STANDARD_DEVIATION 9.0 • n=39 Participants
|
44.3 years
STANDARD_DEVIATION 5.1 • n=41 Participants
|
45.97 years
STANDARD_DEVIATION 6.87 • n=35 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
6 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
6 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=39 Participants
|
4 participants
n=41 Participants
|
8 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Weekly for 12 weeksPopulation: Some ExpiredCO data is missing due to rater error or participant absence from that study visit.
End expired carbon monoxide (CO) level change from baseline to determine participants' level of smoking reduction by treatment assignment. Larger negative values represent a greater level of smoking reduction.
Outcome measures
| Measure |
Varenicline
n=4 Participants
Subjects randomized to active treatment (varenicline) will use the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase.
|
Placebo
n=4 Participants
Subjects randomized to matching placebo capsules will use the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase.
|
|---|---|---|
|
Change of ExpiredCO Level From Baseline
Treatment Week 1
|
-2.88 ppm
Standard Deviation 8.35
|
9.5 ppm
Standard Deviation 6.54
|
|
Change of ExpiredCO Level From Baseline
Treatment Week 2
|
-17.38 ppm
Standard Deviation 22.21
|
-11.5 ppm
Standard Deviation 6.94
|
|
Change of ExpiredCO Level From Baseline
Treatment Week 3
|
-17.13 ppm
Standard Deviation 23.59
|
-5.75 ppm
Standard Deviation 2.40
|
|
Change of ExpiredCO Level From Baseline
Treatment Week 4
|
-18.63 ppm
Standard Deviation 20.77
|
2.5 ppm
Standard Deviation 4.10
|
|
Change of ExpiredCO Level From Baseline
Treatment Week 5
|
-20.63 ppm
Standard Deviation 20.27
|
-4.5 ppm
Standard Deviation 4.02
|
|
Change of ExpiredCO Level From Baseline
Treatment Week 6
|
-20.38 ppm
Standard Deviation 20.55
|
-3.83 ppm
Standard Deviation 7.25
|
|
Change of ExpiredCO Level From Baseline
Treatment Week 7
|
-20.13 ppm
Standard Deviation 20.46
|
-2.83 ppm
Standard Deviation 7.11
|
|
Change of ExpiredCO Level From Baseline
Treatment Week 8
|
-20.88 ppm
Standard Deviation 19.28
|
-4.83 ppm
Standard Deviation 8.40
|
|
Change of ExpiredCO Level From Baseline
Treatment Week 9
|
-20.88 ppm
Standard Deviation 19.98
|
-0.17 ppm
Standard Deviation 12.55
|
|
Change of ExpiredCO Level From Baseline
Treatment Week 10
|
-21.13 ppm
Standard Deviation 19.38
|
-2.83 ppm
Standard Deviation 9.78
|
|
Change of ExpiredCO Level From Baseline
Treatment Week 11
|
-19.63 ppm
Standard Deviation 20.72
|
8.17 ppm
Standard Deviation 17.19
|
|
Change of ExpiredCO Level From Baseline
Treatment Week 12
|
-19.875 ppm
Standard Deviation 18.98
|
-0.75 ppm
Standard Deviation 6.64
|
PRIMARY outcome
Timeframe: Weekly for 12 weeksPopulation: Some FTND data is missing due to rater error or participant absence from that study visit.
Nicotine dependence was measured using the total score from the Fagerstrom Test for Nicotine Dependence (FTND) assessment. The total score is computed by adding the scores from the five subscales. Total scores range from 1-10, with lower scores representing a smaller degree of nicotine dependence.
Outcome measures
| Measure |
Varenicline
n=4 Participants
Subjects randomized to active treatment (varenicline) will use the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase.
|
Placebo
n=4 Participants
Subjects randomized to matching placebo capsules will use the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase.
|
|---|---|---|
|
Level of Nicotine Dependence by Treatment Assignment
Treatment Week 0
|
5.88 units on a scale
Standard Deviation 1.31
|
5.75 units on a scale
Standard Deviation 2.10
|
|
Level of Nicotine Dependence by Treatment Assignment
Treatment Week 1
|
4.5 units on a scale
Standard Deviation 1.30
|
5.25 units on a scale
Standard Deviation 2.06
|
|
Level of Nicotine Dependence by Treatment Assignment
Treatment Week 2
|
4.33 units on a scale
Standard Deviation 0.58
|
4.75 units on a scale
Standard Deviation 2.06
|
|
Level of Nicotine Dependence by Treatment Assignment
Treatment Week 3
|
3 units on a scale
Standard Deviation 3
|
4.5 units on a scale
Standard Deviation 1.91
|
|
Level of Nicotine Dependence by Treatment Assignment
Treatment Week 4
|
3 units on a scale
Standard Deviation 3
|
5 units on a scale
Standard Deviation 1.83
|
|
Level of Nicotine Dependence by Treatment Assignment
Treatment Week 5
|
2.75 units on a scale
Standard Deviation 2.22
|
5.25 units on a scale
Standard Deviation 1.71
|
|
Level of Nicotine Dependence by Treatment Assignment
Treatment Week 6
|
4.25 units on a scale
Standard Deviation 1.71
|
4.33 units on a scale
Standard Deviation 1.53
|
|
Level of Nicotine Dependence by Treatment Assignment
Treatment Week 7
|
4.5 units on a scale
Standard Deviation 1.73
|
4.67 units on a scale
Standard Deviation 1.53
|
|
Level of Nicotine Dependence by Treatment Assignment
Treatment Week 8
|
4.75 units on a scale
Standard Deviation 1.89
|
4 units on a scale
Standard Deviation 1.73
|
|
Level of Nicotine Dependence by Treatment Assignment
Treatment Week 9
|
5 units on a scale
Standard Deviation 2.16
|
3.67 units on a scale
Standard Deviation 2.08
|
|
Level of Nicotine Dependence by Treatment Assignment
Treatment Week 10
|
5 units on a scale
Standard Deviation 2
|
3.67 units on a scale
Standard Deviation 2.08
|
|
Level of Nicotine Dependence by Treatment Assignment
Treatment Week 11
|
6 units on a scale
Standard Deviation 1
|
4.33 units on a scale
Standard Deviation 1.53
|
|
Level of Nicotine Dependence by Treatment Assignment
Treatment Week 12
|
3.5 units on a scale
Standard Deviation 3.11
|
4.25 units on a scale
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: Baseline (week 0) then again during the Treatment Phase at weeks 1, 2, 4, 8, and 12.Population: Some BPRS total score data is missing due to rater error or participant absence from that study visit.
The total BPRS score is calculated by adding the scores for subscales #1-#18. Each scale ranges from "1=Not Present" to "7=Very Severe". Total scores range from a minimum score of 18 to a maximum score of 126. A higher total score indicates a more severe psychiatric symptom rating.
Outcome measures
| Measure |
Varenicline
n=4 Participants
Subjects randomized to active treatment (varenicline) will use the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase.
|
Placebo
n=4 Participants
Subjects randomized to matching placebo capsules will use the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase.
|
|---|---|---|
|
Brief Psychiatric Rating Scale (BPRS) - Total Score
Baseline
|
35.75 units on a scale
Standard Deviation 6.34
|
30.25 units on a scale
Standard Deviation 4.11
|
|
Brief Psychiatric Rating Scale (BPRS) - Total Score
Treatment Week 1
|
33.75 units on a scale
Standard Deviation 5.56
|
32.75 units on a scale
Standard Deviation 6.6
|
|
Brief Psychiatric Rating Scale (BPRS) - Total Score
Treatment Week 2
|
35.5 units on a scale
Standard Deviation 7
|
30.25 units on a scale
Standard Deviation 4.35
|
|
Brief Psychiatric Rating Scale (BPRS) - Total Score
Treatment Week 4
|
31.75 units on a scale
Standard Deviation 3.4
|
30.25 units on a scale
Standard Deviation 6.75
|
|
Brief Psychiatric Rating Scale (BPRS) - Total Score
Treatment Week 8
|
36.25 units on a scale
Standard Deviation 4.27
|
28 units on a scale
Standard Deviation 2.65
|
|
Brief Psychiatric Rating Scale (BPRS) - Total Score
Treatment Week 12
|
34.75 units on a scale
Standard Deviation 3.30
|
32 units on a scale
Standard Deviation 3.92
|
SECONDARY outcome
Timeframe: Baseline (week 0) then again during the Treatment Phase at weeks 1, 2, 4, 8, and 12.Population: Some BPRS total score data is missing due to rater error or participant absence from that study visit.
The psychosis score is calculated by adding the scores for scales #4 Conceptual Disorganization, #11 Suspiciousness, #12 Hallucinatory Behavior, and #15 Unusual Thought Content. Each scale ranges from "1=Not Present" to "7=Very Severe". The minimum psychosis score is 4 and the maximum psychosis score is 28. A higher score indicates a more severe psychosis rating.
Outcome measures
| Measure |
Varenicline
n=4 Participants
Subjects randomized to active treatment (varenicline) will use the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase.
|
Placebo
n=4 Participants
Subjects randomized to matching placebo capsules will use the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase.
|
|---|---|---|
|
Brief Psychiatric Rating Scale (BPRS) - Psychosis Score
Baseline
|
11.25 units on a scale
Standard Deviation 2.22
|
10 units on a scale
Standard Deviation 5.94
|
|
Brief Psychiatric Rating Scale (BPRS) - Psychosis Score
Treatment Week 1
|
8.5 units on a scale
Standard Deviation 3.12
|
11.5 units on a scale
Standard Deviation 6.03
|
|
Brief Psychiatric Rating Scale (BPRS) - Psychosis Score
Treatment Week 2
|
9.25 units on a scale
Standard Deviation 4.03
|
8.5 units on a scale
Standard Deviation 4.51
|
|
Brief Psychiatric Rating Scale (BPRS) - Psychosis Score
Treatment Week 4
|
8.25 units on a scale
Standard Deviation 4.03
|
8.5 units on a scale
Standard Deviation 4.65
|
|
Brief Psychiatric Rating Scale (BPRS) - Psychosis Score
Treatment Week 8
|
10.75 units on a scale
Standard Deviation 3.3
|
7.67 units on a scale
Standard Deviation 1.53
|
|
Brief Psychiatric Rating Scale (BPRS) - Psychosis Score
Treatment Week 12
|
8.75 units on a scale
Standard Deviation 2.22
|
10.5 units on a scale
Standard Deviation 3.87
|
SECONDARY outcome
Timeframe: Baseline (week 0) then again during the Treatment Phase at weeks 1, 2, 4, 8, and 12.Population: Some BPRS anxiety/depression score data is missing due to rater error or participant absence from that study visit.
The anxiety/depression score is calculated by adding the scores for scales #2 Anxiety and #9 Depressive Mood. Each scale ranges from "1=Not Present" to "7=Very Severe". The minimum anxiety/depression score is 2 and the maximum psychosis score is 14. A higher score indicates a more severe anxiety/depression rating.
Outcome measures
| Measure |
Varenicline
n=4 Participants
Subjects randomized to active treatment (varenicline) will use the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase.
|
Placebo
n=4 Participants
Subjects randomized to matching placebo capsules will use the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase.
|
|---|---|---|
|
Brief Psychiatric Rating Scale (BPRS) - Anxiety/Depression Score
Baseline
|
5.5 units on a scale
Standard Deviation 1.3
|
6.75 units on a scale
Standard Deviation 2.06
|
|
Brief Psychiatric Rating Scale (BPRS) - Anxiety/Depression Score
Treatment Week 1
|
3.25 units on a scale
Standard Deviation 0.96
|
8 units on a scale
Standard Deviation 3.27
|
|
Brief Psychiatric Rating Scale (BPRS) - Anxiety/Depression Score
Treatment Week 2
|
7.25 units on a scale
Standard Deviation 1.71
|
7.25 units on a scale
Standard Deviation 2.99
|
|
Brief Psychiatric Rating Scale (BPRS) - Anxiety/Depression Score
Treatment Week 4
|
6.25 units on a scale
Standard Deviation 1.71
|
8 units on a scale
Standard Deviation 4.32
|
|
Brief Psychiatric Rating Scale (BPRS) - Anxiety/Depression Score
Treatment Week 8
|
7.25 units on a scale
Standard Deviation 0.5
|
3.37 units on a scale
Standard Deviation 2.52
|
|
Brief Psychiatric Rating Scale (BPRS) - Anxiety/Depression Score
Treatment Week 12
|
7 units on a scale
Standard Deviation 1.41
|
7.5 units on a scale
Standard Deviation 2.65
|
SECONDARY outcome
Timeframe: Weekly for 12 weeksSide effects (33 items) were measured using a Side Effects Checklist (SEC). The percentage of participants endorsing each side effect were reported regardless of the severity or relation to study drug.
Outcome measures
| Measure |
Varenicline
n=4 Participants
Subjects randomized to active treatment (varenicline) will use the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase.
|
Placebo
n=4 Participants
Subjects randomized to matching placebo capsules will use the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase.
|
|---|---|---|
|
Side Effects
Abdominal pain
|
1 Participants
|
4 Participants
|
|
Side Effects
Anorexia
|
0 Participants
|
1 Participants
|
|
Side Effects
Bruising
|
0 Participants
|
0 Participants
|
|
Side Effects
Constipation
|
2 Participants
|
0 Participants
|
|
Side Effects
Diarrhea
|
1 Participants
|
0 Participants
|
|
Side Effects
Dizziness
|
1 Participants
|
2 Participants
|
|
Side Effects
Dry mouth
|
0 Participants
|
2 Participants
|
|
Side Effects
Enuresis
|
0 Participants
|
2 Participants
|
|
Side Effects
Fever
|
0 Participants
|
0 Participants
|
|
Side Effects
Headache
|
1 Participants
|
1 Participants
|
|
Side Effects
Insomnia
|
3 Participants
|
1 Participants
|
|
Side Effects
Malaise
|
2 Participants
|
1 Participants
|
|
Side Effects
Mucosal ulceration
|
0 Participants
|
0 Participants
|
|
Side Effects
Nausea
|
3 Participants
|
1 Participants
|
|
Side Effects
Rash
|
1 Participants
|
1 Participants
|
|
Side Effects
Restlessness
|
0 Participants
|
1 Participants
|
|
Side Effects
Hypersalivation
|
3 Participants
|
1 Participants
|
|
Side Effects
Sedation
|
2 Participants
|
2 Participants
|
|
Side Effects
Stiffness
|
0 Participants
|
1 Participants
|
|
Side Effects
Sore throat
|
1 Participants
|
1 Participants
|
|
Side Effects
Tremor
|
0 Participants
|
1 Participants
|
|
Side Effects
Uticaria
|
1 Participants
|
1 Participants
|
|
Side Effects
Vomiting
|
0 Participants
|
1 Participants
|
|
Side Effects
Weight loss
|
1 Participants
|
0 Participants
|
|
Side Effects
Tinnitus
|
0 Participants
|
0 Participants
|
Adverse Events
Varenicline
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Varenicline
n=4 participants at risk
Subjects randomized to receive active drug (varenicline) will have the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase.
|
Placebo
n=4 participants at risk
Subjects randomized to matching placebo will have the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase.
|
|---|---|---|
|
Psychiatric disorders
Hospitalization
|
0.00%
0/4 • Adverse event data was collected for each participant for their entire duration of the study (up to 20 weeks).
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected for each participant for their entire duration of the study (up to 20 weeks).
|
Other adverse events
| Measure |
Varenicline
n=4 participants at risk
Subjects randomized to receive active drug (varenicline) will have the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase.
|
Placebo
n=4 participants at risk
Subjects randomized to matching placebo will have the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase.
|
|---|---|---|
|
Ear and labyrinth disorders
Dizziness
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected for each participant for their entire duration of the study (up to 20 weeks).
|
0.00%
0/4 • Adverse event data was collected for each participant for their entire duration of the study (up to 20 weeks).
|
|
General disorders
Headache
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected for each participant for their entire duration of the study (up to 20 weeks).
|
0.00%
0/4 • Adverse event data was collected for each participant for their entire duration of the study (up to 20 weeks).
|
|
General disorders
Dry mouth
|
0.00%
0/4 • Adverse event data was collected for each participant for their entire duration of the study (up to 20 weeks).
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected for each participant for their entire duration of the study (up to 20 weeks).
|
|
Skin and subcutaneous tissue disorders
Rash
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected for each participant for their entire duration of the study (up to 20 weeks).
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected for each participant for their entire duration of the study (up to 20 weeks).
|
|
Hepatobiliary disorders
Elevated liver enzymes
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected for each participant for their entire duration of the study (up to 20 weeks).
|
0.00%
0/4 • Adverse event data was collected for each participant for their entire duration of the study (up to 20 weeks).
|
|
General disorders
Malaise
|
25.0%
1/4 • Number of events 3 • Adverse event data was collected for each participant for their entire duration of the study (up to 20 weeks).
|
0.00%
0/4 • Adverse event data was collected for each participant for their entire duration of the study (up to 20 weeks).
|
|
General disorders
Abdominal pain
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected for each participant for their entire duration of the study (up to 20 weeks).
|
0.00%
0/4 • Adverse event data was collected for each participant for their entire duration of the study (up to 20 weeks).
|
Additional Information
Elaine Weiner, M.D.
Maryland Psychiatric Research Center
Phone: 410-402-7694
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place