Trial Outcomes & Findings for Varenicline Adjunctive Treatment in Schizophrenia (NCT NCT00492349)
NCT ID: NCT00492349
Last Updated: 2022-01-05
Results Overview
Ham-D Total Score (range 0 to 54, higher score is worse). Definition is fully described in a peer-review journal reported at Arch Gen Psychiatry 2011 Dec;68(12):1195-206.
COMPLETED
PHASE4
91 participants
Week 8
2022-01-05
Participant Flow
Participant milestones
| Measure |
Varenicline
Varenicline Treatment Group
|
Placebo
Placebo Control Group
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
34
|
|
Overall Study
Week 2
|
32
|
33
|
|
Overall Study
Week 8
|
32
|
27
|
|
Overall Study
COMPLETED
|
32
|
27
|
|
Overall Study
NOT COMPLETED
|
3
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Varenicline Adjunctive Treatment in Schizophrenia
Baseline characteristics by cohort
| Measure |
Varenicline
n=35 Participants
|
Placebo
n=34 Participants
|
Total
n=69 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Smoker
|
43.0 years
STANDARD_DEVIATION 2.5 • n=5 Participants
|
41.5 years
STANDARD_DEVIATION 2.5 • n=7 Participants
|
42.2 years
STANDARD_DEVIATION 2.5 • n=5 Participants
|
|
Age, Continuous
Non-Smoker
|
45.7 years
STANDARD_DEVIATION 2.6 • n=5 Participants
|
42.1 years
STANDARD_DEVIATION 3.2 • n=7 Participants
|
43.9 years
STANDARD_DEVIATION 2.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=5 Participants
|
34 participants
n=7 Participants
|
69 participants
n=5 Participants
|
|
BPRS Total
Smoker
|
36.2 units on a scale
STANDARD_DEVIATION 1.9 • n=5 Participants
|
35.0 units on a scale
STANDARD_DEVIATION 2.0 • n=7 Participants
|
35.6 units on a scale
STANDARD_DEVIATION 1.9 • n=5 Participants
|
|
BPRS Total
Non-Smoker
|
31.2 units on a scale
STANDARD_DEVIATION 2.0 • n=5 Participants
|
34.0 units on a scale
STANDARD_DEVIATION 2.5 • n=7 Participants
|
32.6 units on a scale
STANDARD_DEVIATION 2.2 • n=5 Participants
|
|
Ham-D Total Score
Smoker
|
5.0 units on a scale
STANDARD_DEVIATION 0.9 • n=5 Participants
|
5.76 units on a scale
STANDARD_DEVIATION 1.15 • n=7 Participants
|
5.38 units on a scale
STANDARD_DEVIATION 1.0 • n=5 Participants
|
|
Ham-D Total Score
Nonsmoker
|
5.2 units on a scale
STANDARD_DEVIATION 0.7 • n=5 Participants
|
6.6 units on a scale
STANDARD_DEVIATION 1.0 • n=7 Participants
|
5.8 units on a scale
STANDARD_DEVIATION 0.8 • n=5 Participants
|
PRIMARY outcome
Timeframe: Week 8Ham-D Total Score (range 0 to 54, higher score is worse). Definition is fully described in a peer-review journal reported at Arch Gen Psychiatry 2011 Dec;68(12):1195-206.
Outcome measures
| Measure |
Varenicline
n=32 Participants
Varenicline: Varenicline 0.5mg po qd x 7 days then titrated to Varenicline 0.5mg po bid x 7 weeks
|
Placebo
n=27 Participants
Placebo: Placebo 0.5mg po qd x 7 days then titrated to Placebo 0.5mg po bid x 7 weeks
|
|---|---|---|
|
Hamilton Depression Rating Scale (Ham-D)
Smoker
|
22.9 units on a scale
Standard Error 3.2
|
20.6 units on a scale
Standard Error 3.4
|
|
Hamilton Depression Rating Scale (Ham-D)
Nonsmoker
|
19.4 units on a scale
Standard Error 3.2
|
18.6 units on a scale
Standard Error 2.2
|
PRIMARY outcome
Timeframe: Week 8A saccade is a quick eye movement. Spatial working memory was assessed by memory saccade. Participants were asked to focus on a target while a peripheral cue was flashed. Participants were signaled to look in the direction of the peripheral cue when the central target was removed, and the positional error was calculated as the distance between the saccadic and peripheral target positions. Definition is fully described in a peer-review journal reported at Arch Gen Psychiatry 2011 Dec;68(12):1195-206.
Outcome measures
| Measure |
Varenicline
n=32 Participants
Varenicline: Varenicline 0.5mg po qd x 7 days then titrated to Varenicline 0.5mg po bid x 7 weeks
|
Placebo
n=27 Participants
Placebo: Placebo 0.5mg po qd x 7 days then titrated to Placebo 0.5mg po bid x 7 weeks
|
|---|---|---|
|
Memory Saccadic Positional Error, Degrees
Smoker
|
1.6 degrees
Standard Error 0.2
|
1.7 degrees
Standard Error 0.2
|
|
Memory Saccadic Positional Error, Degrees
Nonsmoker
|
1.7 degrees
Standard Error 0.1
|
1.8 degrees
Standard Error 0.2
|
PRIMARY outcome
Timeframe: Week 8Pursuit gain is the averaged artifact-free eye velocity divided by target velocity. Participants are asked to track a target with their eyes. Participants may use a predictive mechanism to perform the tracking. The pursuit gain using the predictive mechanism is calculated. Further definition is fully described in a peer-review journal reported at Arch Gen Psychiatry 2011 Dec;68(12):1195-206.
Outcome measures
| Measure |
Varenicline
n=32 Participants
Varenicline: Varenicline 0.5mg po qd x 7 days then titrated to Varenicline 0.5mg po bid x 7 weeks
|
Placebo
n=27 Participants
Placebo: Placebo 0.5mg po qd x 7 days then titrated to Placebo 0.5mg po bid x 7 weeks
|
|---|---|---|
|
Predictive Pursuit Gain
Smoker
|
0.31 velocity ratio
Standard Error 0.03
|
0.34 velocity ratio
Standard Error 0.04
|
|
Predictive Pursuit Gain
Nonsmoker
|
0.24 velocity ratio
Standard Error 0.04
|
0.31 velocity ratio
Standard Error 0.04
|
PRIMARY outcome
Timeframe: Week 8Pursuit gain is the averaged artifact-free eye velocity divided by target velocity. Eye velocity during the regular eye-tracking period (without foveal stabilization) divided by target velocity was used to calculate the maintenance pursuit gain. Further definition is fully described in a peer-review journal reported at Arch Gen Psychiatry 2011 Dec;68(12):1195-206.
Outcome measures
| Measure |
Varenicline
n=32 Participants
Varenicline: Varenicline 0.5mg po qd x 7 days then titrated to Varenicline 0.5mg po bid x 7 weeks
|
Placebo
n=27 Participants
Placebo: Placebo 0.5mg po qd x 7 days then titrated to Placebo 0.5mg po bid x 7 weeks
|
|---|---|---|
|
Maintenance Pursuit Gain
Smoker
|
0.8 velocity ratio
Standard Error 0.1
|
0.8 velocity ratio
Standard Error 0.04
|
|
Maintenance Pursuit Gain
Nonsmoker
|
0.8 velocity ratio
Standard Error 0.1
|
0.8 velocity ratio
Standard Error 0.1
|
PRIMARY outcome
Timeframe: Week 0, Week 2 and Week 8Digit symbol test score (0 to no definite upper range, higher score is better). Definition is fully described in a peer-review journal reported at Arch Gen Psychiatry 2011 Dec;68(12):1195-206.
Outcome measures
| Measure |
Varenicline
n=28 Participants
Varenicline: Varenicline 0.5mg po qd x 7 days then titrated to Varenicline 0.5mg po bid x 7 weeks
|
Placebo
n=28 Participants
Placebo: Placebo 0.5mg po qd x 7 days then titrated to Placebo 0.5mg po bid x 7 weeks
|
|---|---|---|
|
Digit Symbol Test
Week 0
|
53.9 units on a scale
Standard Deviation 19.3
|
53.2 units on a scale
Standard Deviation 19.1
|
|
Digit Symbol Test
Week 2
|
55.9 units on a scale
Standard Deviation 19.0
|
53.8 units on a scale
Standard Deviation 20.6
|
|
Digit Symbol Test
Week 8
|
54.2 units on a scale
Standard Deviation 20.3
|
54.3 units on a scale
Standard Deviation 21.7
|
PRIMARY outcome
Timeframe: Week 0, Week 2 and Week 8Conner's CPT Detectability Score (no set normal range, higher is generally better). Definition is fully described in a peer-review journal reported at Arch Gen Psychiatry 2011 Dec;68(12):1195-206.
Outcome measures
| Measure |
Varenicline
n=30 Participants
Varenicline: Varenicline 0.5mg po qd x 7 days then titrated to Varenicline 0.5mg po bid x 7 weeks
|
Placebo
n=26 Participants
Placebo: Placebo 0.5mg po qd x 7 days then titrated to Placebo 0.5mg po bid x 7 weeks
|
|---|---|---|
|
Conner's Continuous Performance Test (CPT) Detectability Score
Week 0
|
0.87 units on a scale
Standard Deviation 0.38
|
0.87 units on a scale
Standard Deviation 0.50
|
|
Conner's Continuous Performance Test (CPT) Detectability Score
Week 2
|
0.89 units on a scale
Standard Deviation 0.42
|
0.97 units on a scale
Standard Deviation 0.54
|
|
Conner's Continuous Performance Test (CPT) Detectability Score
Week 8
|
0.95 units on a scale
Standard Deviation 0.48
|
0.97 units on a scale
Standard Deviation 0.53
|
PRIMARY outcome
Timeframe: Week 0, Week 2 and Week 8In antisaccade, participants were asked to focus on a central target. When a peripheral cue was presented, participants were asked to look in an equidistant and opposite direction of the peripheral cue. The error rate is calculated as the number of trials in which the participant looked toward the cue, rather than in the opposite direction, divided by the total number of trials. Further definition is fully described in a peer-review journal reported at Arch Gen Psychiatry 2011 Dec;68(12):1195-206.
Outcome measures
| Measure |
Varenicline
n=31 Participants
Varenicline: Varenicline 0.5mg po qd x 7 days then titrated to Varenicline 0.5mg po bid x 7 weeks
|
Placebo
n=27 Participants
Placebo: Placebo 0.5mg po qd x 7 days then titrated to Placebo 0.5mg po bid x 7 weeks
|
|---|---|---|
|
Antisaccade Error Rates
Week 0
|
0.61 percentage errors
Standard Deviation 0.27
|
0.54 percentage errors
Standard Deviation 0.27
|
|
Antisaccade Error Rates
Week 2
|
0.49 percentage errors
Standard Deviation 0.27
|
0.54 percentage errors
Standard Deviation 0.26
|
|
Antisaccade Error Rates
Week 8
|
0.45 percentage errors
Standard Deviation 0.26
|
0.53 percentage errors
Standard Deviation 0.28
|
PRIMARY outcome
Timeframe: Week 0, Week 2 and Week 8P50 response is a measure of the amplitude of the brain wave in response to a sound, where the positive going amplitude of the brain wave occurring at about 50 milliseconds after the sound. Further definition is fully described in a peer-review journal reported at Arch Gen Psychiatry 2011 Dec;68(12):1195-206.
Outcome measures
| Measure |
Varenicline
n=31 Participants
Varenicline: Varenicline 0.5mg po qd x 7 days then titrated to Varenicline 0.5mg po bid x 7 weeks
|
Placebo
n=32 Participants
Placebo: Placebo 0.5mg po qd x 7 days then titrated to Placebo 0.5mg po bid x 7 weeks
|
|---|---|---|
|
P50
Week 2
|
3.2 microvolts
Standard Error 0.75
|
3.0 microvolts
Standard Error .72
|
|
P50
Week 0
|
3.2 microvolts
Standard Error 0.73
|
3.1 microvolts
Standard Error .71
|
|
P50
Week 8
|
3.2 microvolts
Standard Error 0.6
|
2.5 microvolts
Standard Error .77
|
Adverse Events
Varenicline
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place