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Varenicline Adjunctive Treatment in Schizophrenia

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ClinicalTrials.gov Identifier: NCT00492349
Recruitment Status : Completed
First Posted : June 27, 2007
Results First Posted : December 11, 2017
Last Update Posted : January 4, 2018
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by (Responsible Party):
L. Elliot Hong, University of Maryland

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Schizophrenia
Schizoaffective Disorder
Schizophreniform Disorder
Interventions Drug: Varenicline
Drug: Placebo
Enrollment 91
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description Varenicline Treatment Group Placebo Control Group
Period Title: Overall Study
Started 35 34
Week 2 32 33
Week 8 32 27
Completed 32 27
Not Completed 3 7
Arm/Group Title Varenicline Placebo Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 35 34 69
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 35 participants 34 participants 69 participants
Smoker 43.0  (2.5) 41.5  (2.5) 42.2  (2.5)
Non-Smoker 45.7  (2.6) 42.1  (3.2) 43.9  (2.8)
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 34 participants 69 participants
Female
12
  34.3%
10
  29.4%
22
  31.9%
Male
23
  65.7%
24
  70.6%
47
  68.1%
[1]
Measure Description: Baseline data were available for participants who completed 2 weeks in the study
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 35 participants 34 participants 69 participants
35 34 69
BPRS Total   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 35 participants 34 participants 69 participants
Smoker 36.2  (1.9) 35.0  (2.0) 35.6  (1.9)
Non-Smoker 31.2  (2.0) 34.0  (2.5) 32.6  (2.2)
[1]
Measure Description:

BRIEF PSYCHIATRIC RATING SCALE has 20 items:

1 = not present, 2 = very mild, 3 = mild, 4 = moderate, 5 = moderately severe, 6 = severe, 7 = extremely severe. Score range from 20 to 140.

Ham-D Total Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 35 participants 34 participants 69 participants
Smoker 5.0  (0.9) 5.76  (1.15) 5.38  (1.0)
Nonsmoker 5.2  (0.7) 6.6  (1.0) 5.8  (0.8)
[1]
Measure Description: HAMILTON DEPRESSION RATING SCALE In general, the higher the total score the more severe the depression. One can use the following to classify severity: 0 - 13 mild; 14-17 mild to moderate; >17 moderate to severe. However, in this trial, these categorical classifications of severity were not used. Only the raw score was used to compare between the treatment arm and the placebo arm.
1.Primary Outcome
Title Hamilton Depression Rating Scale (Ham-D)
Hide Description 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.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description:
Varenicline: Varenicline 0.5mg po qd x 7 days then titrated to Varenicline 0.5mg po bid x 7 weeks
Placebo: Placebo 0.5mg po qd x 7 days then titrated to Placebo 0.5mg po bid x 7 weeks
Overall Number of Participants Analyzed 32 27
Mean (Standard Error)
Unit of Measure: units on a scale
Smoker 22.9  (3.2) 20.6  (3.4)
Nonsmoker 19.4  (3.2) 18.6  (2.2)
2.Primary Outcome
Title Memory Saccadic Positional Error, Degrees
Hide Description A 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.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description:
Varenicline: Varenicline 0.5mg po qd x 7 days then titrated to Varenicline 0.5mg po bid x 7 weeks
Placebo: Placebo 0.5mg po qd x 7 days then titrated to Placebo 0.5mg po bid x 7 weeks
Overall Number of Participants Analyzed 32 27
Mean (Standard Error)
Unit of Measure: degrees
Smoker 1.6  (0.2) 1.7  (0.2)
Nonsmoker 1.7  (0.1) 1.8  (0.2)
3.Primary Outcome
Title Predictive Pursuit Gain
Hide Description Pursuit 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.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description:
Varenicline: Varenicline 0.5mg po qd x 7 days then titrated to Varenicline 0.5mg po bid x 7 weeks
Placebo: Placebo 0.5mg po qd x 7 days then titrated to Placebo 0.5mg po bid x 7 weeks
Overall Number of Participants Analyzed 32 27
Mean (Standard Error)
Unit of Measure: velocity ratio
Smoker 0.31  (0.03) 0.34  (0.04)
Nonsmoker 0.24  (0.04) 0.31  (0.04)
4.Primary Outcome
Title Maintenance Pursuit Gain
Hide Description Pursuit 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.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description:
Varenicline: Varenicline 0.5mg po qd x 7 days then titrated to Varenicline 0.5mg po bid x 7 weeks
Placebo: Placebo 0.5mg po qd x 7 days then titrated to Placebo 0.5mg po bid x 7 weeks
Overall Number of Participants Analyzed 32 27
Mean (Standard Error)
Unit of Measure: velocity ratio
Smoker 0.8  (0.1) 0.8  (0.04)
Nonsmoker 0.8  (0.1) 0.8  (0.1)
5.Primary Outcome
Title Digit Symbol Test
Hide Description Digit 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.
Time Frame Week 0, Week 2 and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description:

Varenicline

Varenicline: Varenicline 0.5mg po qd x 7 days then titrated to Varenicline 0.5mg po bid x 7 weeks

Placebo

Placebo: Placebo 0.5mg po qd x 7 days then titrated to Placebo 0.5mg po bid x 7 weeks

Overall Number of Participants Analyzed 28 28
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 0 53.9  (19.3) 53.2  (19.1)
Week 2 55.9  (19.0) 53.8  (20.6)
Week 8 54.2  (20.3) 54.3  (21.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Varenicline, Placebo
Comments Mixed model ANCOVA in which baseline served as the covariate and Smoking status and measurement occasions were between and within-groups factors, respectively.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
6.Primary Outcome
Title Conner's Continuous Performance Test (CPT) Detectability Score
Hide Description Conner'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.
Time Frame Week 0, Week 2 and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description:
Varenicline
Placebo
Overall Number of Participants Analyzed 30 26
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 0 0.87  (0.38) 0.87  (0.50)
Week 2 0.89  (0.42) 0.97  (0.54)
Week 8 0.95  (0.48) 0.97  (0.53)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Varenicline, Placebo
Comments Mixed model ANCOVA in which baseline CPT Detectability served as the covariate and Smoking status and measurement occasions were between and within-groups factors, respectively.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments All treatment main and interaction effect p-values were > 0.05.
Method ANCOVA
Comments [Not Specified]
7.Primary Outcome
Title Antisaccade Error Rates
Hide Description In 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.
Time Frame Week 0, Week 2 and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description:
Varenicline

Placebo

Placebo: Placebo 0.5mg po qd x 7 days then titrated to Placebo 0.5mg po bid x 7 weeks

Overall Number of Participants Analyzed 31 27
Mean (Standard Deviation)
Unit of Measure: percentage errors
Week 0 0.61  (0.27) 0.54  (0.27)
Week 2 0.49  (0.27) 0.54  (0.26)
Week 8 0.45  (0.26) 0.53  (0.28)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Varenicline, Placebo
Comments Mixed model ANCOVA in which baseline Antisaccade Errors served as the covariate and Smoking status and measurement occasions were between and within-groups factors, respectively.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
8.Primary Outcome
Title P50
Hide Description P50 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.
Time Frame Week 0, Week 2 and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description:
Varenicline
Placebo
Overall Number of Participants Analyzed 31 32
Mean (Standard Error)
Unit of Measure: microvolts
Week 0 3.2  (0.73) 3.1  (.71)
Week 2 3.2  (0.75) 3.0  (.72)
Week 8 3.2  (0.6) 2.5  (.77)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description Varenicline Placebo
All-Cause Mortality
Varenicline Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Varenicline Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/35 (0.00%)   0/34 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Varenicline Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/35 (0.00%)   0/34 (0.00%) 
The small number of nonsmokers in the placebo arm could have led to reduced power and false negatives.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: L. Elliot Hong, M.D.
Organization: University of Maryland
Phone: 410-402-6828
Responsible Party: L. Elliot Hong, University of Maryland
ClinicalTrials.gov Identifier: NCT00492349     History of Changes
Other Study ID Numbers: HP-00040322
First Submitted: June 26, 2007
First Posted: June 27, 2007
Results First Submitted: April 13, 2017
Results First Posted: December 11, 2017
Last Update Posted: January 4, 2018