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Trial record 59 of 111 for:    "Depressive Disorder" [DISEASE] AND Behavioral AND Mental | ( Map: Spain )

Safety And Efficacy Of 12 Weeks Of Varenicline For Smoking Cessation In Smokers With Depression

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ClinicalTrials.gov Identifier: NCT01078298
Recruitment Status : Completed
First Posted : March 2, 2010
Results First Posted : April 16, 2013
Last Update Posted : April 16, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Smoking Cessation
Depression
Interventions Drug: varenicline
Drug: placebo
Enrollment 525
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description Varenicline 0.5 milligram (mg) tablet given orally once daily up to Day 3 followed by varenicline 0.5 mg tablet orally twice daily up to Day 7 and then varenicline 1 mg tablet given orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment. Placebo matched to varenicline 0.5 mg tablet orally once daily up to Day 3 followed by placebo matched to varenicline 0.5 mg tablet orally twice daily up to Day 7 and then placebo matched to varenicline 1 mg tablet orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
Period Title: Overall Study
Started 256 269
Completed 175 179
Not Completed 81 90
Reason Not Completed
Lost to Follow-up             12             13
Withdrawal by Subject             31             33
Protocol Violation             6             6
Adverse Event             6             5
Death             2             0
Did not meet entrance criteria             0             1
Other             24             32
Arm/Group Title Varenicline Placebo Total
Hide Arm/Group Description Varenicline 0.5 milligram (mg) tablet given orally once daily up to Day 3 followed by varenicline 0.5 mg tablet orally twice daily up to Day 7 and then varenicline 1 mg tablet given orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment. Placebo matched to varenicline 0.5 mg tablet orally once daily up to Day 3 followed by placebo matched to varenicline 0.5 mg tablet orally twice daily up to Day 7 and then placebo matched to varenicline 1 mg tablet orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment. Total of all reporting groups
Overall Number of Baseline Participants 256 269 525
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 256 participants 269 participants 525 participants
18 to 44 years 106 98 204
45 to 64 years 146 160 306
Greater than or equal to 65 years 4 11 15
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 256 participants 269 participants 525 participants
Female
159
  62.1%
170
  63.2%
329
  62.7%
Male
97
  37.9%
99
  36.8%
196
  37.3%
1.Primary Outcome
Title Percentage of Participants With a Four-Week Continuous Quit Rate (CQR)
Hide Description Percentage of participants who reported no use of nicotine-containing products by answering "No" to the nicotine use inventory (NUI) questions: ‘Has the participant smoked cigarettes’ and ‘Has the participant used other nicotine-containing products’ in the last 7 days (Week 9) or since last study visit (Week 9 through 12) confirmed by a measurement of an end-expiratory exhaled carbon monoxide (CO) measurement less than or equal to 10 parts per million (ppm).
Time Frame Week 9 through Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All participants analysis set included all the participants who were randomized and took at least one dose of randomized study medication.
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description:
Varenicline 0.5 milligram (mg) tablet given orally once daily up to Day 3 followed by varenicline 0.5 mg tablet orally twice daily up to Day 7 and then varenicline 1 mg tablet given orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
Placebo matched to varenicline 0.5 mg tablet orally once daily up to Day 3 followed by placebo matched to varenicline 0.5 mg tablet orally twice daily up to Day 7 and then placebo matched to varenicline 1 mg tablet orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
Overall Number of Participants Analyzed 256 269
Measure Type: Number
Unit of Measure: Percentage of participants
35.9 15.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Varenicline, Placebo
Comments Odds Ratios and p-values were obtained from a logistic regression model including the main effects of treatment, pooled center and cohort.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.35
Confidence Interval (2-Sided) 95%
2.16 to 5.21
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With Continuous Abstinence Rate (CAR)
Hide Description Percentage of participants who remained abstinent from the period defined as start of the primary endpoint (Week 9) through Week 24 and the end of follow-up (Week 52) by reporting no use of nicotine-containing products confirmed by a measurement of an end-expiratory exhaled CO measurement less than or equal to 10 ppm.
Time Frame Week 9 through Week 24, Week 9 through Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
All participants analysis set included all the participants who were randomized and took at least one dose of randomized study medication.
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description:
Varenicline 0.5 milligram (mg) tablet given orally once daily up to Day 3 followed by varenicline 0.5 mg tablet orally twice daily up to Day 7 and then varenicline 1 mg tablet given orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
Placebo matched to varenicline 0.5 mg tablet orally once daily up to Day 3 followed by placebo matched to varenicline 0.5 mg tablet orally twice daily up to Day 7 and then placebo matched to varenicline 1 mg tablet orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
Overall Number of Participants Analyzed 256 269
Measure Type: Number
Unit of Measure: Percentage of participants
Week 9 through Week 24 25.0 12.3
Week 9 through Week 52 20.3 10.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Varenicline, Placebo
Comments For Week 9 through 24, odds ratio and p-value were calculated from logistic regression model including the main effects of treatment, pooled center and cohort.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.53
Confidence Interval (2-Sided) 95%
1.56 to 4.10
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Varenicline, Placebo
Comments For Week 9 through 52, odds ratio and p-value were calculated from logistic regression model including the main effects of treatment, pooled center and cohort.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0011
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.36
Confidence Interval (2-Sided) 95%
1.40 to 3.98
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants With 7-day Point Prevalence (PP) of Abstinence
Hide Description Number of participants reporting no use of nicotine-containing products in the last 7 days confirmed by a measurement of an end-expiratory exhaled CO measurement less than or equal to 10 ppm.
Time Frame Weeks 12, 24, 52
Hide Outcome Measure Data
Hide Analysis Population Description
All participants analysis set included all the participants who were randomized and took at least one dose of randomized study medication.
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description:
Varenicline 0.5 milligram (mg) tablet given orally once daily up to Day 3 followed by varenicline 0.5 mg tablet orally twice daily up to Day 7 and then varenicline 1 mg tablet given orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
Placebo matched to varenicline 0.5 mg tablet orally once daily up to Day 3 followed by placebo matched to varenicline 0.5 mg tablet orally twice daily up to Day 7 and then placebo matched to varenicline 1 mg tablet orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
Overall Number of Participants Analyzed 256 269
Measure Type: Number
Unit of Measure: participants
Week 12 118 54
Week 24 80 49
Week 52 73 47
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Varenicline, Placebo
Comments For Week 12, odds ratio and p-values were obtained from a logistic regression model including the main effects of treatment, pooled center and cohort.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.82
Confidence Interval (2-Sided) 95%
2.53 to 5.78
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Varenicline, Placebo
Comments For Week 24, odds ratio and p-values were obtained from a logistic regression model including the main effects of treatment, pooled center and cohort.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0004
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.16
Confidence Interval (2-Sided) 95%
1.40 to 3.33
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Varenicline, Placebo
Comments For Week 52, odds ratio and p-values were obtained from a logistic regression model including the main effects of treatment, pooled center and cohort.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0020
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.98
Confidence Interval (2-Sided) 95%
1.28 to 3.08
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Number of Participants With 4-Week Point Prevalence (PP) of Abstinence
Hide Description Number of participants at Week 52 visit reporting no smoking and no use of other tobacco products in the last 4 weeks confirmed by a measurement of an end-expiratory exhaled CO measurement less than or equal to 10 ppm.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
All participants analysis set included all the participants who were randomized and took at least one dose of randomized study medication.
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description:
Varenicline 0.5 milligram (mg) tablet given orally once daily up to Day 3 followed by varenicline 0.5 mg tablet orally twice daily up to Day 7 and then varenicline 1 mg tablet given orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
Placebo matched to varenicline 0.5 mg tablet orally once daily up to Day 3 followed by placebo matched to varenicline 0.5 mg tablet orally twice daily up to Day 7 and then placebo matched to varenicline 1 mg tablet orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
Overall Number of Participants Analyzed 256 269
Measure Type: Number
Unit of Measure: participants
70 45
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Varenicline, Placebo
Comments Odds Ratios and p-values were obtained from a logistic regression model including the main effects of treatment, pooled center and cohort.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0027
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.97
Confidence Interval (2-Sided) 95%
1.26 to 3.08
Estimation Comments [Not Specified]
5.Other Pre-specified Outcome
Title Number of Participants With Adverse Events (Including Solicited Neuropsychiatric Adverse Events)
Hide Description Adverse Event (AE):any untoward medical occurrence attributed to study drug in participant who received study drug.SAE:AE causing:death;initial/prolonged inpatient hospitalization;life-threatening experience(immediate risk of dying);persistent/significant disability/incapacity;congenital anomaly.Solicited AEs collected by semi-structured neuropsychiatric AEs interview inquiring about AEs:delusions,hallucinations,paranoia,psychosis,mania,panic,agitation,hostility,aggression,homicidal ideation. If participant had positive response,investigator determined if it met AE criteria.
Time Frame Baseline up to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all participants who took at least 1 dose of randomized study medication, including partial doses, and had a safety measurement.
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description:
Varenicline 0.5 milligram (mg) tablet given orally once daily up to Day 3 followed by varenicline 0.5 mg tablet orally twice daily up to Day 7 and then varenicline 1 mg tablet given orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
Placebo matched to varenicline 0.5 mg tablet orally once daily up to Day 3 followed by placebo matched to varenicline 0.5 mg tablet orally twice daily up to Day 7 and then placebo matched to varenicline 1 mg tablet orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
Overall Number of Participants Analyzed 256 269
Measure Type: Number
Unit of Measure: participants
185 180
6.Other Pre-specified Outcome
Title Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)
Hide Description CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement from baseline is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected
Time Frame Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16, 24, 32, 40, 52
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' is signifying those participants who were evaluated for this measure at the time point for each group respectively.
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description:
Varenicline 0.5 milligram (mg) tablet given orally once daily up to Day 3 followed by varenicline 0.5 mg tablet orally twice daily up to Day 7 and then varenicline 1 mg tablet given orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
Placebo matched to varenicline 0.5 mg tablet orally once daily up to Day 3 followed by placebo matched to varenicline 0.5 mg tablet orally twice daily up to Day 7 and then placebo matched to varenicline 1 mg tablet orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
Overall Number of Participants Analyzed 250 263
Measure Type: Number
Unit of Measure: participants
Week 1: very much improved(n=250,263) 1 2
Week 1: much improved(n=250,263) 12 6
Week 1: minimally improved(n=250,263) 31 21
Week 1: no change(n=250,263) 189 222
Week 1: minimally worse(n=250,263) 16 11
Week 1: much worse(n=250,263) 1 1
Week 2: very much improved(n=244,255) 2 1
Week 2: much improved(n=244,255) 18 12
Week 2: minimally improved(n=244,255) 33 38
Week 2: no change(n=244,255) 159 181
Week 2: minimally worse(n=244,255) 27 21
Week 2: much worse(n=244,255) 5 2
Week 3: very much improved(n=241,248) 10 4
Week 3: much improved(n=241,248) 17 14
Week 3: minimally improved(n=241,248) 42 45
Week 3: no change(n=241,248) 146 165
Week 3: minimally worse(n=241,248) 26 17
Week 3: much worse(n=241,248) 0 3
Week 4: very much improved(n=230,245) 8 6
Week 4: much improved(n=230,245) 18 12
Week 4: minimally improved(n=230,245) 35 51
Week 4: no change(n=230,245) 152 154
Week 4: minimally worse(n=230,245) 15 19
Week 4: much worse(n=230,245) 2 3
Week 5: very much improved(n=227,233) 13 9
Week 5: much improved(n=227,233) 14 11
Week 5: minimally improved(n=227,233) 34 46
Week 5: no change(n=227,233) 146 151
Week 5: minimally worse(n=227,233) 19 14
Week 5: much worse(n=227,233) 1 2
Week 6: very much improved(n=224,226) 11 6
Week 6: much improved(n=224,226) 20 14
Week 6: minimally improved(n=224,226) 39 41
Week 6: no change(n=224,226) 139 148
Week 6: minimally worse(n=224,226) 13 17
Week 6: much worse(n=224,226) 2 0
Week 7: very much improved(n=226,226) 19 9
Week 7: much improved(n=226,226) 23 18
Week 7: minimally improved(n=226,226) 32 34
Week 7: no change(n=226,226) 136 150
Week 7: minimally worse(n=226,226) 14 13
Week 7: much worse(n=226,226) 2 2
Week 8: very much improved(n=221,217) 19 12
Week 8: much improved(n=221,217) 18 15
Week 8: minimally improved(n=221,217) 37 40
Week 8: no change(n=221,217) 131 139
Week 8: minimally worse(n=221,217) 15 10
Week 8: much worse(n=221,217) 0 1
Week 8: very much worse(n=221,217) 1 0
Week 9: very much improved(n=218,214) 19 13
Week 9: much improved(n=218,214) 19 16
Week 9: minimally improved(n=218,214) 36 31
Week 9: no change(n=218,214) 129 141
Week 9: minimally worse(n=218,214) 15 13
Week 10: very much improved(n=212,211) 20 13
Week 10: much improved(n=212,211) 21 18
Week 10: minimally improved(n=212,211) 30 35
Week 10: no change(n=212,211) 124 133
Week 10: minimally worse(n=212,211) 16 11
Week 10: much worse(n=212,211) 1 1
Week 11: very much improved(n=211,205) 23 15
Week 11: much improved(n=211,205) 17 14
Week 11: minimally improved(n=211,205) 38 35
Week 11: no change(n=211,205) 120 129
Week 11: minimally worse(n=211,205) 13 10
Week 11: much worse(n=211,205) 0 2
Week 12: very much improved(n=210,204) 19 17
Week 12: much improved(n=210,204) 19 13
Week 12: minimally improved(n=210,204) 34 39
Week 12: no change(n=210,204) 127 124
Week 12: minimally worse(n=210,204) 11 11
Week 13: very much improved(n=211,200) 18 16
Week 13: much improved(n=211,200) 19 13
Week 13: minimally improved(n=211,200) 34 40
Week 13: no change(n=211,200) 127 121
Week 13: minimally worse(n=211,200) 12 10
Week 13: much worse(n=211,200) 1 0
Week 16: very much improved(n=203,199) 17 15
Week 16: much improved(n=203,199) 27 16
Week 16: minimally improved(n=203,199) 26 33
Week 16: no change(n=203,199) 119 119
Week 16: minimally worse(n=203,199) 14 12
Week 16: much worse(n=203,199) 0 4
Week 24: very much improved(n=196,193) 17 13
Week 24: much improved(n=196,193) 17 18
Week 24: minimally improved(n=196,193) 24 31
Week 24: no change(n=196,193) 127 125
Week 24: minimally worse(n=196,193) 10 6
Week 24: much worse(n=196,193) 1 0
Week 32: very much improved(n=188,188) 15 19
Week 32: much improved(n=188,188) 19 21
Week 32: minimally improved(n=188,188) 27 31
Week 32: no change(n=188,188) 118 113
Week 32: minimally worse(n=188,188) 9 3
Week 32: much worse(n=188,188) 0 1
Week 40: very much improved(n=180,182) 10 17
Week 40: much improved(n=180,182) 23 15
Week 40: minimally improved(n=180,182) 23 32
Week 40: no change(n=180,182) 117 109
Week 40: minimally worse(n=180,182) 6 7
Week 40: much worse(n=180,182) 0 2
Week 40: very much worse(n=180,182) 1 0
Week 52: very much improved(n=178,180) 20 22
Week 52: much improved(n=178,180) 20 13
Week 52: minimally improved(n=178,180) 25 26
Week 52: no change(n=178,180) 110 112
Week 52: minimally worse(n=178,180) 3 7
7.Other Pre-specified Outcome
Title Number of Participants With Clinical Global Impression - Severity (CGI-S) Score
Hide Description CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected
Time Frame Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16, 24, 32, 40, 52
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all participants who took at least 1 dose of randomized study medication, including partial doses, and had a safety measurement. Here, the ‘n’ is signifying those participants who were evaluable for this measure at the specific categories for each arm group.
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description:
Varenicline 0.5 milligram (mg) tablet given orally once daily up to Day 3 followed by varenicline 0.5 mg tablet orally twice daily up to Day 7 and then varenicline 1 mg tablet given orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
Placebo matched to varenicline 0.5 mg tablet orally once daily up to Day 3 followed by placebo matched to varenicline 0.5 mg tablet orally twice daily up to Day 7 and then placebo matched to varenicline 1 mg tablet orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
Overall Number of Participants Analyzed 256 269
Measure Type: Number
Unit of Measure: participants
Baseline:Normal; Week 1:Normal (n=250,263) 105 100
Baseline:Borderline; Week 1:Normal (n=250,263) 7 8
Baseline:Mildly; Week 1:Normal (n=250,263) 4 1
Baseline:Moderately; Week 1:Normal (n=250,263) 1 0
Baseline:Normal; Week 1:Borderline (n=250,263) 3 3
Baseline:Borderline; Week 1:Borderline (n=250,263) 31 42
Baseline:Mildly; Week 1:Borderline (n=250,263) 9 3
Baseline:Moderately; Week 1:Borderline (n=250,263) 2 3
Baseline:Normal; Week 1:Mildly (n=250,263) 0 2
Baseline:Borderline; Week 1:Mildly (n=250,263) 4 1
Baseline:Mildly; Week 1:Mildly (n=250,263) 46 56
Baseline:Moderately; Week 1:Mildly (n=250,263) 6 9
Baseline:Borderline; Week 1:Moderately (n=250,263) 1 2
Baseline:Mildly; Week 1:Moderately (n=250,263) 1 0
Baseline:Moderately; Week 1:Moderately (n=250,263) 28 30
Baseline:Markedly; Week 1:Moderately (n=250,263) 1 0
Baseline:Markedly; Week 1:Markedly (n=250,263) 1 3
Baseline:Normal; Week 2:Normal (n=244,254) 102 96
Baseline:Borderline; Week 2:Normal (n=244,254) 13 12
Baseline:Mildly; Week 2:Normal (n=244,254) 5 0
Baseline: Moderately; Week 2:Normal (n=244,254) 0 1
Baseline:Normal; Week 2:Borderline (n=244,254) 1 5
Baseline:Borderline; Week 2:Borderline (n=244,254) 22 37
Baseline:Mildly; Week 2:Borderline (n=244,254) 10 7
Baseline:Moderately; Week 2:Borderline (n=244,254) 4 4
Baseline:Normal; Week 2:Mildly (n=244,254) 3 2
Baseline:Borderline; Week 2:Mildly (n=244,254) 4 0
Baseline:Mildly; Week 2:Mildly (n=244,254) 40 48
Baseline:Moderately; Week 2:Mildly (n=244,254) 10 12
Baseline:Markedly; Week 2:Mildly (n=244,254) 1 0
Baseline:Normal; Week 2:Moderately (n=244,254) 2 0
Baseline:Borderline; Week 2:Moderately (n=244,254) 1 1
Baseline:Mildly; Week 2:Moderately (n=244,254) 2 2
Baseline:Moderately; Week 2:Moderately (n=244,254) 20 24
Baseline:Markedly; Week 2:Moderately (n=244,254) 0 1
Baseline: Moderately; Week 2:Markedly (n=244,254) 3 0
Baseline:Markedly; Week 2:Markedly (n=244,254) 1 2
Baseline:Normal; Week 3:Normal (n=241,247) 101 95
Baseline:Borderline; Week 3:Normal (n=241,247) 18 16
Baseline:Mildly; Week 3:Normal (n=241,247) 6 4
Baseline:Moderately; Week 3:Normal (n=241,247) 2 0
Baseline:Normal; Week 3:Borderline (n=241,247) 3 2
Baseline:Borderline; Week 3:Borderline (n=241,247) 16 34
Baseline:Mildly; Week 3:Borderline (n=241,247) 8 7
Baseline:Moderately; Week 3:Borderline (n=241,247) 4 2
Baseline:Normal; Week 3:Mildly (n=241,247) 2 0
Baseline:Borderline; Week 3:Mildly (n=241,247) 6 2
Baseline:Mildly; Week 3:Mildly (n=241,247) 42 42
Baseline:Moderately; Week 3:Mildly (n=241,247) 10 17
Baseline:Markedly; Week 3:Mildly (n=241,247) 1 0
Baseline:Normal; Week 3:Moderately (n=241,247) 0 2
Baseline:Mildly; Week 3:Moderately (n=241,247) 2 1
Baseline:Moderately; Week 3:Moderately (n=241,247) 19 20
Baseline:Markedly; Week 3:Moderately (n=241,247) 0 1
Baseline:Moderately; Week 3:Markedly (n=241,247) 0 1
Baseline:Markedly; Week 3:Markedly (n=241,247) 1 1
Baseline:Normal; Week 4:Normal (n=230,244) 101 92
Baseline:Borderline; Week 4:Normal (n=230,244) 17 17
Baseline:Mildly; Week 4:Normal (n=230,244) 7 5
Baseline:Moderately; Week 4:Normal (n=230,244) 4 1
Baseline:Normal; Week 4:Borderline (n=230,244) 2 5
Baseline:Borderline; Week 4:Borderline (n=230,244) 17 27
Baseline:Mildly; Week 4:Borderline (n=230,244) 8 7
Baseline:Moderately; Week 4:Borderline (n=230,244) 1 3
Baseline:Normal; Week 4:Mildly (n=230,244) 0 2
Baseline:Borderline; Week 4:Mildly (n=230,244) 3 2
Baseline:Mildly; Week 4:Mildly (n=230,244) 39 43
Baseline:Moderately; Week 4:Mildly (n=230,244) 11 15
Baseline:Markedly; Week 4:Mildly (n=230,244) 1 1
Baseline:Borderline; Week 4:Moderately (n=230,244) 2 0
Baseline:Mildly; Week 4:Moderately (n=230,244) 2 2
Baseline:Moderately; Week 4:Moderately (n=230,244) 12 2
Baseline:Markedly; Week 4:Moderately (n=230,244) 1 18
Baseline:Borderline; Week 4:Markedly (n=230,244) 1 0
Baseline:Moderately; Week 4:Markedly (n=230,244) 1 0
Baseline:Markedly; Week 4:Markedly (n=230,244) 0 2
Baseline:Normal; Week 5:Normal (n=227,232) 98 88
Baseline:Borderline; Week 5:Normal (n=227,232) 19 16
Baseline:Mildly; Week 5:Normal (n=227,232) 8 6
Baseline:Moderately; Week 5:Normal (n=227,232) 4 4
Baseline:Normal; Week 5:Borderline (n=227,232) 2 1
Baseline:Borderline; Week 5:Borderline (n=227,232) 13 30
Baseline:Mildly; Week 5:Borderline (n=227,232) 8 4
Baseline:Moderately; Week 5:Borderline (n=227,232) 2 3
Baseline:Normal; Week 5:Mildly (n=227,232) 2 1
Baseline:Borderline; Week 5:Mildly (n=227,232) 6 2
Baseline:Mildly; Week 5:Mildly (n=227,232) 36 39
Baseline:Moderately; Week 5:Mildly (n=227,232) 11 15
Baseline:Markedly; Week 5:Mildly (n=227,232) 2 1
Baseline:Normal; Week 5:Moderately (n=227,232) 0 1
Baseline:Borderline; Week 5:Moderately (n=227,232) 1 0
Baseline:Mildly; Week 5:Moderately (n=227,232) 2 4
Baseline:Moderately; Week 5:Moderately (n=227,232) 12 15
Baseline:Markedly; Week 5:Moderately (n=227,232) 0 1
Baseline:Moderately; Week 5:Markedly (n=227,232) 1 1
Baseline:Normal; Week 6:Normal (n=224,225) 96 84
Baseline:Borderline; Week 6:Normal (n=224,225) 22 18
Baseline:Mildly; Week 6:Normal (n=224,225) 10 4
Baseline:Moderately; Week 6:Normal (n=224,225) 3 1
Baseline:Normal; Week 6:Borderline (n=224,225) 3 3
Baseline:Borderline; Week 6:Borderline (n=224,225) 11 24
Baseline:Mildly; Week 6:Borderline (n=224,225) 6 7
Baseline:Moderately; Week 6:Borderline (n=224,225) 5 4
Baseline:Normal; Week 6:Mildly (n=224,225) 2 2
Baseline:Borderline; Week 6:Mildly (n=224,225) 5 2
Baseline:Mildly; Week 6:Mildly (n=224,225) 38 37
Baseline:Moderately; Week 6:Mildly (n=224,225) 8 15
Baseline:Markedly; Week 6:Mildly (n=224,225) 2 1
Baseline:Normal; Week 6:Moderately (n=224,225) 0 3
Baseline:Borderline; Week 6:Moderately (n=224,225) 1 1
Baseline:Mildly; Week 6:Moderately (n=224,225) 1 3
Baseline:Moderately; Week 6:Moderately (n=224,225) 10 14
Baseline:Moderately; Week 6:Markedly (n=224,225) 1 1
Baseline:Markedly; Week 6:Markedly (n=224,225) 0 1
Baseline:Normal; Week 7:Normal (n=226,225) 93 88
Baseline:Borderline; Week 7:Normal (n=226,225) 23 20
Baseline:Mildly; Week 7:Normal (n=226,225) 14 5
Baseline:Moderately; Week 7:Normal (n=226,225) 3 1
Baseline:Normal; Week 7:Borderline (n=226,225) 5 2
Baseline:Borderline; Week 7:Borderline (n=226,225) 13 23
Baseline:Mildly; Week 7:Borderline (n=226,225) 4 6
Baseline:Moderately; Week 7:Borderline (n=226,225) 5 8
Baseline:Markedly; Week 7:Borderline (n=226,225) 1 0
Baseline:Normal; Week 7:Mildly (n=226,225) 2 0
Baseline:Borderline; Week 7:Mildly (n=226,225) 2 2
Baseline:Mildly; Week 7:Mildly (n=226,225) 36 37
Baseline:Moderately; Week 7:Mildly (n=226,225) 10 10
Baseline:Markedly; Week 7:Mildly (n=226,225) 1 1
Baseline:Normal; Week 7:Moderately (n=226,225) 0 1
Baseline:Borderline; Week 7:Moderately (n=226,225) 1 1
Baseline:Mildly; Week 7:Moderately (n=226,225) 2 4
Baseline:Moderately; Week 7:Moderately (n=226,225) 10 14
Baseline:Markedly; Week 7:Moderately (n=226,225) 0 1
Baseline:Moderately; Week 7:Markedly (n=226,225) 1 1
Baseline:Normal; Week 8:Normal (n=221,216) 92 87
Baseline:Borderline; Week 8:Normal (n=221,216) 21 19
Baseline:Mildly; Week 8:Normal (n=221,216) 12 6
Baseline:Moderately; Week 8:Normal (n=221,216) 3 3
Baseline:Normal; Week 8:Borderline (n=221,216) 4 2
Baseline:Borderline; Week 8:Borderline (n=221,216) 14 19
Baseline:Mildly; Week 8:Borderline (n=221,216) 6 7
Baseline:Moderately; Week 8:Borderline (n=221,216) 7 5
Baseline:Markedly; Week 8:Borderline (n=221,216) 2 0
Baseline:Normal; Week 8:Mildly (n=221,216) 2 0
Baseline:Borderline; Week 8:Mildly (n=221,216) 3 2
Baseline:Mildly; Week 8:Mildly (n=221,216) 32 35
Baseline:Moderately; Week 8:Mildly (n=221,216) 9 13
Baseline:Markedly; Week 8:Mildly (n=221,216) 0 1
Baseline:Normal; Week 8:Moderately (n=221,216) 1 0
Baseline:Mildly; Week 8:Moderately (n=221,216) 3 3
Baseline:Moderately; Week 8:Moderately (n=221,216) 9 12
Baseline:Markedly; Week 8:Moderately (n=221,216) 0 1
Baseline:Mildly; Week 8:Markedly (n=221,216) 0 1
Baseline:Moderately; Week 8:Markedly (n=221,216) 1 0
Baseline:Normal; Week 9:Normal (n=218,213) 91 87
Baseline:Borderline; Week 9:Normal (n=218,213) 22 18
Baseline:Mildly; Week 9:Normal (n=218,213) 11 5
Baseline:Moderately; Week 9:Normal (n=218,213) 4 4
Baseline:Normal; Week 9:Borderline (n=218,213) 3 2
Baseline:Borderline; Week 9:Borderline (n=218,213) 13 19
Baseline:Mildly; Week 9:Borderline (n=218,213) 6 3
Baseline:Moderately; Week 9:Borderline (n=218,213) 6 8
Baseline:Markedly; Week 9:Borderline (n=218,213) 2 1
Baseline:Normal; Week 9:Mildly (n=218,213) 3 0
Baseline:Borderline; Week 9:Mildly (n=218,213) 2 4
Baseline:Mildly; Week 9:Mildly (n=218,213) 34 38
Baseline:Moderately; Week 9:Mildly (n=218,213) 10 9
Baseline:Mildly; Week 9:Moderately (n=218,213) 1 0
Baseline:Moderately; Week 9:Moderately (n=218,213) 8 12
Baseline:Markedly; Week 9:Moderately (n=218,213) 0 1
Baseline:Mildly; Week 9:Markedly (n=218,213) 1 1
Baseline:Moderately; Week 9:Markedly (n=218,213) 1 1
Baseline:Normal; Week 10:Normal (n=212,210) 88 85
Baseline:Borderline; Week 10:Normal (n=212,210) 20 21
Baseline:Mildly; Week 10:Normal (n=212,210) 13 5
Baseline:Moderately; Week 10:Normal (n=212,210) 7 5
Baseline:Normal; Week 10:Borderline (n=212,210) 5 1
Baseline:Borderline; Week 10:Borderline (n=212,210 14 18
Baseline:Mildly; Week 10:Borderline (n=212,210) 6 6
Baseline:Moderately; Week 10:Borderline(n=212,210) 4 7
Baseline:Markedly; Week 10:Borderline(n=212,210) 2 1
Baseline:Normal; Week 10:Mildly (n=212,210) 1 1
Baseline:Borderline; Week 10:Mildly (n=212,210) 1 2
Baseline:Mildly; Week 10:Mildly (n=212,210) 29 35
Baseline:Moderately; Week 10:Mildly (n=212,210) 8 11
Baseline:Normal; Week 10:Moderately (n=212,210) 1 0
Baseline:Mildly; Week 10:Moderately (n=212,210) 3 1
Baseline:Moderately; Week 10:Moderately(n=212,210) 9 9
Baseline:Markedly; Week 10:Moderately (n=212,210) 0 1
Baseline:Moderately; Week 10:Markedly (n=212,210) 1 1
Baseline:Normal; Week 11:Normal (n=211,205) 90 81
Baseline:Borderline; Week 11:Normal (n=211,205) 23 22
Baseline:Mildly; Week 11:Normal (n=211,205) 13 6
Baseline:Moderately; Week 11:Normal (n=211,205) 7 5
Baseline:Markedly; Week 11:Normal (n=211,205) 1 0
Baseline:Normal; Week 11:Borderline (n=211,205) 3 2
Baseline:Borderline; Week 11:Borderline(n=211,205) 10 15
Baseline:Mildly; Week 11:Borderline (n=211,205) 6 3
Baseline:Moderately; Week 11:Borderline(n=211,205) 3 6
Baseline:Markedly; Week 11:Borderline (n=211,205) 1 1
Baseline:Normal; Week 11:Mildly (n=211,205) 1 0
Baseline:Borderline; Week 11:Mildly (n=211,205) 2 3
Baseline:Mildly; Week 11:Mildly (n=211,205) 30 34
Baseline:Moderately; Week 11:Mildly (n=211,205) 9 13
Baseline:Normal; Week 11:Moderately (n=211,205) 0 1
Baseline:Mildly; Week 11:Moderately (n=211,205) 3 1
Baseline:Moderately; Week 11:Moderately(n=211,205) 8 10
Baseline:Markedly; Week 11:Moderately (n=211,205) 0 1
Baseline:Mildly; Week 11:Markedly (n=211,205) 0 1
Baseline:Normal; Week 12:Normal (n=210,203) 89 79
Baseline:Borderline; Week 12:Normal (n=210,203) 23 22
Baseline:Mildly; Week 12:Normal (n=210,203) 13 6
Baseline:Moderately; Week 12:Normal (n=210,203) 6 8
Baseline:Markedly; Week 12:Normal (n=210,203) 1 0
Baseline:Normal; Week 12:Borderline (n=210,203) 4 2
Baseline:Borderline; Week 12:Borderline(n=210,203) 12 16
Baseline:Mildly; Week 12:Borderline (n=210,203) 6 4
Baseline:Moderately; Week 12:Borderline(n=210,203) 4 3
Baseline:Markedly; Week 12:Borderline (n=210,203) 1 1
Baseline:Normal; Week 12:Mildly (n=210,203) 0 2
Baseline:Borderline; Week 12:Mildly (n=210,203) 0 1
Baseline:Mildly; Week 12:Mildly (n=210,203) 30 34
Baseline:Moderately; Week 12:Mildly (n=210,203) 9 14
Baseline:Borderline; Week 12:Moderately(n=210,203) 0 1
Baseline:Mildly; Week 12:Moderately (n=210,203) 3 3
Baseline:Moderately; Week 12:Moderately(n=210,203) 8 6
Baseline:Markedly; Week 12:Moderately(n=210,203) 0 1
Baseline:Moderately; Week 12:Markedly(n=210,203) 1 0
Baseline:Normal; Week 13:Normal (n=211,199) 92 78
Baseline:Borderline; Week 13:Normal (n=211,199) 22 21
Baseline:Mildly; Week 13:Normal (n=211,199) 13 5
Baseline:Moderately; Week 13:Normal (n=211,199) 6 9
Baseline:Markedly; Week 13:Normal (n=211,199) 2 0
Baseline:Normal; Week 13:Borderline (n=211,199) 3 3
Baseline:Borderline; Week 13:Borderline(n=211,199) 11 17
Baseline:Mildly; Week 13:Borderline (n=211,199) 7 6
Baseline:Moderately; Week 13:Borderline(n=211,199) 5 4
Baseline:Markedly; Week 13:Borderline(n=211,199) 0 1
Baseline:Borderline; Week 13:Mildly (n=211,199) 0 3
Baseline:Mildly; Week 13:Mildly (n=211,199) 30 32
Baseline:Moderately; Week 13:Mildly (n=211,199) 9 11
Baseline:Mildly; Week 13:Moderately (n=211,199) 3 1
Baseline:Moderately; Week 13:Moderately(n=211,199) 7 7
Baseline:Markedly; Week 13:Moderately(n=211,199) 0 1
Baseline:Moderately; Week 13:Markedly (n=211,199) 1 0
Baseline:Normal; Week 16:Normal (n=203,198) 91 78
Baseline:Borderline; Week 16:Normal (n=203,198) 19 20
Baseline:Mildly; Week 16:Normal (n=203,198) 14 6
Baseline:Moderately; Week 16:Normal (n=203,198) 7 11
Baseline:Markedly; Week 16:Normal (n=203,198) 2 0
Baseline:Normal; Week 16:Borderline (n=203,198) 2 2
Baseline:Borderline; Week 16:Borderline(n=203,198) 11 16
Baseline:Mildly; Week 16:Borderline (n=203,198) 4 5
Baseline:Moderately; Week 16:Borderline(n=203,198) 2 2
Baseline:Markedly; Week 16:Borderline (n=203,198) 0 1
Baseline:Normal; Week 16:Mildly (n=203,198) 1 2
Baseline:Borderline; Week 16:Mildly (n=203,198) 0 3
Baseline:Mildly; Week 16:Mildly (n=203,198) 30 30
Baseline:Moderately; Week 16:Mildly (n=203,198) 11 8
Baseline:Borderline; Week 16:Moderately(n=203,198) 0 2
Baseline:Mildly; Week 16:Moderately (n=203,198) 3 2
Baseline:Moderately; Week 16:Moderately(n=203,198) 4 8
Baseline:Markedly; Week 16:Moderately (n=203,198) 0 1
Baseline:Moderately; Week 16:Markedly (n=203,198) 2 1
Baseline:Normal; Week 24:Normal (n=196,192) 88 78
Baseline:Borderline; Week 24:Normal (n=196,192) 18 19
Baseline:Mildly; Week 24:Normal (n=196,192) 15 6
Baseline:Moderately; Week 24:Normal (n=196,192) 5 8
Baseline:Markedly; Week 24:Normal (n=196,192) 2 0
Baseline:Normal; Week 24:Borderline (n=196,192) 0 3
Baseline:Borderline; Week 24:Borderline(n=196,192) 13 14
Baseline:Mildly; Week 24:Borderline (n=196,192) 4 6
Baseline:Moderately; Week 24:Borderline(n=196,192) 2 2
Baseline:Markedly; Week 24:Borderline (n=196,192) 0 1
Baseline:Normal; Week 24:Mildly (n=196,192) 2 1
Baseline:Borderline; Week 24:Mildly (n=196,192) 0 3
Baseline:Mildly; Week 24:Mildly (n=196,192) 27 31
Baseline:Moderately; Week 24:Mildly (n=196,192) 8 12
Baseline:Mildly; Week 24:Moderately (n=196,192) 4 0
Baseline:Moderately; Week 24:Moderately(n=196,192) 7 7
Baseline:Markedly; Week 24:Moderately (n=196,192) 0 1
Baseline:Moderately; Week 24:Markedly (n=196,192) 1 0
Baseline:Normal; Week 32:Normal (n=188,187) 82 77
Baseline:Borderline; Week 32:Normal (n=188,187) 16 20
Baseline:Mildly; Week 32:Normal (n=188,187) 10 8
Baseline:Moderately; Week 32:Normal (n=188,187) 4 9
Baseline:Markedly; Week 32:Normal (n=188,187) 2 0
Baseline:Normal; Week 32:Borderline (n=188,187) 0 1
Baseline:Borderline; Week 32:Borderline(n=188,187) 12 15
Baseline:Mildly; Week 32:Borderline (n=188,187) 9 7
Baseline:Moderately; Week 32:Borderline(n=188,187) 4 1
Baseline:Markedly; Week 32:Borderline (n=188,187) 0 1
Baseline:Normal; Week 32:Mildly (n=188,187) 2 0
Baseline:Borderline; Week 32:Mildly (n=188,187) 0 1
Baseline:Mildly; Week 32:Mildly (n=188,187) 28 29
Baseline:Moderately; Week 32:Mildly (n=188,187) 8 11
Baseline:Markedly; Week 32:Mildly (n=188,187) 0 1
Baseline:Mildly; Week 32:Moderately (n=188,187) 3 0
Baseline:Moderately; Week 32:Moderately(n=188,187) 7 5
Baseline:Borderline; Week 32:Markedly (n=188,187) 0 1
Baseline:Moderately; Week 32:Markedly (n=188,187) 1 0
Baseline:Normal; Week 40:Normal (n=180,181) 81 71
Baseline:Borderline; Week 40:Normal (n=180,181) 17 20
Baseline:Mildly; Week 40:Normal (n=180,181) 11 7
Baseline:Moderately; Week 40:Normal (n=180,181) 2 7
Baseline:Markedly; Week 40:Normal (n=180,181) 2 0
Baseline:Normal; Week 40:Borderline (n=180,181) 0 2
Baseline:Borderline; Week 40:Borderline(n=180,181) 9 15
Baseline:Mildly; Week 40:Borderline (n=180,181) 8 6
Baseline:Moderately; Week 40:Borderline(n=180,181) 4 2
Baseline:Markedly; Week 40:Borderline (n=180,181) 0 1
Baseline:Normal; Week 40:Mildly (n=180,181) 1 0
Baseline:Borderline; Week 40:Mildly (n=180,181) 2 2
Baseline:Mildly; Week 40:Mildly (n=180,181) 25 28
Baseline:Moderately; Week 40:Mildly (n=180,181) 11 12
Baseline:Markedly; Week 40:Mildly (n=180,181) 0 1
Baseline:Normal; Week 40:Moderately (n=180,181) 0 1
Baseline:Mildly; Week 40:Moderately (n=180,181) 2 1
Baseline:Moderately; Week 40:Moderately(n=180,181) 4 3
Baseline:Moderately; Week 40:Markedly (n=180,181) 1 2
Baseline:Normal; Week 52:Normal (n=178,179) 81 69
Baseline:Borderline; Week 52:Normal (n=178,179) 19 20
Baseline:Mildly; Week 52:Normal (n=178,179) 12 7
Baseline:Moderately; Week 52:Normal (n=178,179) 4 7
Baseline:Markedly; Week 52:Normal (n=178,179) 2 0
Baseline:Normal; Week 52:Borderline (n=178,179) 1 4
Baseline:Borderline; Week 52:Borderline(n=178,179) 8 14
Baseline:Mildly; Week 52:Borderline (n=178,179) 8 8
Baseline:Moderately; Week 52:Borderline(n=178,179) 4 4
Baseline:Markedly; Week 52:Borderline (n=178,179) 0 1
Baseline:Normal; Week 52:Mildly (n=178,179) 1 0
Baseline:Borderline; Week 52:Mildly (n=178,179) 0 2
Baseline:Mildly; Week 52:Mildly (n=178,179) 24 26
Baseline:Moderately; Week 52:Mildly (n=178,179) 8 11
Baseline:Mildly; Week 52:Moderately (n=178,179) 1 1
Baseline:Moderately; Week 52:Moderately(n=178,179) 4 4
Baseline:Markedly; Week 52:Moderately (n=178,179) 0 1
Baseline:Moderately; Week 52:Markedly (n=178,179) 1 0
8.Other Pre-specified Outcome
Title Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score
Hide Description Measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Change: mean score at observation minus mean score at baseline.
Time Frame Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all participants who took at least 1 dose of randomized study medication, including partial doses, and had a safety measurement. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description:
Varenicline 0.5 milligram (mg) tablet given orally once daily up to Day 3 followed by varenicline 0.5 mg tablet orally twice daily up to Day 7 and then varenicline 1 mg tablet given orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
Placebo matched to varenicline 0.5 mg tablet orally once daily up to Day 3 followed by placebo matched to varenicline 0.5 mg tablet orally twice daily up to Day 7 and then placebo matched to varenicline 1 mg tablet orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
Overall Number of Participants Analyzed 256 269
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline(n=256,269) 7.6  (7.38) 7.9  (7.51)
Change at Week 1(n=250,265) -1.2  (3.95) -0.6  (4.17)
Change at Week 2(n= 245, 255) -1.0  (6.06) -1.1  (5.33)
Change at Week 3(n= 241, 249) -1.9  (5.19) -1.8  (4.96)
Change at Week 4(n= 230, 246) -2.2  (5.62) -1.5  (5.96)
Change at Week 5(n=228, 235) -2.1  (6.01) -2.3  (6.09)
Change at Week 6(n=224, 227) -2.2  (6.15) -2.3  (5.84)
Change at Week 7(n=226, 227) -2.3  (6.57) -2.4  (5.94)
Change at Week 8(n=221, 218) -2.7  (6.51) -2.6  (6.02)
Change at Week 9(n=218, 216) -2.9  (6.11) -2.5  (6.55)
Change at Week 10(n=214, 212) -2.9  (6.21) -2.8  (6.15)
Change at Week 11(n= 211, 206) -3.2  (6.30) -2.9  (6.13)
Change at Week 12(n= 210, 205) -3.4  (6.20) -3.2  (6.34)
Change at Week 13(n= 211, 201) -3.0  (6.39) -3.6  (5.88)
Change at Week 16(n= 202, 197) -3.1  (6.36) -3.2  (6.61)
9.Other Pre-specified Outcome
Title Change From Baseline in Hamilton Anxiety Scale (HAM-A) - Total Score
Hide Description HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); possible range 0 to 56. Lower score indicates less affected. Change: mean score at observation minus mean score at baseline.
Time Frame Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all participants who took at least 1 dose of randomized study medication, including partial doses, and had a safety measurement. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description:
Varenicline 0.5 milligram (mg) tablet given orally once daily up to Day 3 followed by varenicline 0.5 mg tablet orally twice daily up to Day 7 and then varenicline 1 mg tablet given orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
Placebo matched to varenicline 0.5 mg tablet orally once daily up to Day 3 followed by placebo matched to varenicline 0.5 mg tablet orally twice daily up to Day 7 and then placebo matched to varenicline 1 mg tablet orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
Overall Number of Participants Analyzed 256 269
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline(n=256,269) 6.1  (5.23) 6.4  (5.17)
Change at Week 1(n=250,265) -0.5  (2.54) -0.7  (3.15)
Change at Week 2(n= 245, 255) -0.7  (3.98) -0.5  (3.79)
Change at Week 3(n= 241, 249) -1.3  (3.41) -1.2  (3.68)
Change at Week 4(n= 230, 246) -1.6  (3.72) -1.2  (3.87)
Change at Week 5(n=228, 235) -1.6  (4.05) -1.6  (4.00)
Change at Week 6(n=224, 227) -1.7  (4.03) -1.6  (4.00)
Change at Week 7(n=226, 227) -2.0  (4.40) -1.8  (4.32)
Change at Week 8(n=221, 218) -1.9  (4.65) -1.9  (4.10)
Change at Week 9(n=218, 216) -2.0  (4.40) -1.9  (3.94)
Change at Week 10(n=214, 212) -2.2  (4.24) -2.0  (4.12)
Change at Week 11(n= 211, 206) -2.3  (4.48) -2.1  (4.31)
Change at Week 12(n= 210, 205) -2.3  (4.27) -2.4  (4.47)
Change at Week 13(n= 211, 201) -2.4  (4.49) -2.7  (4.34)
Change at Week 16(n= 202, 197) -2.7  (4.67) -2.5  (4.28)
10.Other Pre-specified Outcome
Title Change From Baseline in Barratt Impulsiveness Scale (BIS-11) - Total Score
Hide Description The BIS-11 is a self-administered 30 items questionnaire to assess measure of impulsivity. Items are scored on a 4-point scale ranging from 1 (rarely/never) to 4 (almost always/always). Total score range from 30 to 120. Barratt suggested that a total score of greater than or equal to 75 could indicate an impulse-control disorder, whereas a total score in the range of 70 to 75 could indicate pathological impulsivity.
Time Frame Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all participants who took at least 1 dose of randomized study medication, including partial doses, and had a safety measurement. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description:
Varenicline 0.5 milligram (mg) tablet given orally once daily up to Day 3 followed by varenicline 0.5 mg tablet orally twice daily up to Day 7 and then varenicline 1 mg tablet given orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
Placebo matched to varenicline 0.5 mg tablet orally once daily up to Day 3 followed by placebo matched to varenicline 0.5 mg tablet orally twice daily up to Day 7 and then placebo matched to varenicline 1 mg tablet orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
Overall Number of Participants Analyzed 256 269
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline(n=256,269) 65.1  (6.42) 64.2  (7.30)
Change at Week 1(n=250,265) -0.5  (4.36) -0.8  (4.26)
Change at Week 2(n= 244, 255) -0.8  (4.73) -1.1  (4.83)
Change at Week 3(n= 241, 249) -1.0  (4.75) -1.3  (4.81)
Change at Week 4(n= 230, 246) -1.0  (5.19) -1.2  (4.95)
Change at Week 5(n=228, 234) -1.1  (5.27) -1.1  (5.39)
Change at Week 6(n=224, 226) -1.4  (5.28) -1.2  (5.43)
Change at Week 7(n=226, 227) -1.6  (5.62) -1.3  (6.08)
Change at Week 8(n=219, 216) -1.3  (5.81) -1.2  (6.54)
Change at Week 9(n=218, 215) -1.5  (6.25) -1.4  (6.24)
Change at Week 10(n=214, 211) -1.5  (6.13) -1.7  (6.94)
Change at Week 11(n= 211, 205) -1.6  (6.24) -1.5  (6.78)
Change at Week 12(n= 210, 204) -1.0  (6.55) -1.4  (7.31)
Change at Week 13(n= 211, 201) -1.4  (6.52) -1.1  (7.00)
Change at Week 16(n= 202, 196) -1.4  (6.25) -1.3  (6.85)
11.Other Pre-specified Outcome
Title Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
Hide Description C-SSRS assessed if participant experienced following: completed suicide (1), suicide attempt (2)(response of “Yes” on “actual attempt”), preparatory acts toward imminent suicidal behavior (3)(“Yes” on “preparatory acts or behavior”), suicidal ideation (4)(“Yes” on “wish to be dead”, “non-specific active suicidal thoughts”, “active suicidal ideation with methods without intent to act or some intent to act, without or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (7)(“Yes” on “Has participant engaged in non-suicidal self-injurious behavior”).
Time Frame Baseline, Week 1 up to 30 days after Week 12 (treatment-emergent [TE]), thereafter up to Week 52 (follow-up [FU])
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all participants who took at least 1 dose of randomized study medication, including partial doses, and had a safety measurement.
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description:
Varenicline 0.5 milligram (mg) tablet given orally once daily up to Day 3 followed by varenicline 0.5 mg tablet orally twice daily up to Day 7 and then varenicline 1 mg tablet given orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
Placebo matched to varenicline 0.5 mg tablet orally once daily up to Day 3 followed by placebo matched to varenicline 0.5 mg tablet orally twice daily up to Day 7 and then placebo matched to varenicline 1 mg tablet orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
Overall Number of Participants Analyzed 256 269
Measure Type: Number
Unit of Measure: participants
Baseline,Suicidal Behavior or/and Ideation 6 1
Baseline,4 6 1
Baseline,4: wish to be dead 6 1
TE,Suicidal Behavior or/and Ideation 15 20
TE,2 0 1
TE,4 15 19
TE,4: wish to be dead 15 18
TE,4: non-specific active suicidal thoughts 4 7
TE,4: with any methods,without intent to act 2 5
TE,4: with some intent,without specific plan. 0 3
TE,4: with specific plan and intent 0 1
FU,Suicidal Behavior or/and Ideation 13 12
FU,1 1 0
FU,4 12 12
FU,4: wish to be dead 11 12
FU,4: non-specific active suicidal thoughts 5 3
FU,4: with any methods,without intent to act 2 2
FU,4: with some intent,without specific plan 1 1
FU,7 1 1
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description Varenicline 0.5 milligram (mg) tablet given orally once daily up to Day 3 followed by varenicline 0.5 mg tablet orally twice daily up to Day 7 and then varenicline 1 mg tablet given orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment. Placebo matched to varenicline 0.5 mg tablet orally once daily up to Day 3 followed by placebo matched to varenicline 0.5 mg tablet orally twice daily up to Day 7 and then placebo matched to varenicline 1 mg tablet orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
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   7/256 (2.73%)   7/269 (2.60%) 
Cardiac disorders     
Palpitations * 1  1/256 (0.39%)  0/269 (0.00%) 
Gastrointestinal disorders     
Acute abdomen * 1  1/256 (0.39%)  0/269 (0.00%) 
General disorders     
Chest pain * 1  0/256 (0.00%)  1/269 (0.37%) 
Device dislocation * 1  0/256 (0.00%)  1/269 (0.37%) 
Hepatobiliary disorders     
Autoimmune hepatitis * 1  1/256 (0.39%)  0/269 (0.00%) 
Infections and infestations     
Bronchitis * 1  0/256 (0.00%)  1/269 (0.37%) 
Device related infection * 1  0/256 (0.00%)  1/269 (0.37%) 
Injury, poisoning and procedural complications     
Fall * 1  0/256 (0.00%)  1/269 (0.37%) 
Fractured coccyx * 1  0/256 (0.00%)  1/269 (0.37%) 
Musculoskeletal and connective tissue disorders     
Intervertebral disc protrusion * 1  1/256 (0.39%)  0/269 (0.00%) 
Ligament laxity * 1  1/256 (0.39%)  0/269 (0.00%) 
Psychiatric disorders     
Agitation * 1  0/256 (0.00%)  1/269 (0.37%) 
Depression * 1  0/256 (0.00%)  1/269 (0.37%) 
Depression suicidal * 1  1/256 (0.39%)  1/269 (0.37%) 
Intentional sefl-injury * 1  1/256 (0.39%)  1/269 (0.37%) 
Psychotic disorder * 1  1/256 (0.39%)  0/269 (0.00%) 
Renal and urinary disorders     
Claculus ureteric * 1  1/256 (0.39%)  0/269 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease * 1  0/256 (0.00%)  1/269 (0.37%) 
Vascular disorders     
Haemodynamic instability * 1  1/256 (0.39%)  0/269 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 15.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Varenicline Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   158/256 (61.72%)   126/269 (46.84%) 
Gastrointestinal disorders     
Constipation * 1  15/256 (5.86%)  9/269 (3.35%) 
Diarrhoea * 1  16/256 (6.25%)  12/269 (4.46%) 
Dry mouth * 1  17/256 (6.64%)  14/269 (5.20%) 
Nausea * 1  69/256 (26.95%)  28/269 (10.41%) 
Vomiting * 1  13/256 (5.08%)  9/269 (3.35%) 
General disorders     
Irritability * 1  28/256 (10.94%)  22/269 (8.18%) 
Infections and infestations     
Nasopharyngitis * 1  14/256 (5.47%)  13/269 (4.83%) 
Upper respiratory tract infection * 1  15/256 (5.86%)  13/269 (4.83%) 
Investigations     
Weight increased * 1  14/256 (5.47%)  5/269 (1.86%) 
Nervous system disorders     
Headache * 1  43/256 (16.80%)  30/269 (11.15%) 
Psychiatric disorders     
Abnormal dreams * 1  29/256 (11.33%)  22/269 (8.18%) 
Agitation * 1  17/256 (6.64%)  10/269 (3.72%) 
Anxiety * 1  18/256 (7.03%)  25/269 (9.29%) 
Depression * 1  17/256 (6.64%)  13/269 (4.83%) 
Insomnia * 1  28/256 (10.94%)  13/269 (4.83%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 15.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
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Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01078298     History of Changes
Other Study ID Numbers: A3051122
First Submitted: February 26, 2010
First Posted: March 2, 2010
Results First Submitted: January 17, 2013
Results First Posted: April 16, 2013
Last Update Posted: April 16, 2013