Trial Outcomes & Findings for Smoking Cessation Study for Patients With Schizophrenia or Schizoaffective Disorder (NCT NCT00644969)
NCT ID: NCT00644969
Last Updated: 2011-04-15
Results Overview
AEs are any untoward medical occurrence in a clinical investigation participant administered a product or medical device. The event does not need to be causally related to the study treatment or usage. SAEs include any untoward medical occurrence that results in death, are life threatening, requires hospitalization or prolongation of hospitalization, results in disability or incapacity or are a congenital anomaly or birth defect in the offspring of a study participant. Lack of efficacy was to be reported as an AE when it was associated with an SAE.
COMPLETED
PHASE3
128 participants
Baseline up to 30 days after last dose of study treatment or up to Week 16
2011-04-15
Participant Flow
Double-blind treatment phase Week 1 to Week 12. Treatment discontinued at Week 12 and participants continued in Post treatment phase (non-treatment follow up) up to Week 24. Participants could discontinue treatment at any time during treatment phase and remain on study through the non-treatment follow up period.
Participant milestones
| Measure |
Varenicline
Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
|
Placebo
Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
|
|---|---|---|
|
Treatment Phase
STARTED
|
85
|
43
|
|
Treatment Phase
COMPLETED
|
71
|
40
|
|
Treatment Phase
NOT COMPLETED
|
14
|
3
|
|
Post Treatment Phase
STARTED
|
71
|
40
|
|
Post Treatment Phase
COMPLETED
|
61
|
37
|
|
Post Treatment Phase
NOT COMPLETED
|
10
|
3
|
Reasons for withdrawal
| Measure |
Varenicline
Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
|
Placebo
Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
|
|---|---|---|
|
Treatment Phase
Randomized, not treated
|
1
|
0
|
|
Treatment Phase
Adverse Event
|
3
|
0
|
|
Treatment Phase
Withdrawal by Subject
|
4
|
0
|
|
Treatment Phase
Lost to Follow-up
|
2
|
2
|
|
Treatment Phase
Other
|
4
|
1
|
|
Post Treatment Phase
Death
|
1
|
0
|
|
Post Treatment Phase
Withdrawal by Subject
|
4
|
2
|
|
Post Treatment Phase
Lost to Follow-up
|
4
|
1
|
|
Post Treatment Phase
Other
|
1
|
0
|
Baseline Characteristics
Smoking Cessation Study for Patients With Schizophrenia or Schizoaffective Disorder
Baseline characteristics by cohort
| Measure |
Varenicline
n=85 Participants
Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
|
Placebo
n=43 Participants
Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
|
Total
n=128 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18 to 34 years
|
33 participants
n=5 Participants
|
11 participants
n=7 Participants
|
44 participants
n=5 Participants
|
|
Age, Customized
35 to 44 years
|
10 participants
n=5 Participants
|
9 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Age, Customized
45 to 64 years
|
42 participants
n=5 Participants
|
23 participants
n=7 Participants
|
65 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
65 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Number of participants with suicidal behavior and / or ideation on Columbia Suicide Severity Rating
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 30 days after last dose of study treatment or up to Week 16Population: Safety analysis set: all participants who took at least 1 dose of randomized study medication, including partial doses and had a safety measurement. Safety assessed Baseline through Week 12 (treatment phase) plus a 30 day lag period after last dose of study treatment).
AEs are any untoward medical occurrence in a clinical investigation participant administered a product or medical device. The event does not need to be causally related to the study treatment or usage. SAEs include any untoward medical occurrence that results in death, are life threatening, requires hospitalization or prolongation of hospitalization, results in disability or incapacity or are a congenital anomaly or birth defect in the offspring of a study participant. Lack of efficacy was to be reported as an AE when it was associated with an SAE.
Outcome measures
| Measure |
Varenicline
n=84 Participants
Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
|
Placebo
n=43 Participants
Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Serious Adverse Events
|
5 participants
|
4 participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Adverse Events
|
70 participants
|
35 participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 24Population: Safety analysis set; Safety assessed Baseline through Week 12 (treatment phase) plus a 30 day lag period after last dose of study treatment). Neuropsychiatric events assessed through Week 24.
Psychiatric Adverse Event symptoms included, but were not restricted to, depression, anxiety, hostility, perceptual / thinking disturbance, suicidal ideation, or suicidal behavior based on clinical judgment and use of the Positive and Negative Syndrome Scale and Columbia Classification Algorithm of Suicide assessments.
Outcome measures
| Measure |
Varenicline
n=84 Participants
Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
|
Placebo
n=43 Participants
Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
|
|---|---|---|
|
Number of Participants With Psychiatric Adverse Events
Abnormal dreams
|
6 participants
|
4 participants
|
|
Number of Participants With Psychiatric Adverse Events
Aggression
|
0 participants
|
1 participants
|
|
Number of Participants With Psychiatric Adverse Events
Agitation
|
0 participants
|
1 participants
|
|
Number of Participants With Psychiatric Adverse Events
Anxiety
|
4 participants
|
4 participants
|
|
Number of Participants With Psychiatric Adverse Events
Depressed mood
|
2 participants
|
1 participants
|
|
Number of Participants With Psychiatric Adverse Events
Depression
|
4 participants
|
3 participants
|
|
Number of Participants With Psychiatric Adverse Events
Hallucination auditory
|
4 participants
|
1 participants
|
|
Number of Participants With Psychiatric Adverse Events
Hallucination visual
|
1 participants
|
0 participants
|
|
Number of Participants With Psychiatric Adverse Events
Initial insomnia
|
1 participants
|
0 participants
|
|
Number of Participants With Psychiatric Adverse Events
Insomnia
|
8 participants
|
2 participants
|
|
Number of Participants With Psychiatric Adverse Events
Nervousness
|
1 participants
|
0 participants
|
|
Number of Participants With Psychiatric Adverse Events
Nightmare
|
1 participants
|
0 participants
|
|
Number of Participants With Psychiatric Adverse Events
Panic reaction
|
1 participants
|
0 participants
|
|
Number of Participants With Psychiatric Adverse Events
Paranoia
|
2 participants
|
0 participants
|
|
Number of Participants With Psychiatric Adverse Events
Psychiatric symptom
|
1 participants
|
0 participants
|
|
Number of Participants With Psychiatric Adverse Events
Restlessness
|
1 participants
|
0 participants
|
|
Number of Participants With Psychiatric Adverse Events
Sleep disorder
|
1 participants
|
1 participants
|
|
Number of Participants With Psychiatric Adverse Events
Suicidal ideation
|
5 participants
|
3 participants
|
|
Number of Participants With Psychiatric Adverse Events
Suicide attempt
|
1 participants
|
0 participants
|
|
Number of Participants With Psychiatric Adverse Events
Tension
|
1 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Baseline to Week 12Population: Safety analysis set; (n)=number of participants with analyzable data at observation for varenicline and placebo, respectively.
PANSS includes 30 items rated on a 7-point scale (1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme) organized as 7 positive symptom subscale items, 7 negative symptom subscale items and 16 general psychopathology items. Total scores range from 30 to 210 with higher scores indicating more extreme symptoms.
Outcome measures
| Measure |
Varenicline
n=84 Participants
Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
|
Placebo
n=43 Participants
Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
|
|---|---|---|
|
Change From Baseline to Week 12 in Positive and Negative Syndrome Scale (PANSS): Total Score
Baseline mean
|
55.88 scores on a scale
Standard Deviation 9.5
|
54.47 scores on a scale
Standard Deviation 10.67
|
|
Change From Baseline to Week 12 in Positive and Negative Syndrome Scale (PANSS): Total Score
Mean change at Week 12 (n=68, 39)
|
-5.19 scores on a scale
Standard Deviation 8.99
|
-3.46 scores on a scale
Standard Deviation 7.52
|
PRIMARY outcome
Timeframe: Baseline to Week 24Population: Safety analysis set; N=number of participants with analyzable data at observation.
PANSS includes 30 items rated on a 7-point scale (1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme) organized as 7 positive symptom subscale items, 7 negative symptom subscale items and 16 general psychopathology items. Total scores range from 30 to 210 with higher scores indicating more extreme symptoms.
Outcome measures
| Measure |
Varenicline
n=61 Participants
Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
|
Placebo
n=37 Participants
Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
|
|---|---|---|
|
Change From Baseline to Week 24 in Positive and Negative Syndrome Scale (PANSS): Total Score
|
-4.77 scores on a scale
Standard Deviation 10.63
|
-3.27 scores on a scale
Standard Deviation 7.98
|
PRIMARY outcome
Timeframe: Baseline to Week 12Population: Safety analysis set; (n)=number of participants with analyzable data at observation for varenicline and placebo, respectively.
PANSS includes 30 items rated on a 7-point scale (1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme) organized as 7 positive symptom subscale items, 7 negative symptom subscale items and 16 general psychopathology items. Positive symptoms (productive symptoms) associated with schizophrenia (delusions, conceptual disorganization, and hallucinatory behavior) are rated on a scale from 1 (absent) to 7 (extreme); total positive subscale scores range from 7 to 49 with higher scores indicating more extreme symptoms.
Outcome measures
| Measure |
Varenicline
n=84 Participants
Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
|
Placebo
n=43 Participants
Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
|
|---|---|---|
|
Change From Baseline to Week 12 in Positive and Negative Syndrome Scale (PANSS): Positive Symptoms Score
Baseline mean
|
13.43 scores on a scale
Standard Deviation 3.23
|
13.53 scores on a scale
Standard Deviation 4.15
|
|
Change From Baseline to Week 12 in Positive and Negative Syndrome Scale (PANSS): Positive Symptoms Score
Mean change at Week 12 (n=68, 39)
|
-1.87 scores on a scale
Standard Deviation 3.34
|
-1.33 scores on a scale
Standard Deviation 2.83
|
PRIMARY outcome
Timeframe: Baseline to Week 24Population: Safety analysis set; N=number of participants with analyzable data at observation.
PANSS includes 30 items rated on a 7-point scale (1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme) organized as 7 positive symptom subscale items, 7 negative symptom subscale items and 16 general psychopathology items. Positive symptoms (productive symptoms) associated with schizophrenia (delusions, conceptual disorganization, and hallucinatory behavior) are rated on a scale from 1 (absent) to 7 (extreme); total positive subscale scores range from 7 to 49 with higher scores indicating more extreme symptoms.
Outcome measures
| Measure |
Varenicline
n=61 Participants
Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
|
Placebo
n=37 Participants
Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
|
|---|---|---|
|
Change From Baseline to Week 24 in Positive and Negative Syndrome Scale (PANSS): Positive Symptoms Score
|
-1.49 scores on a scale
Standard Deviation 3.8
|
-1.68 scores on a scale
Standard Deviation 2.82
|
PRIMARY outcome
Timeframe: Baseline to Week 12Population: Safety analysis set; (n)=number of participants with analyzable data at observation for varenicline and placebo, respectively.
PANSS includes 30 items rated on a 7-point scale (1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme) organized as 7 positive symptom subscale items, 7 negative symptom subscale items and 16 general psychopathology items. Negative symptoms (deficit features) associated with schizophrenia (blunted affect, emotional withdrawal, poor rapport, and passive / apathetic social withdrawal) are rated on a scale from 1 (absent) to 7 (extreme); total negative subscale scores range from 7 to 49 with higher scores indicating more extreme symptoms.
Outcome measures
| Measure |
Varenicline
n=84 Participants
Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
|
Placebo
n=43 Participants
Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
|
|---|---|---|
|
Change From Baseline to Week 12 in Positive and Negative Syndrome Scale (PANSS): Negative Symptoms Score
Baseline mean
|
14.75 scores on a scale
Standard Deviation 4.12
|
14.79 scores on a scale
Standard Deviation 4.95
|
|
Change From Baseline to Week 12 in Positive and Negative Syndrome Scale (PANSS): Negative Symptoms Score
Mean change at Week 12 (n=68, 39)
|
-1 scores on a scale
Standard Deviation 3.37
|
-1.33 scores on a scale
Standard Deviation 2.97
|
PRIMARY outcome
Timeframe: Baseline to Week 24Population: Safety analysis set; N=number of participants with analyzable data at observation.
PANSS includes 30 items rated on a 7-point scale (1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme) organized as 7 positive symptom subscale items, 7 negative symptom subscale items and 16 general psychopathology items. Negative symptoms (deficit features) associated with schizophrenia (blunted affect, emotional withdrawal, poor rapport, and passive / apathetic social withdrawal) are rated on a scale from 1 (absent) to 7 (extreme); total negative subscale scores range from 7 to 49 with higher scores indicating more extreme symptoms.
Outcome measures
| Measure |
Varenicline
n=61 Participants
Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
|
Placebo
n=37 Participants
Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
|
|---|---|---|
|
Change From Baseline to Week 24 in Positive and Negative Syndrome Scale (PANSS): Negative Symptoms Score
|
-1.43 scores on a scale
Standard Deviation 3.68
|
-0.68 scores on a scale
Standard Deviation 3.76
|
PRIMARY outcome
Timeframe: Baseline to Week 12Population: Safety analysis set; (n)=number of participants with analyzable data at observation for varenicline and placebo, respectively.
10-item rating scale to assess the severity of extrapyramidal symptoms rated on a 5-point scale 0 (normal) to 4 (highest severity). Items measured are gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, leg pendulousness, head dropping, glabella tap, tremor, and salivation. Global score calculated by summing individual item scores and dividing by the total number of items; range is 0 to 40 with higher scores indicating greater severity.
Outcome measures
| Measure |
Varenicline
n=84 Participants
Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
|
Placebo
n=43 Participants
Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
|
|---|---|---|
|
Change From Baseline to Week 12 in Simpson Angus Rating Scale (SARS)
Baseline mean
|
1.452 scores on a scale
Standard Deviation 2.061
|
1.139 scores on a scale
Standard Deviation 1.846
|
|
Change From Baseline to Week 12 in Simpson Angus Rating Scale (SARS)
Mean change at Week 12 (n=68, 39)
|
-0.42 scores on a scale
Standard Deviation 1.341
|
0.102 scores on a scale
Standard Deviation 1.984
|
PRIMARY outcome
Timeframe: Baseline to Week 24Population: Safety analysis set; N=number of participants with analyzable data at observation.
10-item rating scale to assess the severity of extrapyramidal symptoms rated on a 5-point scale 0 (normal) to 4 (highest severity). Items measured are gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, leg pendulousness, head dropping, glabella tap, tremor, and salivation. Global score calculated by summing individual item scores and dividing by the total number of items; range is 0 to 40 with higher scores indicating greater severity.
Outcome measures
| Measure |
Varenicline
n=61 Participants
Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
|
Placebo
n=37 Participants
Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
|
|---|---|---|
|
Change From Baseline to Week 24 in Simpson Angus Rating Scale (SARS)
|
-0.37 scores on a scale
Standard Deviation 1.253
|
-0.29 scores on a scale
Standard Deviation 1.221
|
PRIMARY outcome
Timeframe: Week 1 to Week 12 (Treatment phase)Population: Safety analysis set; N=number of participants assessed for suicidal behavior and / or ideation. "Yes" response includes participants with continued or new suicidal behavior and / or ideation. Treatment phase includes a 7 day lag after last dose of study treatment.
C-SSRS is a clinician rated assessment of suicidal behavior and / or intent categorized as: Suicidal behavior=a "yes" response to any of 5 suicidal behavior questions (preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide); Suicidal ideation=a "yes" response to any one of 5 suicidal ideation questions which includes wish to be dead, and 4 different categories of active suicidal ideation (thought, thought with method, thought with intent, thought with plan and intent).
Outcome measures
| Measure |
Varenicline
n=82 Participants
Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
|
Placebo
n=43 Participants
Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
|
|---|---|---|
|
Number of Participants With Suicidal Behavior and / or Ideation ("Yes" Response) on the Columbia Suicide Severity Rating Scale (C-SSRS) During the Treatment Phase
|
9 participants
|
4 participants
|
PRIMARY outcome
Timeframe: Week 13 to Week 24 (Post treatment phase)Population: Safety analysis set; N=number of participants assessed for suicidal behavior and / or ideation. "Yes" response includes participants with new suicidal behavior and / or ideation.
C-SSRS is a clinician rated assessment of suicidal behavior and / or intent categorized as: Suicidal behavior=a "yes" response to any of 5 suicidal behavior questions (preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide); Suicidal ideation=a "yes" response to any one of 5 suicidal ideation questions which includes wish to be dead, and 4 different categories of active suicidal ideation (thought, thought with method, thought with intent, thought with plan and intent).
Outcome measures
| Measure |
Varenicline
n=70 Participants
Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
|
Placebo
n=39 Participants
Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
|
|---|---|---|
|
Number of Participants With Suicidal Behavior or Suicical Ideation ("Yes" Response ) on the Columbia Suicide-Severity Rating Scale (C-SSRS) During the Post Treatment Phase
|
6 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Baseline (Bsl) to Week 12Population: Safety analysis set; N=number of participants with evaluable data at observation.
CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1=normal, not ill at all, 2=borderline mentally ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, 7=among the most extremely ill patients. Higher scores reflect higher severity of current illness states.
Outcome measures
| Measure |
Varenicline
n=68 Participants
Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
|
Placebo
n=39 Participants
Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
|
|---|---|---|
|
Number of Participants With Shift From Baseline to Week 12 in Clinical Global Impressions Scale-Severity (CGI-S) Score
Mildly ill Bsl to Borderline ill Week 12
|
1 participants
|
0 participants
|
|
Number of Participants With Shift From Baseline to Week 12 in Clinical Global Impressions Scale-Severity (CGI-S) Score
Mildly ill Bsl to Moderately ill Week 12
|
1 participants
|
1 participants
|
|
Number of Participants With Shift From Baseline to Week 12 in Clinical Global Impressions Scale-Severity (CGI-S) Score
Moderately ill Bsl to Borderline ill Week 12
|
1 participants
|
0 participants
|
|
Number of Participants With Shift From Baseline to Week 12 in Clinical Global Impressions Scale-Severity (CGI-S) Score
Moderately ill Bsl to Mildly ill Week 12
|
4 participants
|
1 participants
|
|
Number of Participants With Shift From Baseline to Week 12 in Clinical Global Impressions Scale-Severity (CGI-S) Score
Markedly ill Bsl to Moderately ill Week 12
|
1 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Baseline to Week 24Population: Safety analysis set; N=number of participants with evaluable data at observation.
CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1=normal, not ill at all, 2=borderline mentally ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, 7=among the most extremely ill patients. Higher scores reflect higher severity of current illness states.
Outcome measures
| Measure |
Varenicline
n=61 Participants
Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
|
Placebo
n=37 Participants
Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
|
|---|---|---|
|
Number of Participants With Shift From Baseline to Week 24 in Clinical Global Impressions Scale-Severity (CGI-S) Score
Mildly ill Bsl to Borderline ill Week 24
|
1 participants
|
0 participants
|
|
Number of Participants With Shift From Baseline to Week 24 in Clinical Global Impressions Scale-Severity (CGI-S) Score
Mildly ill Bsl to Moderately ill Week 24
|
1 participants
|
1 participants
|
|
Number of Participants With Shift From Baseline to Week 24 in Clinical Global Impressions Scale-Severity (CGI-S) Score
Mildly ill Bsl to Markedly ill Week 24
|
1 participants
|
0 participants
|
|
Number of Participants With Shift From Baseline to Week 24 in Clinical Global Impressions Scale-Severity (CGI-S) Score
Moderately ill Bsl to Borderline ill Week 24
|
1 participants
|
0 participants
|
|
Number of Participants With Shift From Baseline to Week 24 in Clinical Global Impressions Scale-Severity (CGI-S) Score
Moderately ill Bsl to Mildly ill Week 24
|
5 participants
|
1 participants
|
|
Number of Participants With Shift From Baseline to Week 24 in Clinical Global Impressions Scale-Severity (CGI-S) Score
Markedly ill Bsl to Moderately ill Week 24
|
1 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Baseline, Week 1Population: Safety analysis set; N=number of participants with analyzable data at observation.
CGI-I: 7-point clinician rated scale ranging from 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, to 7=very much worse. Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Scores above 4 reflect worsening of illness state as compared to baseline.
Outcome measures
| Measure |
Varenicline
n=79 Participants
Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
|
Placebo
n=43 Participants
Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
|
|---|---|---|
|
Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 1
Very much improved
|
0 participants
|
0 participants
|
|
Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 1
Much improved
|
3 participants
|
0 participants
|
|
Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 1
Minimally improved
|
4 participants
|
3 participants
|
|
Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 1
No change
|
67 participants
|
37 participants
|
|
Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 1
Minimally worse
|
5 participants
|
3 participants
|
|
Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 1
Much worse
|
0 participants
|
0 participants
|
|
Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 1
Very much worse
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: Safety analysis set; N=number of participants with analyzable data at observation.
CGI-I: 7-point clinician rated scale ranging from 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, to 7=very much worse. Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Scores above 4 reflect worsening of illness state as compared to baseline.
Outcome measures
| Measure |
Varenicline
n=68 Participants
Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
|
Placebo
n=39 Participants
Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
|
|---|---|---|
|
Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 12
Very much improved
|
1 participants
|
0 participants
|
|
Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 12
Much improved
|
1 participants
|
0 participants
|
|
Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 12
Minimally improved
|
5 participants
|
4 participants
|
|
Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 12
No change
|
55 participants
|
35 participants
|
|
Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 12
Minimally worse
|
6 participants
|
0 participants
|
|
Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 12
Much worse
|
0 participants
|
0 participants
|
|
Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 12
Very much worse
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Baseline, Week 24Population: Safety analysis set; N=number of participants with analyzable data at observation.
CGI-I: 7-point clinician rated scale ranging from 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, to 7=very much worse. Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Scores above 4 reflect worsening of illness state as compared to baseline.
Outcome measures
| Measure |
Varenicline
n=61 Participants
Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
|
Placebo
n=37 Participants
Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
|
|---|---|---|
|
Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 24
Very much improved
|
2 participants
|
0 participants
|
|
Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 24
Much improved
|
2 participants
|
1 participants
|
|
Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 24
Minimally improved
|
8 participants
|
5 participants
|
|
Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 24
No change
|
46 participants
|
31 participants
|
|
Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 24
Minimally worse
|
2 participants
|
0 participants
|
|
Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 24
Much worse
|
1 participants
|
0 participants
|
|
Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 24
Very much worse
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Week 12Population: Full analysis set (FAS): all participants randomized into the study who received at least 1 dose of study treatment (formerly referred to as the All subjects analysis set).
7-day point prevalence of non-smoking measured as the number of participants who maintained complete abstinence from cigarette smoking or other nicotine use in the previous 7 days before the Week 12 visit and had an end-expiratory carbon monoxide (CO) measurement of ≤10 parts per million (ppm).
Outcome measures
| Measure |
Varenicline
n=84 Participants
Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
|
Placebo
n=43 Participants
Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
|
|---|---|---|
|
Number of Participants With 7-day Point Prevalence of Non-smoking at Week 12
|
16 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Week 24Population: FAS
7-day point prevalence of non-smoking measured as the number of participants who maintained complete abstinence from cigarette smoking or other nicotine use in the previous 7 days before the Week 24 visit and had an end-expiratory carbon monoxide (CO) measurement of ≤10 parts per million (ppm).
Outcome measures
| Measure |
Varenicline
n=84 Participants
Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
|
Placebo
n=43 Participants
Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
|
|---|---|---|
|
Number of Participants With 7-day Point Prevalence of Non-smoking at Week 24
|
10 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 24Population: FAS
Measured as at least a 50% reduction from baseline in cigarettes smoked per day averaged over the past 7 days at Week 12 and Week 24.
Outcome measures
| Measure |
Varenicline
n=84 Participants
Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
|
Placebo
n=43 Participants
Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
|
|---|---|---|
|
Number of Participants With at Least a 50 Percent (%) Reduction From Baseline to Week 12 and Week 24 in the Number of Cigarettes Smoked Per Day
Week 12
|
54 participants
|
22 participants
|
|
Number of Participants With at Least a 50 Percent (%) Reduction From Baseline to Week 12 and Week 24 in the Number of Cigarettes Smoked Per Day
Week 24
|
34 participants
|
18 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 24Population: FAS; (n)=number of participants with evaluable data at observation.
Measured as mean number of cigarettes smoked per day averaged over the past 7 days at Week 12 and Week 24.
Outcome measures
| Measure |
Varenicline
n=84 Participants
Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
|
Placebo
n=43 Participants
Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
|
|---|---|---|
|
Change From Baseline to Week 12 and Week 24 in the Number of Cigarettes Smoked Per Day
Week 12 (n=68, 39)
|
-14.23 cigarettes per day
Interval -15.95 to -12.51
|
-10.58 cigarettes per day
Interval -12.73 to -8.42
|
|
Change From Baseline to Week 12 and Week 24 in the Number of Cigarettes Smoked Per Day
Week 24 (n=61, 37)
|
-9.55 cigarettes per day
Interval -12.0 to -7.1
|
-9.32 cigarettes per day
Interval -12.36 to -6.28
|
Adverse Events
Varenicline
Placebo
Serious adverse events
| Measure |
Varenicline
n=84 participants at risk
Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
|
Placebo
n=43 participants at risk
Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
|
|---|---|---|
|
General disorders
Chest pain
|
1.2%
1/84 • Events assessed Baseline through Week 12 (treatment phase) plus a 30 day lag period after last dose of study treatment); Neuropsychiatric events assessed through Week 24.
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.
|
0.00%
0/43 • Events assessed Baseline through Week 12 (treatment phase) plus a 30 day lag period after last dose of study treatment); Neuropsychiatric events assessed through Week 24.
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.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/84 • Events assessed Baseline through Week 12 (treatment phase) plus a 30 day lag period after last dose of study treatment); Neuropsychiatric events assessed through Week 24.
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.
|
2.3%
1/43 • Events assessed Baseline through Week 12 (treatment phase) plus a 30 day lag period after last dose of study treatment); Neuropsychiatric events assessed through Week 24.
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/84 • Events assessed Baseline through Week 12 (treatment phase) plus a 30 day lag period after last dose of study treatment); Neuropsychiatric events assessed through Week 24.
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.
|
2.3%
1/43 • Events assessed Baseline through Week 12 (treatment phase) plus a 30 day lag period after last dose of study treatment); Neuropsychiatric events assessed through Week 24.
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.
|
|
Nervous system disorders
Convulsion
|
1.2%
1/84 • Events assessed Baseline through Week 12 (treatment phase) plus a 30 day lag period after last dose of study treatment); Neuropsychiatric events assessed through Week 24.
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.
|
0.00%
0/43 • Events assessed Baseline through Week 12 (treatment phase) plus a 30 day lag period after last dose of study treatment); Neuropsychiatric events assessed through Week 24.
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.
|
|
Psychiatric disorders
Aggression
|
0.00%
0/84 • Events assessed Baseline through Week 12 (treatment phase) plus a 30 day lag period after last dose of study treatment); Neuropsychiatric events assessed through Week 24.
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.
|
2.3%
1/43 • Events assessed Baseline through Week 12 (treatment phase) plus a 30 day lag period after last dose of study treatment); Neuropsychiatric events assessed through Week 24.
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.
|
|
Psychiatric disorders
Depression
|
1.2%
1/84 • Events assessed Baseline through Week 12 (treatment phase) plus a 30 day lag period after last dose of study treatment); Neuropsychiatric events assessed through Week 24.
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.
|
0.00%
0/43 • Events assessed Baseline through Week 12 (treatment phase) plus a 30 day lag period after last dose of study treatment); Neuropsychiatric events assessed through Week 24.
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.
|
|
Psychiatric disorders
Psychiatric symptom
|
1.2%
1/84 • Events assessed Baseline through Week 12 (treatment phase) plus a 30 day lag period after last dose of study treatment); Neuropsychiatric events assessed through Week 24.
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.
|
0.00%
0/43 • Events assessed Baseline through Week 12 (treatment phase) plus a 30 day lag period after last dose of study treatment); Neuropsychiatric events assessed through Week 24.
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.
|
|
Psychiatric disorders
Suicidal ideation
|
1.2%
1/84 • Events assessed Baseline through Week 12 (treatment phase) plus a 30 day lag period after last dose of study treatment); Neuropsychiatric events assessed through Week 24.
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.
|
2.3%
1/43 • Events assessed Baseline through Week 12 (treatment phase) plus a 30 day lag period after last dose of study treatment); Neuropsychiatric events assessed through Week 24.
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.
|
|
Psychiatric disorders
Suicide attempt
|
1.2%
1/84 • Events assessed Baseline through Week 12 (treatment phase) plus a 30 day lag period after last dose of study treatment); Neuropsychiatric events assessed through Week 24.
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.
|
0.00%
0/43 • Events assessed Baseline through Week 12 (treatment phase) plus a 30 day lag period after last dose of study treatment); Neuropsychiatric events assessed through Week 24.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.2%
1/84 • Events assessed Baseline through Week 12 (treatment phase) plus a 30 day lag period after last dose of study treatment); Neuropsychiatric events assessed through Week 24.
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.
|
0.00%
0/43 • Events assessed Baseline through Week 12 (treatment phase) plus a 30 day lag period after last dose of study treatment); Neuropsychiatric events assessed through Week 24.
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.
|
Other adverse events
| Measure |
Varenicline
n=84 participants at risk
Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
|
Placebo
n=43 participants at risk
Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.3%
7/84 • Events assessed Baseline through Week 12 (treatment phase) plus a 30 day lag period after last dose of study treatment); Neuropsychiatric events assessed through Week 24.
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.
|
2.3%
1/43 • Events assessed Baseline through Week 12 (treatment phase) plus a 30 day lag period after last dose of study treatment); Neuropsychiatric events assessed through Week 24.
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.
|
|
Gastrointestinal disorders
Diarrhoea
|
8.3%
7/84 • Events assessed Baseline through Week 12 (treatment phase) plus a 30 day lag period after last dose of study treatment); Neuropsychiatric events assessed through Week 24.
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.
|
4.7%
2/43 • Events assessed Baseline through Week 12 (treatment phase) plus a 30 day lag period after last dose of study treatment); Neuropsychiatric events assessed through Week 24.
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.
|
|
Gastrointestinal disorders
Nausea
|
23.8%
20/84 • Events assessed Baseline through Week 12 (treatment phase) plus a 30 day lag period after last dose of study treatment); Neuropsychiatric events assessed through Week 24.
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.
|
14.0%
6/43 • Events assessed Baseline through Week 12 (treatment phase) plus a 30 day lag period after last dose of study treatment); Neuropsychiatric events assessed through Week 24.
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.
|
|
Gastrointestinal disorders
Vomiting
|
10.7%
9/84 • Events assessed Baseline through Week 12 (treatment phase) plus a 30 day lag period after last dose of study treatment); Neuropsychiatric events assessed through Week 24.
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.
|
9.3%
4/43 • Events assessed Baseline through Week 12 (treatment phase) plus a 30 day lag period after last dose of study treatment); Neuropsychiatric events assessed through Week 24.
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.
|
|
General disorders
Fatigue
|
6.0%
5/84 • Events assessed Baseline through Week 12 (treatment phase) plus a 30 day lag period after last dose of study treatment); Neuropsychiatric events assessed through Week 24.
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.
|
4.7%
2/43 • Events assessed Baseline through Week 12 (treatment phase) plus a 30 day lag period after last dose of study treatment); Neuropsychiatric events assessed through Week 24.
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.
|
|
General disorders
Irritability
|
6.0%
5/84 • Events assessed Baseline through Week 12 (treatment phase) plus a 30 day lag period after last dose of study treatment); Neuropsychiatric events assessed through Week 24.
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.
|
7.0%
3/43 • Events assessed Baseline through Week 12 (treatment phase) plus a 30 day lag period after last dose of study treatment); Neuropsychiatric events assessed through Week 24.
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.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.1%
6/84 • Events assessed Baseline through Week 12 (treatment phase) plus a 30 day lag period after last dose of study treatment); Neuropsychiatric events assessed through Week 24.
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.
|
2.3%
1/43 • Events assessed Baseline through Week 12 (treatment phase) plus a 30 day lag period after last dose of study treatment); Neuropsychiatric events assessed through Week 24.
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.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.4%
2/84 • Events assessed Baseline through Week 12 (treatment phase) plus a 30 day lag period after last dose of study treatment); Neuropsychiatric events assessed through Week 24.
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.
|
7.0%
3/43 • Events assessed Baseline through Week 12 (treatment phase) plus a 30 day lag period after last dose of study treatment); Neuropsychiatric events assessed through Week 24.
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.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.6%
3/84 • Events assessed Baseline through Week 12 (treatment phase) plus a 30 day lag period after last dose of study treatment); Neuropsychiatric events assessed through Week 24.
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.
|
7.0%
3/43 • Events assessed Baseline through Week 12 (treatment phase) plus a 30 day lag period after last dose of study treatment); Neuropsychiatric events assessed through Week 24.
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.
|
|
Nervous system disorders
Headache
|
10.7%
9/84 • Events assessed Baseline through Week 12 (treatment phase) plus a 30 day lag period after last dose of study treatment); Neuropsychiatric events assessed through Week 24.
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.
|
18.6%
8/43 • Events assessed Baseline through Week 12 (treatment phase) plus a 30 day lag period after last dose of study treatment); Neuropsychiatric events assessed through Week 24.
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.
|
|
Psychiatric disorders
Abnormal dreams
|
7.1%
6/84 • Events assessed Baseline through Week 12 (treatment phase) plus a 30 day lag period after last dose of study treatment); Neuropsychiatric events assessed through Week 24.
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.
|
9.3%
4/43 • Events assessed Baseline through Week 12 (treatment phase) plus a 30 day lag period after last dose of study treatment); Neuropsychiatric events assessed through Week 24.
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.
|
|
Psychiatric disorders
Anxiety
|
4.8%
4/84 • Events assessed Baseline through Week 12 (treatment phase) plus a 30 day lag period after last dose of study treatment); Neuropsychiatric events assessed through Week 24.
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.
|
9.3%
4/43 • Events assessed Baseline through Week 12 (treatment phase) plus a 30 day lag period after last dose of study treatment); Neuropsychiatric events assessed through Week 24.
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.
|
|
Psychiatric disorders
Depression
|
3.6%
3/84 • Events assessed Baseline through Week 12 (treatment phase) plus a 30 day lag period after last dose of study treatment); Neuropsychiatric events assessed through Week 24.
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.
|
7.0%
3/43 • Events assessed Baseline through Week 12 (treatment phase) plus a 30 day lag period after last dose of study treatment); Neuropsychiatric events assessed through Week 24.
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.
|
|
Psychiatric disorders
Insomnia
|
9.5%
8/84 • Events assessed Baseline through Week 12 (treatment phase) plus a 30 day lag period after last dose of study treatment); Neuropsychiatric events assessed through Week 24.
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.
|
4.7%
2/43 • Events assessed Baseline through Week 12 (treatment phase) plus a 30 day lag period after last dose of study treatment); Neuropsychiatric events assessed through Week 24.
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER