Trial · NCT00644969
Smoking Cessation Study for Patients With Schizophrenia or Schizoaffective Disorder
NCT00644969, Phase 3, Completed, Pfizer; results first posted 2011-04-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Smoking Cessation Study for Patients With Schizophrenia or Schizoaffective Disorder. Trials, record NCT00644969. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00644969
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Smoking Cessation Study for Patients With Schizophrenia or Schizoaffective Disorder
- NCT number
- NCT00644969
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 128 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Smoking Cessation
- Interventions
- placebo, varenicline (CP-526,555)
- First posted
- 2008-03-27
- Last updated
- 2011-04-15
- Results first posted
- 2011-04-15
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to 30 days after last dose of study treatment or up to Week 16 | 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. |
| Primary | Number of Participants With Psychiatric Adverse Events | Baseline up to 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. |
| Primary | Change From Baseline to Week 12 in Positive and Negative Syndrome Scale (PANSS): Total Score | Baseline to Week 12 | 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. |
| Primary | Change From Baseline to Week 24 in Positive and Negative Syndrome Scale (PANSS): Total Score | Baseline to Week 24 | 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. |
| Primary | Change From Baseline to Week 12 in Positive and Negative Syndrome Scale (PANSS): Positive Symptoms Score | Baseline to Week 12 | 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. |
| Primary | Change From Baseline to Week 24 in Positive and Negative Syndrome Scale (PANSS): Positive Symptoms Score | Baseline to Week 24 | 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. |
| Primary | Change From Baseline to Week 12 in Positive and Negative Syndrome Scale (PANSS): Negative Symptoms Score | Baseline to Week 12 | 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. |
| Primary | Change From Baseline to Week 24 in Positive and Negative Syndrome Scale (PANSS): Negative Symptoms Score | Baseline to Week 24 | 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. |
| Primary | Change From Baseline to Week 12 in Simpson Angus Rating Scale (SARS) | Baseline to Week 12 | 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. |
| Primary | Change From Baseline to Week 24 in Simpson Angus Rating Scale (SARS) | Baseline to Week 24 | 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. |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to 30 days after last dose of study treatment or up to Week 16 | 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). | participants | NUMBER |
| PRIMARY | Number of Participants With Psychiatric Adverse Events | Baseline up to Week 24 | 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. | participants | NUMBER |
| PRIMARY | Change From Baseline to Week 12 in Positive and Negative Syndrome Scale (PANSS): Total Score | Baseline to Week 12 | Safety analysis set; (n)=number of participants with analyzable data at observation for varenicline and placebo, respectively. | scores on a scale | MEAN |
| PRIMARY | Change From Baseline to Week 24 in Positive and Negative Syndrome Scale (PANSS): Total Score | Baseline to Week 24 | Safety analysis set; N=number of participants with analyzable data at observation. | scores on a scale | MEAN |
| PRIMARY | Change From Baseline to Week 12 in Positive and Negative Syndrome Scale (PANSS): Positive Symptoms Score | Baseline to Week 12 | Safety analysis set; (n)=number of participants with analyzable data at observation for varenicline and placebo, respectively. | scores on a scale | MEAN |
| PRIMARY | Change From Baseline to Week 24 in Positive and Negative Syndrome Scale (PANSS): Positive Symptoms Score | Baseline to Week 24 | Safety analysis set; N=number of participants with analyzable data at observation. | scores on a scale | MEAN |
| PRIMARY | Change From Baseline to Week 12 in Positive and Negative Syndrome Scale (PANSS): Negative Symptoms Score | Baseline to Week 12 | Safety analysis set; (n)=number of participants with analyzable data at observation for varenicline and placebo, respectively. | scores on a scale | MEAN |
| PRIMARY | Change From Baseline to Week 24 in Positive and Negative Syndrome Scale (PANSS): Negative Symptoms Score | Baseline to Week 24 | Safety analysis set; N=number of participants with analyzable data at observation. | scores on a scale | MEAN |
| PRIMARY | Change From Baseline to Week 12 in Simpson Angus Rating Scale (SARS) | Baseline to Week 12 | Safety analysis set; (n)=number of participants with analyzable data at observation for varenicline and placebo, respectively. | scores on a scale | MEAN |
| PRIMARY | Change From Baseline to Week 24 in Simpson Angus Rating Scale (SARS) | Baseline to Week 24 | Safety analysis set; N=number of participants with analyzable data at observation. | scores on a scale | MEAN |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 outcomesResults by group148
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Varenicline | Serious Adverse Events | 5 | participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Placebo | Serious Adverse Events | 4 | participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Varenicline | Adverse Events | 70 | participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Placebo | Adverse Events | 35 | participants | |
| Number of Participants With Psychiatric Adverse Events | Varenicline | Abnormal dreams | 6 | participants | |
| Number of Participants With Psychiatric Adverse Events | Placebo | Abnormal dreams | 4 | participants | |
| Number of Participants With Psychiatric Adverse Events | Varenicline | Aggression | 0 | participants | |
| Number of Participants With Psychiatric Adverse Events | Placebo | Aggression | 1 | participants | |
| Number of Participants With Psychiatric Adverse Events | Varenicline | Agitation | 0 | participants | |
| Number of Participants With Psychiatric Adverse Events | Placebo | Agitation | 1 | participants |
1 to 10 of 148Source ClinicalTrials.gov
See all 148 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Phase | STARTED | Varenicline | 85 | |
| Treatment Phase | STARTED | Placebo | 43 | |
| Treatment Phase | COMPLETED | Varenicline | 71 | |
| Treatment Phase | COMPLETED | Placebo | 40 | |
| Treatment Phase | NOT COMPLETED | Varenicline | 14 | |
| Treatment Phase | NOT COMPLETED | Placebo | 3 | |
| Post Treatment Phase | STARTED | Varenicline | 71 | |
| Post Treatment Phase | STARTED | Placebo | 40 | |
| Post Treatment Phase | COMPLETED | Varenicline | 61 | |
| Post Treatment Phase | COMPLETED | Placebo | 37 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events48
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain upper | Gastrointestinal disorders | Varenicline | 7 | 84 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo | 1 | 43 | |
| other | Diarrhoea | Gastrointestinal disorders | Varenicline | 7 | 84 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 2 | 43 | |
| other | Nausea | Gastrointestinal disorders | Varenicline | 20 | 84 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 6 | 43 | |
| other | Vomiting | Gastrointestinal disorders | Varenicline | 9 | 84 | |
| other | Vomiting | Gastrointestinal disorders | Placebo | 4 | 43 | |
| other | Fatigue | General disorders | Varenicline | 5 | 84 | |
| other | Fatigue | General disorders | Placebo | 2 | 43 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Varenicline | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Varenicline | 48 | 84 |
| Total, other adverse events | Placebo | 25 | 43 |
| Total, serious adverse events | Varenicline | 5 | 84 |
| Total, serious adverse events | Placebo | 4 | 43 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Varenicline vs Placebo: Number of Participants With Suicidal Behavior and / or Ideation (Yes Response) on the Columbia Suicide Severity Rating Scale (C-SSRS) During the Treatment Phase | Trial comparisons |
| Varenicline vs Placebo: Number of Participants With 7-day Point Prevalence of Non-smoking at Week 12 | Trial comparisons |
| Varenicline vs Placebo: Number of Participants With 7-day Point Prevalence of Non-smoking at Week 24 | Trial comparisons |
| Varenicline vs Placebo: 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 | Trial comparisons |
| Varenicline vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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