Clinical trial NCT00644969: Smoking Cessation Study for Patients With Schizophrenia or Schizoaffective Disorder
Official title: A Phase 3B 12-Week, Double -Blind, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of Varenicline Tartrate (CP-526,555) 1 mg BID for Smoking Cessation in Subjects With Schizophrenia and Schizoaffective Disorder.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Smoking Cessation
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-03-27
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Study will determine whether patients with schizophrenia or schizoaffective disorder can be helped to quit smoking safely while using varenicline and receiving smoking cessation counseling.

Detailed description: This is a safety study.

Eligibility criteria: Inclusion Criteria:

* Have a diagnosis (using the SCID-I/P at screening visit) of schizophrenia or schizoaffective disorder and judged to be stable (without hospitalization or acute exacerbation and functioning in society) on psychiatric treatment for at least the past 6 month.
* Current cigarette smokers (at least 15/day during the past year with no period of abstinence greater than 3 months in the past year) male or female, between the ages of 18 and 75 inclusive, who are motivated to stop smoking.
* Score 7 or higher on the Contemplation Ladder at the Screening, Week -1, and Baseline Visits.

Exclusion Criteria:

* PANSS score \>70 at Screen or Baseline Visit.
* Subjects hospitalized within the past six months due to suicidal ideation or suicidal behavior or subjects considered to have serious suicidal ideation or suicidal behavior within the past six moth.
* Subjects having active suicidal ideation or behavior identified at Screen, Week -1, or Baseline Visit.
* Subjects taking Bupropion.

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to 30 days after last dose of study treatment or up to Week 16
measure: Number of Participants With Psychiatric Adverse Events
timeFrame: Baseline up to Week 24
measure: Change From Baseline to Week 12 in Positive and Negative Syndrome Scale (PANSS): Total Score
timeFrame: Baseline to Week 12
measure: Change From Baseline to Week 24 in Positive and Negative Syndrome Scale (PANSS): Total Score
timeFrame: Baseline to Week 24
measure: Change From Baseline to Week 12 in Positive and Negative Syndrome Scale (PANSS): Positive Symptoms Score
timeFrame: Baseline to Week 12
measure: Change From Baseline to Week 24 in Positive and Negative Syndrome Scale (PANSS): Positive Symptoms Score
timeFrame: Baseline to Week 24
measure: Change From Baseline to Week 12 in Positive and Negative Syndrome Scale (PANSS): Negative Symptoms Score
timeFrame: Baseline to Week 12
measure: Change From Baseline to Week 24 in Positive and Negative Syndrome Scale (PANSS): Negative Symptoms Score
timeFrame: Baseline to Week 24
measure: Change From Baseline to Week 12 in Simpson Angus Rating Scale (SARS)
timeFrame: Baseline to Week 12
measure: Change From Baseline to Week 24 in Simpson Angus Rating Scale (SARS)
timeFrame: Baseline to Week 24
measure: Number of Participants With Suicidal Behavior and / or Ideation ("Yes" Response) on the Columbia Suicide Severity Rating Scale (C-SSRS) During the Treatment Phase
timeFrame: Week 1 to Week 12 (Treatment phase)
measure: 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
timeFrame: Week 13 to Week 24 (Post treatment phase)
measure: Number of Participants With Shift From Baseline to Week 12 in Clinical Global Impressions Scale-Severity (CGI-S) Score
timeFrame: Baseline (Bsl) to Week 12
measure: Number of Participants With Shift From Baseline to Week 24 in Clinical Global Impressions Scale-Severity (CGI-S) Score
timeFrame: Baseline to Week 24
measure: Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 1
timeFrame: Baseline, Week 1
measure: Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 12
timeFrame: Baseline, Week 12
measure: Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 24
timeFrame: Baseline, Week 24
Secondary outcomes:
measure: Number of Participants With 7-day Point Prevalence of Non-smoking at Week 12
timeFrame: Week 12
measure: Number of Participants With 7-day Point Prevalence of Non-smoking at Week 24
timeFrame: Week 24
measure: 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
timeFrame: Baseline, Week 12, Week 24
measure: Change From Baseline to Week 12 and Week 24 in the Number of Cigarettes Smoked Per Day
timeFrame: Baseline, Week 12, Week 24
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Farmington
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Worcester
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: New Brunswick
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Durham
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Pittsburgh
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Edmonton
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Mississauga
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Williams JM, Anthenelli RM, Morris CD, Treadow J, Thompson JR, Yunis C, George TP. A randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of varenicline for smoking cessation in patients with schizophrenia or schizoaffective disorder. J Clin Psychiatry. 2012 May;73(5):654-60. doi: 10.4088/JCP.11m07522.