Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Varenicline in Bipolar Depressed Patients (Varenicline)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00813800
Recruitment Status : Completed
First Posted : December 23, 2008
Results First Posted : January 30, 2012
Last Update Posted : January 30, 2012
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Mark Frye, Mayo Clinic

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Smoking
Bipolar Disorder
Depression
Intervention Drug: Varenicline
Enrollment 11
Recruitment Details 11 patients were enrolled from the community all with bipolar depression and the desire to stop smoking.
Pre-assignment Details 36 patients who were screened did not meet inclusion/exclusion criteria and excluded from participation.
Arm/Group Title Varenicline
Hide Arm/Group Description Open-label; subjects will receive a behavioral intervention in addition to Varenicline. Varenicline (Chantix®, Pfizer) is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4-7, and then to the maintenance dose of 1 mg twice daily for the 12 weeks of treatment.
Period Title: Overall Study
Started 11
Completed 5
Not Completed 6
Reason Not Completed
Screen Failure after Consent             2
Adverse Event             1
Worsening of depression             2
Physician Decision             1
Arm/Group Title Varenicline
Hide Arm/Group Description Open-label; subjects will receive a behavioral intervention in addition to Varenicline. Varenicline (Chantix®, Pfizer) is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4-7, and then to the maintenance dose of 1 mg twice daily for the 12 weeks of treatment.
Overall Number of Baseline Participants 11
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants
38.8  (14)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Female
5
  45.5%
Male
6
  54.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants
11
Brief Questionnaire of Smoking Urges (QSU-brief)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 11 participants
476  (89.3)
[1]
Measure Description: The USU-brief is used as a measure of craving or desire to smoke. It uses 10 “agree-disagree” statements in a rating scale, five covering need to smoke for relief and five covering positive desire to smoke for reward. Maximum score = 1000, indicates a high level of craving. Minimum score = 0, indicates no craving for smoking. Cox LS, Tiffany ST, Christen AG. Evaluation of the brief questionnaire of smoking urges (QSU-brief) in laboaratory and clinical setting. Nicotine & Tobacco Research (2001)3(1):7-16.
Cigarettes (per day)  
Mean (Standard Deviation)
Unit of measure:  Cigarettes
Number Analyzed 11 participants
15.8  (2)
Carbon Monoxide Breath Level   [1] 
Mean (Standard Deviation)
Unit of measure:  Ppm
Number Analyzed 11 participants
20  (4.6)
[1]
Measure Description: Measured by expired breath in parts per million (ppm). (0-10 = non smoker; 11-20 = light smoker; >20 = heavy smoker)
Montgomery-Asberg Depression Rating Scale (MADRS)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 11 participants
9.9  (1.5)
[1]
Measure Description: MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. Each item on the MADRS is scaled 0 through 6. Lowest score = 0, would indicate no depressive symptoms. Highest score = 60, indicating extreme depression. MADRS score > 20 is syndromal depression. Montgomery SA, Asberg M. A new depression scale designed to be sensitive to change. Br J Psychiatry 1979; 134:382-389.
Young Mania Rating Scale (YMRS)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 11 participants
1.9  (0.6)
[1]
Measure Description: YMRS is an eleven-item, multiple choice diagnostic questionnaire which psychiatrists use to measure the severity of manic episodes in patients already diagnosed with mania. Lowest score = 0, normal subject; Highest score = 60, highly manic subject. For this scale the following scores are associated with these grades of severity: mania (YMRS = 20), hypomania (YMRS = 12), under 5 is classified as non-manic. Young RC, Biggs JT, Ziegler Ve, Meyer DA. A rating scale for mania: reliability, validity and sensitivity. BR J Psychiatry 1978; 133:429-435.
1.Primary Outcome
Title Carbon Monoxide Breath Level at 12 Weeks
Hide Description Measured by expired breath in parts per million (ppm)
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT)
Arm/Group Title Varenicline
Hide Arm/Group Description:
Open-label; subjects will receive a behavioral intervention in addition to Varenicline. Varenicline (Chantix®, Pfizer) is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4-7, and then to the maintenance dose of 1 mg twice daily for the 12 weeks of treatment.
Overall Number of Participants Analyzed 5
Mean (Standard Deviation)
Unit of Measure: ppm
6  (2.1)
2.Secondary Outcome
Title Montgomery-Asberg Depression Rating Scale (MADRS) at 12 Weeks
Hide Description MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. Each item on the MADRS is scaled 0 through 6. Lowest score = 0, would indicate no depressive symptoms. Highest score = 60, indicating extreme depression. MADRS score > 20 is syndromal depression. Montgomery SA, Asberg M. A new depression scale designed to be sensitive to change. Br J Psychiatry 1979; 134:382-389.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT)
Arm/Group Title Varenicline
Hide Arm/Group Description:
Open-label; subjects will receive a behavioral intervention in addition to Varenicline. Varenicline (Chantix®, Pfizer) is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4-7, and then to the maintenance dose of 1 mg twice daily for the 12 weeks of treatment.
Overall Number of Participants Analyzed 5
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
6  (2.4)
3.Secondary Outcome
Title Young Mania Rating Scale (YMRS) at 12 Weeks
Hide Description YMRS is an eleven-item, multiple choice diagnostic questionnaire which psychiatrists use to measure the severity of manic episodes in patients already diagnosed with mania. Lowest score = 0, normal subject; Highest score = 60, highly manic subject. For this scale the following scores are associated with these grades of severity: mania (YMRS = 20), hypomania (YMRS = 12), under 5 is classified as non-manic. Young RC, Biggs JT, Ziegler Ve, Meyer DA. A rating scale for mania: reliability, validity and sensitivity. BR J Psychiatry 1978; 133:429-435.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT)
Arm/Group Title Varenicline
Hide Arm/Group Description:
Open-label; subjects will receive a behavioral intervention in addition to Varenicline. Varenicline (Chantix®, Pfizer) is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4-7, and then to the maintenance dose of 1 mg twice daily for the 12 weeks of treatment.
Overall Number of Participants Analyzed 5
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
4  (1.5)
Time Frame 12 weeks per participant
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Varenicline
Hide Arm/Group Description Open-label; subjects will receive a behavioral intervention in addition to Varenicline. Varenicline (Chantix®, Pfizer) is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4-7, and then to the maintenance dose of 1 mg twice daily for the 12 weeks of treatment.
All-Cause Mortality
Varenicline
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Varenicline
Affected / at Risk (%) # Events
Total   0/9 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Varenicline
Affected / at Risk (%) # Events
Total   5/9 (55.56%)    
Cardiac disorders   
Elevated blood pressure   1/9 (11.11%)  1
General disorders   
Lack of concentration   1/9 (11.11%)  1
Musculoskeletal and connective tissue disorders   
Compartmental Syndrome   1/9 (11.11%)  1
Psychiatric disorders   
Worsening Depression   2/9 (22.22%)  2
Indicates events were collected by systematic assessment
Small sample size; limitations finding participants with stable state within their bipolar disorder.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Mark Frye, MD
Organization: Mayo Clinic
Phone: 507-255-9391
Responsible Party: Mark Frye, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00813800     History of Changes
Other Study ID Numbers: 08-003471
First Submitted: December 22, 2008
First Posted: December 23, 2008
Results First Submitted: November 11, 2011
Results First Posted: January 30, 2012
Last Update Posted: January 30, 2012