Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of Mood Effects of Varenicline (Chantix) in Depressed Outpatient Smokers

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: NCT00525837
Recruitment Status : Completed
First Posted : September 6, 2007
Results First Posted : May 23, 2011
Last Update Posted : November 28, 2018
Sponsor:
Collaborator:
Brown University
Information provided by (Responsible Party):
Butler Hospital

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Depressive Disorder
Smoking
Interventions Drug: fixed dose varenicline
Drug: varenicline
Enrollment 18
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Varenicline
Hide Arm/Group Description [Not Specified]
Period Title: Overall Study
Started 18
Completed 14
Not Completed 4
Arm/Group Title Varenicline
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants
47.8  (10.1)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Between 18 and 65 years Number Analyzed 18 participants
18
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Female
12
  66.7%
Male
6
  33.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 18 participants
18
1.Primary Outcome
Title Change in Quick Inventory of Depressive Symptoms, 16 Question Self-report
Hide Description

this is a 16-item self report questionnaire that measures depressive symptoms.

Improvement is reported in change in depressive score

score ranges from 0-27, with higher numbers indicating more severe symptom reporting.

change is calculated by baseline plus/minus the value at the later time point

Time Frame Baseline and every 2 weeks until 8 weeks or study endpoint
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Varenicline
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 18
Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
4.7
(2.6 to 6.8)
2.Secondary Outcome
Title Improvement on Snaith-Hamilton Pleasure Scale (SHAPS)
Hide Description Snaith-Hamilton Pleasure Scale (SHAPS; Snaith et al, 1995). The SHAPS is a 14-item scale that measures anhedonia, the inability to experience pleasure. The items cover the domains of: social interaction, food and drink, sensory experience, and interest/pastimes. A score of 2 or less constitutes a “normal” score, while an “abnormal” score is defined as 3 or more. Each item has four possible responses: strongly disagree, disagree, agree, or strongly agree. Either of the “disagree” responses score one point, and either of the “agree” responses score 0 points. Thus, the final score ranges from 0 to 14. The SHAPS has adequate construct validity and satisfactory test-retest reliability (ICC=0.70) (Franken et al, 2007). High internal consistency has also been reported (Cronbach’s alpha of 0.94) (Franken et al, 2007)
Time Frame 6-8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Varenicline
Hide Arm/Group Description:

open label varenicline

fixed dose varenicline: varenicline 0.5 mg po daily for days 1-3, 0.5 twice daily for days 4-7, 1 mg twice daily thereafter for study duration.

varenicline: up to 1 mg twice daily

Overall Number of Participants Analyzed 18
Mean (Standard Error)
Unit of Measure: score on a scale
24.9  (7.4)
3.Secondary Outcome
Title Improvement on Patient and Clinician Clinical Global Impression Rating Scale (CGI)
Hide Description

Reference:

Guy W, editor. ECDEU Assessment Manual for Psychopharmacology. 1976. Rockville, MD, U.S. Department of Health, Education, and Welfare

The CGI is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients).

Time Frame 6-8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Varenicline
Hide Arm/Group Description:

open label varenicline

fixed dose varenicline: varenicline 0.5 mg po daily for days 1-3, 0.5 twice daily for days 4-7, 1 mg twice daily thereafter for study duration.

varenicline: up to 1 mg twice daily

Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.1  (1.4)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Varenicline
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Varenicline
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Varenicline
Affected / at Risk (%) # Events
Total   0/18 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Varenicline
Affected / at Risk (%) # Events
Total   4/18 (22.22%)    
Gastrointestinal disorders   
gastrointestinal distress *  3/18 (16.67%)  3
Psychiatric disorders   
insomnia *  1/18 (5.56%)  1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Noah S. Philip MD
Organization: Butler Hospital
Phone: 401-455-6258
Responsible Party: Butler Hospital
ClinicalTrials.gov Identifier: NCT00525837     History of Changes
Other Study ID Numbers: 0707-002
First Submitted: September 4, 2007
First Posted: September 6, 2007
Results First Submitted: October 4, 2010
Results First Posted: May 23, 2011
Last Update Posted: November 28, 2018