Trial Outcomes & Findings for Study of Mood Effects of Varenicline (Chantix) in Depressed Outpatient Smokers (NCT NCT00525837)
NCT ID: NCT00525837
Last Updated: 2018-11-28
Results Overview
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
COMPLETED
NA
18 participants
Baseline and every 2 weeks until 8 weeks or study endpoint
2018-11-28
Participant Flow
Participant milestones
| Measure |
Varenicline
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Mood Effects of Varenicline (Chantix) in Depressed Outpatient Smokers
Baseline characteristics by cohort
| Measure |
Varenicline
n=18 Participants
|
|---|---|
|
Age, Continuous
|
47.8 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
|
Age, Customized
Between 18 and 65 years
|
18 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and every 2 weeks until 8 weeks or study endpointthis 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
Outcome measures
| Measure |
Varenicline
n=18 Participants
|
|---|---|
|
Change in Quick Inventory of Depressive Symptoms, 16 Question Self-report
|
4.7 Units on a scale
Interval 2.6 to 6.8
|
SECONDARY outcome
Timeframe: 6-8 weeksSnaith-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)
Outcome measures
| Measure |
Varenicline
n=18 Participants
|
|---|---|
|
Improvement on Snaith-Hamilton Pleasure Scale (SHAPS)
|
24.9 score on a scale
Standard Error 7.4
|
SECONDARY outcome
Timeframe: 6-8 weeksReference: 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).
Outcome measures
| Measure |
Varenicline
n=14 Participants
|
|---|---|
|
Improvement on Patient and Clinician Clinical Global Impression Rating Scale (CGI)
|
2.1 units on a scale
Standard Deviation 1.4
|
Adverse Events
Varenicline
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Varenicline
n=18 participants at risk
|
|---|---|
|
Gastrointestinal disorders
gastrointestinal distress
|
16.7%
3/18 • Number of events 3
|
|
Psychiatric disorders
insomnia
|
5.6%
1/18 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place