Depressive Disorder, Smoking
Conditions
Keywords
varenicline, depression, anhedonia, smoking
Brief summary
This study will assess whether varenicline (chantix) has antidepressant properties when used in addition to other psychiatric medication. It will also assess whether varenicline improves the inability to feel pleasure (i.e. anhedonia), and if it is well-tolerated when used with psychiatric medications. Enrolled patients will be assessed for improved mood, improved anhedonia, overall sense of health, side effects as well as tobacco use for 6-8 weeks. Medication will be provided free of charge.
Detailed description
Outpatient smokers who are depressed despite current stable psychiatric medication regimens will be invited to participate. They will receive varenicline dosed according to FDA-approved smoking cessation regime; patients will be assessed using QIDS-SR16, snaith-hamilton anhedonia rating scale, SAFTEE and clinical global improvement self-report scales and clinician global improvement scales at the above time intervals. Concurrent medication, psychiatric and non-psychiatric, will be recorded, as will vital signs (BP, HR, weight) and tobacco use.
Interventions
DRUGfixed 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.
DRUGvarenicline
up to 1 mg twice daily
Sponsors
Brown University
Butler Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Meets DSM-IV symptoms criteria for a mood disorder including major depression \[unipolar or bipolar\], depressive disorder NOS, dysthymia, adjustment disorder with depressed mood, or substance-induced mood disorder. 2. Failed to achieve full symptom remission with previous pharmacotherapy. 3. Current tobacco users. 4. Able to give written, informed consent.
Exclusion criteria
1. Past adverse reaction to varenicline. 2. Renal failure or dialysis. 3. Current pregnancy or breastfeeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quick Inventory of Depressive Symptoms, 16 Question Self-report | Baseline and every 2 weeks until 8 weeks or study endpoint | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement on Snaith-Hamilton Pleasure Scale (SHAPS) | 6-8 weeks | 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) |
| Improvement on Patient and Clinician Clinical Global Impression Rating Scale (CGI) | 6-8 weeks | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Varenicline | 18 |
| Total | 18 |
Baseline characteristics
| Characteristic | Varenicline |
|---|---|
| Age, Continuous | 47.8 years STANDARD_DEVIATION 10.1 |
| Age, Customized Between 18 and 65 years | 18 participants |
| Region of Enrollment United States | 18 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 4 / 18 |
| serious Total, serious adverse events | 0 / 18 |
Outcome results
Primary
Change in Quick Inventory of Depressive Symptoms, 16 Question Self-report
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Varenicline | Change in Quick Inventory of Depressive Symptoms, 16 Question Self-report | 4.7 Units on a scale |
Secondary
Improvement on Patient and Clinician Clinical Global Impression Rating Scale (CGI)
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Varenicline | Improvement on Patient and Clinician Clinical Global Impression Rating Scale (CGI) | 2.1 units on a scale | Standard Deviation 1.4 |
Secondary
Improvement on Snaith-Hamilton Pleasure Scale (SHAPS)
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Varenicline | Improvement on Snaith-Hamilton Pleasure Scale (SHAPS) | 24.9 score on a scale | Standard Error 7.4 |