Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Brown University | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| varenicline | Other | open label varenicline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fixed dose varenicline | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline and every 2 weeks until 8 weeks or study endpoint |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Noah S Philip, MD | Butler Hospital | Principal Investigator |
| Lawrence H Price, MD | Butler Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Butler Hospital | Providence | Rhode Island | 02906 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19323966 | Derived | Philip NS, Carpenter LL, Tyrka AR, Whiteley LB, Price LH. Varenicline augmentation in depressed smokers: an 8-week, open-label study. J Clin Psychiatry. 2009 Jul;70(7):1026-31. doi: 10.4088/jcp.08m04441. Epub 2009 Mar 24. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Varenicline |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Varenicline |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | 95% Confidence Interval | Units on a scale | Baseline and every 2 weeks until 8 weeks or study endpoint |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Varenicline |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| gastrointestinal distress | Gastrointestinal disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Noah S. Philip MD | Butler Hospital | 401-455-6258 | noah_philip@brown.edu |
Not provided
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D012907 | Smoking |
| D003863 | Depression |
| D059445 | Anhedonia |
| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
| D001526 | Behavioral Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068580 | Varenicline |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| varenicline | Drug | up to 1 mg twice daily |
|
|
| 6-8 weeks |
| 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). | 6-8 weeks |
| years |
|
| Age, Customized | Number | participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 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) | Posted | Mean | Standard Error | score on a scale | 6-8 weeks |
|
|
|
| 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). | Posted | Mean | Standard Deviation | units on a scale | 6-8 weeks |
|
|
|
| 0 |
| 18 |
| 4 |
| 18 |
| insomnia | Psychiatric disorders | Non-systematic Assessment |
|
Not provided
Not provided
| D019954 |
| Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011810 | Quinoxalines |