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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Systematic Assessment of Response to Open-label Treatment With Varenicline in Depressed Outpatient Smokers

Conditions
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Depressive Disorder, Smoking

Intervention / Treatment
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* Drug: fixed dose varenicline
* Drug: varenicline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Failed to achieve full symptom remission with previous pharmacotherapy. Current tobacco users. Able to give written, informed consent. Exclusion Criteria: Past adverse reaction to varenicline. Renal failure or dialysis. Current pregnancy or breastfeeding.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: varenicline<br>open label varenicline | Drug: fixed dose varenicline<br>* 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.<br>* Other names: Chantix;Drug: varenicline<br>* up to 1 mg twice daily<br>* Other names: Chantix;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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varenicline, depression, anhedonia, smoking