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

Butler Hospital18 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Depressive Disorder Smoking

Interventions

fixed dose vareniclineDRUG

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.

vareniclineDRUG

up to 1 mg twice daily

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Butler Hospital

Providence, Rhode Island, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

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

Data from ClinicalTrials.gov

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