Study of Mood Effects of Varenicline (Chantix) in Depressed Outpatient Smokers
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About
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.
Full 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.
Enrollment
Sex
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Volunteers
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
18 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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