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



Status:Completed
Conditions:Depression, Depression, Smoking Cessation
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 65
Updated:11/30/2018
Start Date:September 2007
End Date:March 2008

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

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.

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.
We found this trial at
1
site
345 Blackstone Blvd
Providence, Rhode Island 02906
(401) 455-6200
Butler Hospital Founded in 1844, Butler Hospital is the state's only non-profit, free-standing psychiatric hospital...
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mi
from
Providence, RI
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