Clinical trial NCT00525837: Study of Mood Effects of Varenicline (Chantix) in Depressed Outpatient Smokers
Official title: Systematic Assessment of Response to Open-label Treatment With Varenicline in Depressed Outpatient Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Disorder
Smoking
Keywords: varenicline
depression
anhedonia
smoking
Lead sponsor: Butler Hospital
Sponsor class: OTHER
Collaborators: name: Brown University
First posted: 2007-09-06
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Quick Inventory of Depressive Symptoms, 16 Question Self-report
timeFrame: Baseline and every 2 weeks until 8 weeks or study endpoint
Secondary outcomes:
measure: Improvement on Snaith-Hamilton Pleasure Scale (SHAPS)
timeFrame: 6-8 weeks
measure: Improvement on Patient and Clinician Clinical Global Impression Rating Scale (CGI)
timeFrame: 6-8 weeks
Other outcomes:
Locations:
city: Providence
country: United States
facility: Butler Hospital
state: Rhode Island
Study officials:
affiliation: Butler Hospital
name: Noah S Philip, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Butler Hospital
name: Lawrence H Price, MD
role: STUDY_DIRECTOR
References:
citation: 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.