N/A
N=18
Study of Mood Effects of Varenicline (Chantix) in Depressed Outpatient Smokers
Depressive Disorder · Smoking
Bottom Line
View on ClinicalTrials.gov: NCT00525837 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
May 2011
Primary outcome: Primary: Change in Quick Inventory of Depressive Symptoms, 16 Question Self-report — 4.7 Units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- fixed dose varenicline (Drug); varenicline (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Butler Hospital
- Primary completion
- Mar 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Quick Inventory of Depressive Symptoms, 16 Question Self-report |
4.7 | — |
| SECONDARY Improvement on Snaith-Hamilton Pleasure Scale (SHAPS) |
24.9 | — |
| SECONDARY Improvement on Patient and Clinician Clinical Global Impression Rating Scale (CGI) |
2.1 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00525837). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.