Study of Mood Effects of Varenicline (Chantix) 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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Systematic Assessment of Response to Open-label Treatment With Varenicline in Depressed Outpatient Smokers|
- Change in Quick Inventory of Depressive Symptoms, 16 Question Self-report [ Time Frame: Baseline and every 2 weeks until 8 weeks or study endpoint ] [ Designated as safety issue: No ]
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
- Improvement on Snaith-Hamilton Anhedonia Scale [ Time Frame: 6-8 weeks ] [ Designated as safety issue: No ]
- Improvement on Patient and Clinician Clinical Global Impression Rating Scale (CGI) [ Time Frame: 6-8 weeks ] [ Designated as safety issue: No ]
- Tolerability of Varenicline Measured by Adverse Symptoms Checklist (SAFTEE-SI LCN Modified) [ Time Frame: 6-8 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||September 2007|
|Study Completion Date:||March 2008|
|Primary Completion Date:||March 2008 (Final data collection date for primary outcome measure)|
open label varenicline
Drug: fixed dose varenicline
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.
Other Name: ChantixDrug: varenicline
up to 1 mg twice daily
Other Name: Chantix
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00525837
|United States, Rhode Island|
|Providence, Rhode Island, United States, 02906|
|Principal Investigator:||Noah S Philip, MD||Butler Hospital|
|Study Director:||Lawrence H Price, MD||Butler Hospital|