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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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.


Sponsor: Butler Hospital

Current Primary Outcome: Change in Quick Inventory of Depressive Symptoms, 16 Question Self-report [ Time Frame: Baseline and every 2 weeks until 8 weeks or study endpoint ]

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



Original Primary Outcome: Improvement on quick inventory of depressive symptoms, 16 question self-report. [ Time Frame: 6-8 weeks ]

Current Secondary Outcome:

  • Improvement on Snaith-Hamilton Anhedonia Scale [ Time Frame: 6-8 weeks ]
  • Improvement on Patient and Clinician Clinical Global Impression Rating Scale (CGI) [ Time Frame: 6-8 weeks ]
  • Tolerability of Varenicline Measured by Adverse Symptoms Checklist (SAFTEE-SI LCN Modified) [ Time Frame: 6-8 weeks ]


Original Secondary Outcome: Same as current

Information By: Butler Hospital

Dates:
Date Received: September 4, 2007
Date Started: September 2007
Date Completion:
Last Updated: October 3, 2014
Last Verified: October 2014