NCT00525837

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Butler Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Depressive Disorder
• Smoking

Interventions

Type	Name	Description
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.
DRUG	varenicline	up to 1 mg twice daily

Timeline

• Start date: 2007-09-01
• Primary completion: 2008-03-01
• Completion: 2008-03-01
• First posted: 2007-09-06
• Last updated: 2018-11-28
• Results posted: 2011-05-23

Locations

1 site across 1 country: United States