Study of Mood Effects of Varenicline (Chantix) in Depressed Outpatient Smokers
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| Tracking Information | |||||||||
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| First Received Date ICMJE | September 4, 2007 | ||||||||
| Last Updated Date | June 2, 2011 | ||||||||
| Start Date ICMJE | September 2007 | ||||||||
| Primary Completion Date | March 2008 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 |
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| Original Primary Outcome Measures ICMJE |
Improvement on quick inventory of depressive symptoms, 16 question self-report. [ Time Frame: 6-8 weeks ] | ||||||||
| Change History | Complete list of historical versions of study NCT00525837 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Study of Mood Effects of Varenicline (Chantix) in Depressed Outpatient Smokers | ||||||||
| Official Title ICMJE | 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arm (s) | varenicline
open label varenicline
Interventions:
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| Publications * | 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. Epub 2009 Mar 24. | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 18 | ||||||||
| Completion Date | March 2008 | ||||||||
| Primary Completion Date | March 2008 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 65 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00525837 | ||||||||
| Other Study ID Numbers ICMJE | 0707-002 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Lawrence H. Price, M.D., Butler Hospital | ||||||||
| Study Sponsor ICMJE | Butler Hospital | ||||||||
| Collaborators ICMJE | Brown University | ||||||||
| Investigators ICMJE |
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| Information Provided By | Butler Hospital | ||||||||
| Verification Date | June 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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