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| Descriptive Information Fields | |||||||||
| Brief Title † | Study of Mood Effects of Varenicline (Chantix) in Depressed Outpatient Smokers | ||||||||
| 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. |
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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 Phase | |||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study | ||||||||
| Primary Outcome Measure † | Improvement on quick inventory of depressive symptoms, 16 question self-report. [ Time Frame: 6-8 weeks ] [ Designated as safety issue: No ] | ||||||||
| Secondary Outcome Measure † | 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 ] |
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| Condition † | Depressive Disorder Smoking Antidepressive Agents |
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| Intervention † | Drug: varenicline | ||||||||
| MEDLINE PMIDs | |||||||||
| Links | |||||||||
| Recruitment Information Fields | |||||||||
| Recruitment Status † | Completed | ||||||||
| Enrollment † | 18 | ||||||||
| Start Date † | September 2007 | ||||||||
| Completion Date | March 2008 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 65 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† | |||||||||
| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00525837 | ||||||||
| Organization ID | 0707-002 | ||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | Butler Hospital | ||||||||
| Collaborators †† | Brown University | ||||||||
| Investigators † |
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| Information Provided By | Butler Hospital | ||||||||
| Verification Date | May 2008 | ||||||||
| First Received Date † | September 4, 2007 | ||||||||
| Last Updated Date | May 28, 2008 | ||||||||
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