Systematic Assessment of Response to Open-label Treatment With Varenicline in Depressed Outpatient Smokers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Change in Quick Inventory of Depressive Symptoms, 16 Question Self-report
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets DSM-IV symptoms criteria for a mood disorder including major depression [unipolar or bipolar], depressive disorder NOS, dysthymia, adjustment disorder with depressed mood, or substance-induced mood disorder.
- •Failed to achieve full symptom remission with previous pharmacotherapy.
- •Current tobacco users.
- •Able to give written, informed consent.
排除标准
- •Past adverse reaction to varenicline.
- •Renal failure or dialysis.
- •Current pregnancy or breastfeeding.
研究组 & 干预措施
varenicline
open label varenicline
干预措施: fixed dose varenicline (Drug)
varenicline
open label varenicline
干预措施: varenicline (Drug)
结局指标
主要结局
Change in Quick Inventory of Depressive Symptoms, 16 Question Self-report
时间窗: 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
次要结局
- Improvement on Patient and Clinician Clinical Global Impression Rating Scale (CGI)(6-8 weeks)
- Improvement on Snaith-Hamilton Pleasure Scale (SHAPS)(6-8 weeks)