Sequential Use of Fluoxetine for Smokers with Elevated Depressive Symptoms

描述（由申请人提供）：吸烟者抑郁症状升高与戒烟失败可靠相关。虽然几种抗抑郁药物已证明对戒烟有效，但氟西汀在治疗抑郁症状水平升高的吸烟者方面特别有希望。我们最近完成了一项氟西汀治疗抑郁症状加重的吸烟者的随机临床试验，发现序贯使用氟西汀（在戒烟日期前8周开始）的戒烟结局上级同时使用氟西汀。然而，我们先前研究设计的一个局限性是，我们不能排除我们的发现可能是由于安慰剂效应或额外接触时间的影响。因此，在临床实践环境中推广这种方法之前，我们认为首先确定这是否是氟西汀的活性药理学作用至关重要。该研究是一项随机、双盲、安慰剂对照的氟西汀试验，按我们早期研究的顺序使用。本试验旨在检验主要假设，即在206名抑郁症状升高（CESD > 6）的吸烟者中，序贯抗抑郁药物治疗（20 mg.）氟西汀（FLUOXSEQ）在尼古丁透皮贴剂（ST-TNP）的短暂标准戒烟治疗前8周开始，并在整个过程中延长，与安慰剂药物（PLAC-SEQ）联合ST-TNP的序贯药物治疗相比，根据相同的治疗方案，将导致上级戒烟结果。将在整个治疗期间以及2个月、6个月和12个月随访时评估吸烟结局。将评估当前和过去的精神病诊断，以及抑郁症状，尼古丁戒断症状和相关情绪状态的变化。

DESCRIPTION (provided by applicant): Elevated depressive symptoms in smokers has reliably been associated with smoking cessation failure. While several antidepressant medications have demonstrated efficacy for smoking cessation, fluoxetine has specifically shown promise in the treatment of smokers with elevated levels of depressive symptoms. We recently completed a randomized clinical trial of fluoxetine for smokers with elevated depressive symptoms, and found that sequential use of fluoxetine (starting 8 weeks prior to quit date) resulted in superior smoking cessation outcomes compared to concurrent use of fluoxetine. However, one limitation of our prior study design is that we could not rule out the possibility that our findings may have been due to placebo effects or the effects of additional contact time. Therefore, before disseminating this approach in clinical practice settings, we believe that it is critical to first determine whether this is an active pharmacologic effect of fluoxetine. The proposed study is a randomized, double-blind, placebo controlled trial of fluoxetine, used sequentially as in our earlier study. This trial is intended to test the primary hypothesis that among 206 smokers with elevated depressive symptoms (CESD > 6), sequential antidepressant pharmacotherapy with (20 mg.) fluoxetine (FLUOXSEQ), begun 8 weeks prior to and extended throughout brief standard smoking cessation treatment with transdermal nicotine patch (ST-TNP), will result in superior smoking cessation outcomes compared to sequential pharmacotherapy with placebo medication (PLAC-SEQ) combined with ST-TNP, according to the identical treatment schedule. Smoking outcomes will be assessed throughout treatment and at 2-, 6- and 12-month follow-ups. Current and past psychiatric diagnoses will be assessed, as will changes in depressive symptoms, nicotine withdrawal symptoms and associated mood states.