Fluoxetine for MDD/Cannabis Disorder in Young People

描述（由申请人提供）：本提案是对RFA-DA-04-014“大麻相关疾病药物开发”的回应。" 食品和药物管理局（FDA）最近（2003年1月3日）基于两项急性期双盲、安慰剂对照研究的结果批准氟西汀用于治疗青少年和儿童中的重度抑郁症（Emslie等人，1997; 2002）。氟西汀因此成为第一个获得FDA批准用于治疗青少年和儿童重度抑郁症（MDD）的抗抑郁药物。目前尚不清楚这些结果在多大程度上适用于患有MDD和物质使用障碍（SUD）（如大麻滥用或依赖）的青少年，因为患有SUD的青少年被排除在该研究之外。然而，我们自己的初步研究表明，氟西汀可安全有效地治疗抑郁症、大麻相关疾病以及合并症青少年和年轻人的饮酒（Cornelius et al，1999; 2001; 2004）。 在这项研究中，将进行第一项大规模前瞻性双盲、安慰剂对照研究，以评估SSRI药物氟西汀与安慰剂在治疗患有共病重度抑郁症和大麻相关疾病（MDD/CRD）的青少年中的疗效。两个治疗组中的所有受试者还将在急性期试验期间接受替代治疗（TAU），包括动机增强治疗（MET）和认知行为治疗（CBT）。本研究的目的是：1）比较SSRI药物氟西汀加TAU与安慰剂加TAU治疗青少年和年轻人大麻使用和抑郁症状的急性期（12周）疗效（12-25岁）患有CRD共病诊断的受试者样本（大麻依赖或大麻滥用）加MDD; 2）评估药物反应的特定预测因素; 3）对氟西汀在该共病人群中的长期疗效进行初步评价。

DESCRIPTION (provided by applicant): This proposal is in response to RFA-DA-04-014, "Medications Development for Cannabis-Related Disorder." The Food and Drug Administration (FDA) recently (January 3, 2003) approved fluoxetine for the treatment of major depression among adolescents and children, based on the results of two acute phase double-blind, placebo-controlled studies (Emslie et al., 1997; 2002). Fluoxetine thus became the first antidepressant medication to receive FDA approval for treatment of major depressive disorder (MDD) among adolescents and children. It is unclear to what extent those results apply to adolescents with comorbid MDD and a substance use disorder (SUD) such as cannabis abuse or dependence, since adolescents with SUDs were excluded from participation in that study. However, our own preliminary work suggests that fluoxetine is safe and effective for treating the depression, the cannabis related disorder, and the drinking of comorbid adolescents and young adults (Cornelius et al, 1999; 2001; 2004). In this study, a first large scale prospective double-blind, placebo-controlled study will be conducted to assess the efficacy of the SSRI medication fluoxetine vs. placebo in the treatment of adolescents with comorbid major depressive disorder and a cannabis related disorder (MDD/CRD). All subjects in both treatment groups will also receive Treatment As Usual (TAU) during the acute phase trial, which will consist of motivation enhancement therapy (MET) and Cognitive Behavioral Therapy (CBT). The goals of this study are: 1) to compare the acute phase (12 week) efficacy of the SSRI medication fluoxetine plus TAU vs. placebo plus TAU for the treatment of the cannabis use and the depressive symptoms of an adolescent and young adult (ages 12-25) sample of subjects with comorbid diagnoses of a CRD (cannabis dependence or cannabis abuse) plus MDD; 2) to assess specific predictors of medication response; 3) to perform a preliminary evaluation of the longer-term efficacy of fluoxetine in this comorbid population.