FLUOXETINE-TREATED AUD-MDD TEENS: LONG TERM OUTCOMES

氟西汀治疗的 AUD-MDD 青少年：长期结果

• 批准号: 6916824
• 负责人: JACK R CORNELIUS
• 金额: $ 33.41万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-05-15 至 2010-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6916824
• 关键词: adolescence (12-20); age difference; alcoholism /alcohol abuse; alcoholism /alcohol abuse therapy; antidepressants; behavior therapy; behavioral /social science research tag; blood tests; clinical research; clinical trials; comorbidity; conduct disorder; education; employment /unemployment; fluoxetine; gender difference; human subject; interview; longitudinal human study; major depression; patient oriented research; substance abuse related behavior; urinalysis; young adult human (21-34)

DESCRIPTION (provided by applicant): This is a revision of 1 R01 AA 015173-01. Recently (January 3, 2003), fluoxetine became the first SSRI antidepressant to be approved by the FDA for treatment of major depression (MDD) among adolescents and children. However, it is unclear whether this efficacy for fluoxetine extends to those with a comorbid alcohol use disorder (AUD), or whether it persists at long-term follow-up assessments. Many questions remain concerning the long-term course of this comorbid adolescent population, because no studies to date have addressed those crucial clinical questions. In the study being proposed, a first prospective long-term naturalistic follow-up study will be undertaken involving the comorbid DD/AUD) adolescents who are completing our ongoing double-blind placebocontrolled acute phase treatment study with fluoxetine (R01 AA13370). This proposed long-term naturalistic study will involve assessments at 2, 2.5, 3, 3.5, and 4 years following entry into our ongoing acute phase study. The time period involved in this proposed study covers the transition from late adolescence to early adulthood, which is a crucial developmental period that typically involves some adolescents decreasing or discontinuing alcohol use while others transition to lifelong dependence. The first goal of this proposed study is to evaluate the long-term efficacy of a previous 3-month acute phase course of fluoxetine versus placebo for the treatment of the pathological alcohol use and the depressive symptoms of comorbid (MDD/AUD) adolescents. We hypothesize that the therapeutic effects that fluoxetine demonstrated during the acute phase trial will persist at the follow-up assessments. The second goal of this proposed study is to characterize the long-term clinical course of treated MDD/AUD adolescents as they make the transition from late adolescence to early adulthood. We hypothesize that different outcome trajectories will be identifiable, and that at least one of those trajectories will be associated with the acute phase fluoxetine treatment. Other factors associated with those trajectories will include gender, age, persistent MDD at the completion of the acute phase study, a history of conduct disorder, and continuing vs. discontinuing psychotherapy.

描述(申请人提供)：这是R01 AA 015173-01的修订版。最近(2003年1月3日)，氟西汀成为第一个被FDA批准用于治疗青少年和儿童重度抑郁症(MDD)的SSRI抗抑郁药。然而，目前尚不清楚氟西汀的这种疗效是否延伸到患有酒精使用障碍(AUD)的患者，或者是否在长期随访评估中持续存在。关于这一并存的青少年人群的长期进程仍有许多问题，因为到目前为止还没有研究解决这些关键的临床问题。在拟议的研究中，将进行第一项前瞻性长期自然主义随访研究，对象为即将完成我们正在进行的氟西汀(R01 AA13370)双盲安慰剂对照急性期治疗研究的患有DD/AUD的青少年。这项拟议的长期自然主义研究将包括进入我们正在进行的急性阶段研究后的2年、2.5年、3年、3.5年和4年的评估。这项拟议研究涉及的时间段涵盖了从青春期晚期到成年期早期的过渡，这是一个关键的发育时期，通常涉及一些青少年减少或停止饮酒，而另一些青少年则过渡到终身依赖。这项拟议研究的第一个目标是评估之前3个月的急性期疗程氟西汀与安慰剂治疗病理性酒精使用和共病青少年抑郁症状(MDD/AUD)的长期疗效。我们假设，氟西汀在急性期试验中显示的疗效将在后续评估中持续存在。这项拟议研究的第二个目标是描述接受MDD/AUD治疗的青少年从青春期晚期过渡到成年期早期的长期临床病程。 我们假设不同的结果轨迹将是可识别的，并且这些轨迹中至少有一个将与急性期氟西汀治疗相关。与这些轨迹相关的其他因素包括性别、年龄、在急性期研究完成时持续存在的MDD、品行障碍史以及继续与停止心理治疗。