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: 7615102
• 负责人: JACK R CORNELIUS
• 金额: $ 31.68万
• 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 2013-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7615102
• 关键词: Acute; Address; Adolescence; Adolescent; Adult; Age; Alcohol consumption; Alcohol dependence; Antidepressive Agents; Applications Grants; Behavioral; Child; Chronic; Clinical; Cognitive Therapy; Comorbidity; Conduct Disorder; Data; Dependence; Development; Double-Blind Method; Drug usage; Employment Status; Evaluation; Fluoxetine; Follow-Up Studies; Funding; Gender; Goals; Intervention; Longitudinal Studies; Major Depressive Disorder; Mind; Motivation; National Institute on Alcohol Abuse and Alcoholism; Natural History; Outcome; Participant; Pattern; Persons; Pharmaceutical Preparations; Pharmacological Treatment; Phase; Pilot Projects; Placebo Control; Placebos; Population; Problem behavior; Psychotherapy; Randomized; Recording of previous events; Recruitment Activity; Relapse; Research; Research Design; Sampling; Selective Serotonin Reuptake Inhibitor; Symptoms; Therapeutic Effect; Time; Treatment outcome; United States Food and Drug Administration; Writing; adolescents with alcohol use disorders; alcohol abuse therapy; alcohol use disorder; base; comparative efficacy; depression; depressive symptoms; drinking; dual diagnosis; emerging adult; experience; follow up assessment; follow-up; open label; placebo controlled study; prospective; psychosocial; response; treatment as usual; treatment response; underage drinking

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（由申请人提供）：这是1 R 01 AA 015173-01的修订版。最近（2003年1月3日），氟西汀成为FDA批准的第一种SSRI抗抑郁药，用于治疗青少年和儿童的重度抑郁症（MDD）。然而，目前尚不清楚氟西汀的这种疗效是否扩展到合并酒精使用障碍（AUD）的患者，或者是否在长期随访评估中持续存在。许多问题仍然是关于长期的过程中，这种共病的青少年人口，因为没有研究迄今已解决这些关键的临床问题。在拟定的研究中，将进行第一项前瞻性长期自然随访研究，涉及正在完成我们正在进行的氟西汀双盲安慰剂对照急性期治疗研究（R 01 AA 13370）的共病DD/AUD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期研究后2年、2.5年、3年、3.5年和4年的评估。这项拟议研究所涉及的时间段涵盖了从青春期后期到成年早期的过渡，这是一个关键的发展时期，通常涉及一些青少年减少或停止饮酒，而其他人则过渡到终身依赖。本拟议研究的第一个目标是评价氟西汀与安慰剂治疗共病（MDD/AUD）青少年病理性饮酒和抑郁症状的3个月急性期疗程的长期疗效。我们假设氟西汀在急性期试验中显示的治疗效果将在随访评估中持续存在。本拟定研究的第二个目标是描述接受治疗的MDD/AUD青少年从青春期晚期向成年早期过渡的长期临床病程。 我们假设不同的结局轨迹是可识别的，并且这些轨迹中至少有一个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、完成急性期研究时的持续MDD、行为障碍史以及继续与停止心理治疗。