FLUOXETINE-TREATED AUD-MDD TEENS: LONG TERM OUTCOMES

氟西汀治疗的 AUD-MDD 青少年：长期结果

基本信息

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
项目类别：
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

项目摘要

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 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适用于合并酒精使用障碍（AUD）的患者，或者在长期随访评估中是否持续存在。关于这种共病青少年群体的长期病程，仍然存在许多问题，因为迄今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，将开展第一项前瞻性长期自然随访研究，对象是患有 DD/AUD) 共病的青少年，他们正在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。这项拟议的长期自然研究将涉及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。这项拟议研究涉及的时期涵盖了从青春期晚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氟西汀与安慰剂之前 3 个月急性期疗程治疗共病 (MDD/AUD) 青少年病理性饮酒和抑郁症状的长期疗效。我们假设氟西汀在急性期试验中表现出的治疗效果将在后续评估中持续存在。这项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时的长期临床病程。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之一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、急性期研究完成时的持续性MDD、行为障碍病史以及继续与停止心理治疗。