Duloxetine for Social Anxiety Disorder: Prediction of Long Term Outcome
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Anxiety Symptoms as Assessed by Liebowitz Social Anxiety Scale
研究概览
简要总结
The purpose of this study is to examine the safety and efficacy of duloxetine for the treatment of social anxiety disorder.
详细描述
An expanding body of clinical experience and controlled trials has established the efficacy of serotonin selective reuptake inhibitors (SSRIs) and the serotonin norepinephrine reuptake inhibitor (SNRI) venlafaxine, for the treatment of social anxiety disorder, with paroxetine, sertraline and venlafaxine extended-release (XR), which are FDA approved for this indication. The newest SNRI, duloxetine, has been shown to be effective at doses of 60mg/day to 120mg/day for anxiety associated with depression, and is anticipated to be a broad spectrum agent for mood and anxiety disorders (Dunner, Goldstein, Mallinckrodt, Lu, & Detke, 2003). However, no data on the efficacy of duloxetine for Social Anxiety Disorder, nor guidance regarding time to response or predictors of response, is yet available. These questions are the focus of this proposal.
This is a two phase, 24-week research study in which participants who remain symptomatic at the end of one phase (6 weeks) enter into the next phase. In phase I, all participants receive 60mg/day of duloxetine (Cymbalta) for 6 weeks. Participants who continue to have anxiety symptoms will enter the 18-week Phase II, in which they continue taking 60 mg/day of duloxetine and they will also be randomly assigned (by chance, like a flip of a coin) to receive either an additional 60mg/day of duloxetine or placebo (contains no active medication).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female outpatients > 18 years of age with a primary psychiatric diagnosis of generalized social anxiety disorder as defined by DSM-IV criteria and an LSAS score >
- •Physical examination, electrocardiogram, and laboratory findings without clinically significant abnormalities.
- •Willingness and ability to comply with the requirements of the study protocol.
排除标准
- •Patient has a history of intolerance or lack of response to a treatment trial of duloxetine at highest tolerated dose (<120mg/day).
- •Patients with acute narrow angle glaucoma.
- •Pregnant women, lactating women, and women of childbearing potential who are not using medically accepted forms of contraception (e.g., IUD, oral contraceptives, barrier devices, condoms and foam, or implanted progesterone rods stabilized for at least 3 months).
- •Concurrent use of other psychotropic medications. Patients must discontinue regular benzodiazepine or antidepressant therapy at least one week (5 weeks for fluoxetine) prior to baseline. Concomitant beta-blockers are proscribed unless prescribed for a medical indication (e.g., hypertension, at a stable daily dose for > 1 month).
- •Patients with a history of failure to satisfactorily respond to >2 prior adequate treatment trials.
- •Significant personality dysfunction likely to interfere with study participation.
- •Serious medical illness or instability for which hospitalization may be likely within the next year.
- •Seizure disorders with the exception of a history of febrile seizures if they occurred during childhood, were isolated, and did not recur in adulthood.
- •Concurrent psychotherapy initiated within 2 months of baseline is prohibited. Ongoing psychotherapy of any duration directed specifically toward treatment of the social anxiety disorder is excluded. Prohibited psychotherapy includes cognitive behavioral therapy or psychodynamic therapy that focuses on exploring specific, dynamic causes of the phobic symptomatology and provides skills for their management. General supportive individual, couples, or family therapy greater than 2 months duration is acceptable.
- •Diagnosis of any of the following mental disorders as defined by the DSM-IV: a lifetime history of schizophrenia or any other psychosis, mental retardation, organic medical disorders or bipolar disorder; eating disorders in the past 6 months; alcohol or substance abuse in the past 3 months or dependence within the past 6 months.
- •Entry of patients with major depression, dysthymia, panic disorder, generalized anxiety disorder, post-traumatic stress disorder or obsessive-compulsive disorder will be permitted if the social anxiety disorder is judged to be the predominant disorder, in order to increase accrual of a clinically relevant sample.
- •Patients with significant suicidal ideation (MADRS item 10 score > 3) or who have enacted suicidal behaviors within 6 months prior to intake will be excluded from study participation and referred for appropriate clinical intervention.
研究组 & 干预措施
Duloxetine 60mg + Placebo for 18 Weeks
In Phase 2 participants were randomized to 60mg Duloxetine + Placebo or 120mg Duloxetine.
干预措施: Duloxetine (Drug)
Duloxetine 60mg + Placebo for 18 Weeks
In Phase 2 participants were randomized to 60mg Duloxetine + Placebo or 120mg Duloxetine.
干预措施: Placebo (Drug)
Duloxetine 120mg for 18 Weeks
In Phase 2 participants were randomized to 60mg Duloxetine + Placebo or 120mg Duloxetine.
干预措施: Duloxetine (Drug)
Duloxetine 60mg/day for 6 Weeks
In Phase 1 all participants entered an open trial.
干预措施: Duloxetine (Drug)
结局指标
主要结局
Anxiety Symptoms as Assessed by Liebowitz Social Anxiety Scale
时间窗: 6 months
The Liebowitz Social Anxiety Scale (LSAS; Liebowitz, 1987) is a 24-item scale that provides separate scores for fear and avoidance in social and performance situations with higher scores representing increased social anxiety. The LSAS contains three total scores: 1) total fear score (0-72), 2) total avoidance score(0-72), 3) and total overall score (0-144). Suggested interpretations: 55-65 Moderate social phobia, 65-80 Marked social phobia, 80-95 Severe social phobia, Greater than 95 - Very severe social phobia.
次要结局
- CGI-S(6 months)
研究者
Naomi M. Simon
Director, Center for Anxiety and Traumatic Stress Disorders
Massachusetts General Hospital