Vilazodone for Separation Anxiety Disorder
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Clinical Global Impression-Improvement Scale
研究概览
简要总结
The purpose of this study is to determine whether Vilazodone (Viibryd), an SSRI and 5HT1a receptor agonist, is effective in treating Adult Separation Anxiety Disorder over a 12-week treatment course.
详细描述
In this randomized clinical trial, 40 adults with a principal diagnosis of Adult Separation Anxiety Disorder (ASAD) and no major depression or substance abuse disorders will be randomized to 12 weeks of treatment with vilazodone (flexibly dosed) or matched pill placebo. Outcome will be assessed in respect to symptomatic improvement, quality of life, adverse events and safety.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current primary (most clinically significant) diagnosis of DSM5 ASAD
- •Able to give consent, fluent in English
排除标准
- •Past or current DSM-IV diagnosis of any psychotic disorder; organic mental disorder or other cognitive disorder; bipolar disorder; or antisocial personality disorder. Current MDD of moderate or greater severity. Any other current primary Axis I disorder.
- •Recent history (past 3 months) of substance or alcohol abuse or dependence (other than nicotine or caffeine)
- •Suicidal ideation or behavior (in the past year) that poses a significant danger to the subject
- •Medical illness that could significantly increase risk of vilazodone treatment or interfere with assessment of diagnosis or treatment response, including organic brain impairment from stroke, CNS tumor, or demyelinating disease; renal impairment; diabetes mellitus
- •Current or past history of seizure disorder (except febrile seizure in childhood)
- •History of non-response to ≥ 2 serotonergic reuptake inhibitor antidepressants (SSRIs and/or SNRIs) for the treatment of ASAD after adequate treatment trials (adequate treatment is defined as at least 8 weeks at an adequate dose[s] based on approved package insert recommendations)
- •Currently taking medication which has been effective for patient's ASAD
- •For patients taking any ineffective psychoactive drug or herbal remedy, inability to tolerate or unwillingness to accept a drug-free period prior to beginning the study of 2 weeks or 5 half-lives (whichever is longer) before beginning study treatment, or ever having been treated with a depot antipsychotic. Fluoxetine washout period will be at least 5 weeks.
- •Requiring concomitant treatment with any prohibited medications, supplements, or herbal remedies, except for zolpidem, or zolpidem extended release for insomnia, which may be continued provided the medication has been used in a consistent manner for 4 weeks prior to randomization
- •History of intolerance or hypersensitivity to vilazodone, SNRIs or SSRIs
- •History of light therapy, electroconvulsive therapy, vagus nerve stimulation, transcranial magnetic stimulation, or any other experimental procedure for central nervous system disorders within 6 months of beginning this study
- •Pregnancy, lactation; for women of childbearing potential, not using an effective birth control method (e.g., oral contraceptive or double barrier method) for the duration of the study
- •Current formal psychotherapy initiated within 3 months of beginning this study. This includes: psychodynamic, cognitive-behavioral and interpersonal therapies
研究组 & 干预措施
Vilazodone
Vilazodone treatment. Dosage will begin at 10mg/day and will be increased to 20mg/day after 1 week, and 40mg/day after two weeks (optional). Dosage can be held steady or lowered at any time during the study as clinically indicated in the event of adverse effects. Twelve weeks of treatment, total.
干预措施: Vilazodone (Drug)
Placebo
Pill placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Clinical Global Impression-Improvement Scale
时间窗: Up to 12 weeks
Clinical Global Impression-Improvement Scale rating at week 12 A quickly administered and widely used observer rating, with ratings from 1 (very much improved) to 7 (very much worse). "Responder" is a score of 1 or 2.
次要结局
- Change From Baseline Hamilton Rating Scale for Depression 17-item Total Score(Up to 12 weeks)
- Change From Baseline in Attachment Style Questionnaire Score(Up to 12 weeks)
- Change From Baseline in Quality of Life Enjoyment & Satisfaction Questionnaire(Up to 12 weeks)
- Change From Baseline on Structured Clinical Interview for Separation Anxiety Disorder(Baseline and week 12)
- Change From Baseline on Adult Separation Anxiety - 27 Scale(Up to 12 weeks)