A Randomized, Double-Blind, 8-week Comparing Safety and Tolerability of Switching From Generic Selective Serotonin Reuptake Inhibitors (SSRIs) and Selective Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs) to Three Different Dose Initiation Strategies With Vilazodone
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in Total MADRS Scores From Baseline to Week 8
研究概览
简要总结
This is an 8-week, randomized, double blind, parallel group, 3-arm trial to compare 10 mg/day, 20 mg/day and 40 mg/day as starting doses of vilazodone following a switch from generic SSRIs and SNRIs. Vilazodone HCl under the trade name Viibryd™ is approved by the U.S. FDA for the treatment of major depressive disorder in adults. The purpose of this study is to evaluate the efficacy (how well the drug works), safety (the side effects), and tolerability (how well tolerated) of Vilazodone in preventing relapse or recurrence of depression. As vilazodone is not approved by the United States Food and Drug Administration (FDA) to prevent the recurrence of depression, for the purposes of this study it is considered investigational. The word "investigational" means that the study drug is still being tested in research studies and has not been approved for this use by the FDA.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years inclusive
- •DSM-IV Diagnosis of major depressive disorder
- •If female, nonpregnant/nonlactating
- •If a sexually active female of reproductive potential, must be using adequate contraception (i.e., oral contraceptives, barrier protection, or prior tubal ligation)
- •Inadequate response to antidepressants: having a score of ≥14 on the 17-item HAMD or a CGI-S score of ≥ 3 after a retrospective confirmation of an adequate trial of a single antidepressant (defined as an 6-week trial of acceptable therapeutic dose [40 mg of fluoxetine, paroxetine 30 mg of citalopram, 20 mg of escitalopram, 37.5 mg of paroxetine CR, 150 mg of sertraline, 100 mg of fluvoxamine, 225 mg of venlafaxine XR)
- •Lack of tolerability of antidepressants: Patient reports of side effects that are judged to be clinically meaningful by the investigator
- •HAMD item 2 score ≥ 2 at screening
- •Duration of current MDD ≥ 4 weeks and < 24 months
排除标准
- •Any Axis I disorder within previous six months of screening except Generalized Anxiety Disorder, Social Anxiety Disorder, Panic Disorder and Simple Phobias
- •MDD with postpartum onset, psychotic features or seasonal features
- •DSM-IV substance abuse or dependence in the previous 6 months
- •Medically unstable as judged by study investigators on clinical and/or laboratory findings
- •Lack of capacity to provide informed, written, consent to investigators
- •Previous intolerance to vilazodone or current use of vilazodone at screening or within 3 months of study entry
- •Significant suicide risk as judged by the investigator based on information collected on the Columbia Suicide Severity Rating Scale (CSSRS)
- •History of augmentation with atypical antipsychotics, lithium, T3 or another antidepressant within 3 months of screening
- •Failure of ≥ 3 adequate trials of different antidepressants for the current episode of MDD
- •Concomitant medications: All medications for pre existing medical conditions will be permitted to continue unchanged provided subjects are on a stable dose of at least 12 weeks. Subjects on concomitant mood stabilizers or atypical antipsychotics will require a 2-week washout prior to screening visit. Subjects on a minimum of 3 month of stable dose of hypnotics (e.g. zolpidem 10 mg per day or benzodiazepine dose of ≤ 2 mg per day of lorazepam or trazodone ≤ 100 mg per day or quetiapine ≤ 100 mg per day) will be allowed to continue their hypnotic medication at the same dose. Quetiapine at doses ≤ 100 mg per day is appropriate only for hypnotic effects. Over the counter medications will be permitted if in the opinion of the investigator, they are not considered to have any significant impact on the study. Any medication that has the potential to cause a clinical significant drug interaction with vilazodone in the judgment of the investigator will require a washout.
研究组 & 干预措施
Vilazodone 10mg
Vilazodone 10 mg/d arm (10mg/d initiation dose, titrated to 40 mg/d in 2 weeks, continued for 8 week trial)
干预措施: Vilazodone (Drug)
Vilazodone 20mg
vilazodone 20 mg arm (20mg/d initiation dose, titrated to 40 mg/d in 1 week, continued for 8-week trial)
干预措施: Vilazodone (Drug)
Vilazodone 40mg
vilazodone 40 mg/d arm (40 mg/d initiation and continuation dose for 8-week trial.
干预措施: Vilazodone (Drug)
结局指标
主要结局
Change in Total MADRS Scores From Baseline to Week 8
时间窗: Baseline, Week 8
The efficacy of switching to three different doses of vilazodone (10 mg/d, 20 mg/d, 40 mg/d) from equivalent dose range of generic SSRIs or SSNRIs in patients with MDD measured by the MADRS. The MADRS is a 10-item scale that evaluates the core symptoms and cognitive features of clinical depression. Each MADRS item is rated on a 0 to 6 scale. The MADRS Total score ranges from 0 (min) to 60 (max). Higher MADRS scores indicate higher levels of depressive symptoms.
Change in the Discontinuation Emergent Signs and Symptoms Check List (DESS)
时间窗: Baseline, week 9
DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The primary tolerability measure for discontinuation symptoms will be The Discontinuation Emergent Signs and Symptoms Check List (DESS). Discontinuation symptoms that do not respond to education and supportive psychotherapy will be managed by reinstituting the last dose of Vilazodone at which patients did not experience discontinuation symptoms and slowly tapering the dose over 1 week or longer, if necessary. Total possible range is 0 to 172. A higher score indicates more symptoms.
Change in Safety as Assessed by the Arizona Sexual Experience Scale (ASEX)
时间窗: Baseline, Weeks 8
The Arizona Sexual Experience Scale (ASEX) is a 5-item, patient selfrated scale that evaluates a patient's recent sexual experience. Patients are asked to assess their own experience over the last week (for example, "How strong is your sex drive?", "Are your orgasms satisfying?") and respond on a 6-point scale for each item. The ASEX is used to identify individuals with sexual dysfunction. Possible total score ranges from 5 to 30, with the higher score indicating more patient sexual dysfunction.
次要结局
- Change in Hamilton Anxiety Rating Scale (HAM-A) Total Scores(Baseline, 8 weeks)
- Change in Sheehan Disability Scale (SDS)(Baseline, 8 week)
- Change in Clinical Global Impression-Improvement (CGI-I) Scale(Baseline, Week 8)
- Change in Clinical Global Impression-Severity (CGI-S) Scale(Baseline, 8 week)
- MADRS Response(Baseline, Week 8)
- MADRS Remission(Week 8)