A Randomised, Double-blind, Parallel-group, Active Controlled Study Evaluating the Efficacy of Vortioxetine Versus Desvenlafaxine in Adult Patients Suffering From Major Depressive Disorder With Partial Response to SSRI Treatment
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 605
- 试验地点
- 80
- 主要终点
- Change in Montgomery and Åsberg Depression Rating Scale (MADRS) total score
研究概览
简要总结
The purpose of this study is to compare the efficacy of vortioxetine versus desvenlafaxine after 8 weeks of treatment in patients that have tried one available treatment without getting the full benefit
详细描述
The study will consist of a screening period of up to 14 days before the Baseline Visit, followed by an 8-week Treatment Period with vortioxetine or desvenlafaxine. A Safety Follow-up Visit will be performed approximately 4 weeks after the Primary Outcome/Withdrawal Visit.
At Baseline, patients will be equally randomised (1:1) to 1 of the 2 treatment groups for an 8-week, double-blind Treatment Period.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient has a primary diagnosis of single or recurrent MDD, diagnosed according to DSM-5®. The current MDE must be confirmed using the Mini International Neuropsychiatric Interview (MINI).
- •The patient has a MADRS total score ≥24 at screening and baseline.
- •The patient has had the current MDE for ≥3 months and < 12 months.
- •The patient has been treated with an SSRI as monotherapy (citalopram, escitalopram, paroxetine, sertraline) for at least 6 weeks at licensed dose for the current MDE with a partial response and is a candidate for a switch in the investigator's opinion.
- •The patient wants to switch antidepressant treatment.
排除标准
- •The patient has any other disorder for which the treatment takes priority over treatment of MDD or is likely to interfere with study treatment or impair treatment compliance.
- •Other in- and exclusion criteria may apply
研究组 & 干预措施
Vortioxetine
8 weeks treatment
干预措施: Vortioxetine (Drug)
Desvenlafaxine
8 weeks treatment
干预措施: Desvenlafaxine (Drug)
结局指标
主要结局
Change in Montgomery and Åsberg Depression Rating Scale (MADRS) total score
时间窗: From baseline to Week 8
The Montgomery and Åsberg Depression Rating Scale (MADRS) is a 10-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). The total score of the 10 items ranges from 0 to 60, with higher values indicating worse outcome.
次要结局
- Remission (defined as a MADRS total score =<10)(At Week 8)
- Change in Digital Symbol Substitution Test (DSST) total score(From baseline to Week 8)
- Change in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) total score(From baseline to Week 8)
- Change in Q-LES-Q work subscale(From baseline to Week 8)
- Change in Q-LES-Q school/course subscale(From baseline to Week 8)
- Change in Q-LES-Q leisure time activities subscale(From baseline to Week 8)
- Change in MADRS anhedonia factor score(From baseline to Week 8)
- Clinical Global Impression Scale- Global Improvement (CGI-I) score(at Day 7,28,56)
- Response (defined as a => 50% decrease from baseline in MADRS total score)(At Week 8)
- The proportion number of Hard Choice/number of High Reward trials and number of Low choice/number of Low Reward trials when performing the Effort- Expenditure for Rewards Task (EEfRT)(From baseline to Week 8)
- Change in Clinical Global Impression - Severity of Illness (CGI-S) score(from baseline to Week 8)
- Change in Functioning Assessment Short Test (FAST) total score(From baseline to Week 8)
- Change in FAST sub-domain scores(From baseline to Week 8)
- Change in Q-LES-Q household duties subscale(From baseline to Week 8)
- Change in Q-LES-Q social relations subscale(From baseline to Week 8)