NCT02389816已完成3 期
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase III Study to Evaluate the Efficacy and Safety of Once Daily Oral Lu AA21004 in Patients With Major Depressive Disorder
Takeda0 个研究点目标入组 493 人开始时间: 2015年4月10日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 493
- 主要终点
- Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score to Week 8
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of two fixed doses of vortioxetine (Lu AA21004; 10 or 20 mg/day) after 8 weeks of treatment in patients with major depressive disorder (MDD) in Japan.
详细描述
This is a randomized, double-blind, placebo-controlled, parallel-group, phase III study to assess the efficacy and safety of 8-week treatment of two fixed doses of Vortioxetine (Lu AA21004; 10 or 20 mg/day) in Japanese participants with major depressive disorder (MDD).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In the opinion of the investigator or sub-investigator, the participant is capable of understanding and complying with protocol requirements.
- •The participant signs and dates a written, informed consent form prior to the initiation of any study procedures.
- •The participant suffers from recurrent MDD as the primary diagnosis according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria (classification code 296.3x).
- •The participant is a man or a woman aged 20 to 75 years (both inclusive) at the time of informed consent.
- •The reported duration of the current major depressive episode is 3 to 12 months (both inclusive) at the start of screening period.
- •The participant has a MADRS total score ≥26, Hamilton Depression Rating Scale (HAM-D17) total score ≥18, and Clinical global impression scale-Severity (CGI-S) score ≥4 at the start of screening period, at the start of placebo lead-in period and at the start of double-blind treatment period.
- •A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use routinely adequate contraception from signing of informed consent to the end of the follow-up period.
排除标准
- •The participant has any following current or past history of psychiatric disorder and/or neurological disorder:
- •Any current psychiatric disorder other than MDD as defined by DSM-IV-TR (To be assessed by Mini International Neuropsychiatric Interview: MINI). A participant who exhibits symptoms of anxiety is eligible unless the participant fulfills the diagnostic criteria for a current anxiety disorder per DSM-IV-TR.
- •Current diagnosis or history of manic, mixed or hypomanic episode, MDD with psychotic features, schizophrenia or any other psychotic disorder (including substance-related mental disorders, or mental disorders due to a general medical condition) as defined by DSM-IV-TR.
- •Current diagnosis or history of any substance-related disorder (except nicotine and caffeine-related disorders) as defined by DSM-IV-TR.
- •The participant with a positive urine drug screening result at the start of screening period or the start of placebo lead-in period. In case that a participant showed positive test result at the start of screening period because the test was conducted before washout of pretreatment drug, the participant is eligible as long as he/she shows negative result at the start of placebo lead-in period.
- •Presence or history of any clinically significant neurological disorder (including epilepsy).
- •Any neurodegenerative disorder (e.g. Alzheimer's disease, Parkinson's disease, multiple sclerosis, Huntington's disease).
- •Any DSM-IV-TR axis II disorder.
- •The participant has the current or previous major depressive episode which was considered by the investigator or sub-investigator to have been resistant to 2 or more adequate antidepressants treatments of at least 6 weeks duration each at sufficient doses.
- •The participant has received any augmentation therapy (e.g. lithium, T3/T4, lamotrigine, sodium valproate, carbamazepine, additional atypical antipsychotic, or concomitant use of other antidepressant, etc.) for the current major depressive episode.
- •In the opinion of the investigator or sub-investigator, the participant has experienced significant number of major depressive episodes in the past, and is suspected of disease other than MDD.
- •In the opinion of the investigator or sub-investigator, the participant has experienced the first major depressive episode at his/her young age, and is suspected of disease other than MDD.
- •The participant has a MADRS total score at the start of double-blind treatment period that has improved or aggravated by 25% or more from the score at the start of placebo lead-in period.
- •The participant is significantly non-compliant with the study drug in the placebo lead-in period; e.g., not taking the study drug for 6 or more consecutive days.
- •The participant has received electroconvulsive therapy, vagus nerve stimulation, or repetitive transcranial magnetic stimulation therapy within 6 months prior to the screening period, or plans to initiate such therapy during the study.
- •The participant is receiving cognitive-behavioral therapy or psychotherapy at the time of informed consent, or plans to initiate such therapy during the study.
- •The participant is at significant risk of suicide or has a score ≥5 on Item 10 (suicidal thoughts) of the MADRS at the start of screening period, at the start of placebo lead-in period or at the start of double-blind treatment period, or has attempted suicide within 6 months prior to the start of screening period.
- •The participant has experienced any environmental change (e.g. temporary retirement, returnment, change of residence) considered by the investigator or sub-investigator to have the potential to impact on the efficacy evaluation, or plans such environmental changes during the study.
- •The participant is currently receiving drug therapy for thyroid dysfunction.
- •The participant is currently receiving hormonal therapy for gynecological disease.
- •The participant has taken excluded medications during the protocol-specified period, or will require to take excluded medications during the study.
- •The participant has previously received vortioxetine.
- •The participant has received study drug in a previous clinical study of Lu AA21004 (including this study).
- •The participant has a clinically significant chronic liver disease.
- •The participant has a history of severe allergy or hypersensitivity to drugs.
- •The participant has a clinically significant unstable illness, for example, liver disorder or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, rheumatologic, immunologic, infectious, neoplastic, skin and subcutaneous tissue disorders, eye disorders, or metabolic disturbance.
- •The participant has clinically significant abnormal vital signs as determined by the investigator or sub-investigator at the start of screening period, placebo lead-in period, or double-blind treatment period.
- •The participant has clinically significant abnormal electrocardiogram (ECG) as determined by the investigator or sub-investigator, at the start of the screening period, at the start of placebo lead-in period, or at the start of double-blind treatment period.
- •The participant has clinically significant abnormal findings of clinical laboratory tests as determined by the investigator or sub-investigator, or has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2 × ULN at the start of screening period or at the start of placebo lead-in period.
- •If female, the participant is pregnant or lactating.
- •The participant has a disease or takes medications that could, in the opinion of the investigator or sub-investigator, interfere with the evaluation of the safety, tolerability, or efficacy.
- •The participant is, in the opinion of the investigator or sub-investigator, unsuitable for this study for any other reason.
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo tablets, orally, once daily for up to Week 8
干预措施: Placebo (Drug)
Vortioxetine 10 mg
Experimental
Vortioxetine 10 mg tablets, orally, once daily for up to Week 8
干预措施: Vortioxetine (Drug)
Vortioxetine 20 mg
Experimental
Vortioxetine 10 mg tablets, orally, once daily for up to Week 1 followed by vortioxetine 20 mg tablets, orally, once daily for up to Week 8
干预措施: Vortioxetine (Drug)
结局指标
主要结局
Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score to Week 8
时间窗: Baseline (At the start of double-blind treatment period), up to 8 weeks
MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (such as apparent sadness, reported sadness, inner tension). MADRS corresponds to core symptoms of depression, and rated on a 7-point Likert scale from 0 (symptoms absent) to 6 (severe depression) with a total possible score range from 0 to 60. Higher scores indicate greater severity of symptoms. A negative change from Baseline indicates improvement.
次要结局
- MADRS Response at Week 8 (Last Observation Carried Forward (LOCF))(Week 8)
- MADRS Remission at Week 8 (LOCF)(Week 8)
- Change From Baseline in Hamilton Depression Scale (HAM-D17) Total Score to Week 8 (LOCF)(Baseline (At the start of double-blind treatment period), up to 8 weeks)
- Clinical Global Impressions-Improvement (CGI-I) Score at Week 8 (LOCF)(Week 8)
- Change From Baseline in Digit Symbol Substitution Test (DSST) Total Score to Week 8 (LOCF)(Baseline (At the start of double-blind treatment period), up to 8 weeks)
- Change From Baseline in Perceived Deficits Questionnaire (PDQ-5) Total Score to Week 8 (LOCF)(Baseline (At the start of double-blind treatment period), up to 8 weeks)
- Change From Baseline in Clinical Global Impressions-Severity (CGI-S) Score to Week 8 (LOCF)(Baseline (At the start of double-blind treatment period), up to 8 weeks)
- Change From Baseline in Sheehan Disability Scale (SDS) Total Score to Week 8 (LOCF)(Baseline (At the start of double-blind treatment period), up to 8 weeks)
研究者
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