A Randomized, Double-blind, Parallel-Group, Placebo-Controlled, Fixed-Dose Study Comparing the Efficacy and Safety of 3 Doses of Lu AA21004 in Acute Treatment of Adults With Major Depressive Disorder
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 560
- 主要终点
- Change From Baseline in the 24-item Hamilton Depression Scale Total Score At Week 8
研究概览
简要总结
The purpose of this study is to determine the effectiveness and safety of vortioxetine, once daily (QD), in patients with Major Depressive Disorder.
详细描述
The drug that was tested in this study is called vortioxetine. Vortioxetine is being tested to treat depression in adults who have major depressive disorder (MDD). This study looked at MDD relief in people who took varying dosages of vortioxetine.
The study enrolled 560 patients. Participants were randomly assigned (by chance, like flipping a coin) to one of the four treatment groups-which remained undisclosed to the patient and study doctor during the study (unless there was an urgent medical need):
- Vortioxetine 1 mg
- Vortioxetine 5 mg
- Vortioxetine 10 mg
- Placebo (dummy inactive pill) - this was a capsule that looked like the study drug but had no active ingredient.
All participants were asked to take one capsule at the same time each day throughout the study.
This multi-centre trial was conducted in Europe, Asia, Australia, and South Africa. The overall time to participate in this study was up to 14 weeks. Participants made 7 visits to the clinic, and were contacted by telephone 4 weeks after the last dose of study drug for a follow-up assessment.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has a primary diagnosis of major depressive episode according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria.
- •The reported duration of the current major depressive episode is at least 3 months.
- •Has a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≥
- •A male or a female of childbearing potential who is sexually active agrees to use adequate contraception from Screening throughout the duration of the study and for 1 month after the last dose of study medication.
排除标准
- •Has 1 or more the following:
- •Any current psychiatric disorder other than major depressive disorder as defined in the DSM-IV-TR.
- •Current or past history of: manic or hypomanic episode, schizophrenia or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR.
- •Any substance disorder (except nicotine and caffeine) within the previous 6 months as defined in the DSM-IV-TR. (must have negative urine drug screen prior to Baseline).
- •Presence or history of a clinically significant neurological disorder (including epilepsy).
- •Neurodegenerative disorder (Alzheimer disease, Parkinson disease, multiple sclerosis, Huntington disease, etc).
- •Has a significant risk of suicide according to the investigator's opinion or has a score ≥5 on item 10 (suicidal thoughts) of the Montgomery Åsberg Depression Rating Scale, or has made a suicide attempt in the previous 6 months.
- •Currently receiving formal cognitive or behavioral therapy, systematic psychotherapy, or plans to initiate such therapy during the study.
- •Has a clinically significant unstable illness.
- •Has previously failed to respond to adequate treatment with selective serotonin reuptake inhibitors and/or serotonin-norepinephrine reuptake inhibitors.
- •Has received electroconvulsive therapy within 6 months prior to Screening.
- •Has an alanine aminotransferase, aspartate aminotransferase, or total bilirubin level > 1.5 times the upper limit of normal.
- •Has a serum creatinine of > 1.5 × upper limit of normal.
- •Has a previous history of cancer that had been in remission for less than 5 years.
- •Has thyroid stimulating hormone value outside the normal range.
- •Has an abnormal electrocardiogram.
研究组 & 干预措施
Vortioxetine 1 mg
Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
干预措施: Vortioxetine (Drug)
Vortioxetine 5 mg
Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
干预措施: Vortioxetine (Drug)
Vortioxetine 10 mg
Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
干预措施: Vortioxetine (Drug)
Placebo
Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in the 24-item Hamilton Depression Scale Total Score At Week 8
时间窗: Baseline to Week 8
The 24-item Hamilton Depression Scale (HAM-D24) is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score range is from 0 to 74 where a higher score indicates a greater depressive state. Least squares (LS) means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.
次要结局
- Percentage of Responders in HAM-D24 Total Score at Week 8(Baseline and Week 8)
- Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Other Weeks Assessed(Baseline and Weeks 1, 2, 4 and 6)
- Change From Baseline in HAM-D24 Total Score at Week 8 in Participants With Baseline HAM-A Score ≥20(Baseline to Week 8)
- Percentage of Participants in MADRS Remission at Week 8(Week 8)
- Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Other Weeks Assessed(Baseline and Weeks 1, 2 and 6)
- Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Each Week Assessed(Baseline and Weeks 1, 2, 4, 6, and 8)
- Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Physical Subscore at All Weeks Assessed(Baseline and Weeks 2, 4 and 8)
- Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Bodily Pain Subscore at All Weeks Assessed(Baseline and Weeks 2, 4 and 8)
- Change From Baseline in Hospital Anxiety and Depression (HAD) Scales at Each Week Assessed(Baseline and Weeks 1, 4, and 8)
- Clinical Global Impression Scale-Global Improvement at Week 8(Baseline to Week 8)
- Clinical Global Impression Scale-Global Improvement at Other Weeks Assessed(Baseline and Weeks 1, 2, 4 and 6)
- Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Subscore at All Weeks Assessed(Baseline and Weeks 2, 4 and 8)
- Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Emotional Subscore at All Weeks Assessed(Baseline and Weeks 2, 4 and 8)
- Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8(Baseline to Week 8)
- Percentage of Responders in HAM-D24 Total Score at Other Weeks Assessed(Baseline and Weeks 1, 2, 4 and 6)
- Change From Baseline in HAM-D24 Total Score at Other Weeks Assessed in Participants With a Baseline HAM-A Score ≥20(Baseline and Weeks 1, 2, 4 and 6)
- Percentage of Participants in MADRS Remission at Other Weeks Assessed(Weeks 1, 2, 4 and 6)
- Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Physical Functioning Subscore at All Weeks Assessed(Baseline and Weeks 2, 4 and 8)
- Healthcare Resource Utilization as Assessed by the Health Economic Assessment Questionnaire.(Baseline and Week 8)
- Percentage of Participants With a Sustained Response in HAM-D24 Total Score(From Baseline through Week 8)
- Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score at Each Week(Baseline and Weeks 1, 2, 4, 6, and 8)
- Change From Baseline in Clinical Global Impression Scale-Severity of Illness at Each Week Assessed(Baseline and Weeks 1, 2, 4, 6, and 8)
- Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Vitality Subscore at All Weeks Assessed(Baseline and Weeks 2, 4 and 8)
- Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Social Functioning Subscore at Other Weeks Assessed(Baseline and Weeks 2 and 4)
- Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Mental Health Subscore at All Weeks Assessed(Baseline and Weeks 2, 4 and 8)