A Randomized, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose Study Comparing the Efficacy and Safety of Lu AA21004 Versus Placebo 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
- 600
- 主要终点
- Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Week 6
研究概览
简要总结
The purpose of this study is to determine the efficacy and safety of once daily vortioxetine (Lu AA21004) in adults 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 vortioxetine.
The study enrolled 600 patients. Participants were randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which remained undisclosed to the patient and study doctor during the study (unless there was an urgent medical need):
- Vortioxetine 5 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-center trial was conducted in the United States. The overall time to participate in this study was approximately 94 days. Participants made 8 visits to the clinic, and were contacted by telephone 1 week, 2 weeks, and 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
- •Suffers from a major depressive episode (MDE) as the primary diagnosis according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria.
- •The reported duration of the current MDE is at least 3 months.
- •Has a Montgomery Åsberg Depression Rating Scale total score greater than or equal to
- •Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
排除标准
- •Has received any investigational compound less than 30 days before Screening or 5 half-lives prior to Screening, whichever is longer.
- •Has received Lu AA21004 in a previous clinical study.
- •Has 1 or more the following:
- •Any current psychiatric disorder other than major depressive disorder as defined in the DSM-IV-TR (as assessed by the Mini International Neuropsychiatric Interview)
- •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.
- •Presence or history of a clinically significant neurological disorder (including epilepsy).
- •Neurodegenerative disorder (Alzheimer disease, Parkinson disease, multiple sclerosis, Huntington disease, etc).
- •Any Axis II disorder that might compromise the study.
- •Is required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:
- •Narcotic analgesics
- •Nonsteroidal anti-inflammatory drugs
- •Macrolide antibiotics
- •Hormones (only thyroid hormone replacement, contraceptives [oral, patch], estrogen and progesterone replacement therapy are allowed in chronic use)
- •Hypoglycemic agents (chronic use is allowed)
- •Insulin (chronic use is allowed)
- •Systemic steroids
- •Quinidine
- •Antineoplastics
- •Antiobesity agents
- •Has a significant risk of suicide according to the investigator's opinion or has a score greater than or equal to 5 on item 10 (suicidal thoughts) of the Montgomery Åsberg Depression Rating Scale or has made a suicide attempt in the previous 6 months.
- •The current depressive symptoms are considered by the investigator to have been resistant to 2 adequate antidepressant treatments of at least 6 weeks duration each.
- •Has received electroconvulsive therapy within 6 months prior to Screening.
- •Is currently receiving formal cognitive or behavioral therapy, systematic psychotherapy, or plans to initiate such therapy during the study.
- •Has a clinically significant unstable illness, for example, hepatic impairment or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, rheumatologic, immunologic, infectious, skin and subcutaneous tissue disorders, or metabolic disturbance.
- •Has an alanine aminotransferase, aspartate aminotransferase or total bilirubin level greater than 1.5 times the upper limits of normal.
- •Has a serum creatinine greater than 1.5 times the upper limits of normal.
- •Has a previous history of cancer that had been in remission for less than 5 years prior to the first dose of study medication. This criterion does not include basal cell or Stage I squamous cell carcinoma of the skin.
- •Has clinically significant abnormal vital signs as determined by the investigator.
- •Has an abnormal electrocardiogram determined by the central reader and confirmed as clinically significant by the investigator.
- •Has 1 or more laboratory values outside the normal range, based on the blood or urine samples taken at the Screening Visit, that are considered by the investigator to be clinically significant.
- •Has a thyroid stimulating hormone value outside the normal range at Screening Visit that is determined to be clinically significant by the investigator.
- •Has a disease or takes medication that, in the opinion of the investigator, could interfere with the assessments of safety, tolerability, or efficacy.
- •Has previously enrolled in this study.
研究组 & 干预措施
Placebo
Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.
干预措施: Placebo (Drug)
Vortioxetine
Vortioxetine 5 mg, encapsulated tablet, orally, once daily for up to 6 weeks.
干预措施: Vortioxetine (Drug)
结局指标
主要结局
Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Week 6
时间窗: Baseline and Week 6
The 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 were from an Analysis of Covariance (ANCOVA) model with treatment and center as fixed factors and the baseline value as a covariate.
Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Other Weeks Assessed
时间窗: Baseline and Weeks 1, 2, 3, 4 and 5
The 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 ranges from 0 to 74 where a higher score indicates a greater depressive state. LS means were from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.
次要结局
- Percentage of Responders in HAM-D24 Total Score by Study Visit(Baseline and Weeks 1, 2, 3, 4, 5 and 6.)
- Percentage of Participants in MADRS Remission at Week 6(Week 6)
- Percentage of Participants With a Sustained Response in HAM-D24(Baseline to Week 6)
- Change From Baseline in Hamilton Anxiety Scale (HAM-A)(Baseline and Weeks 1, 2, 4 and 6.)
- Change From Baseline in Montgomery-Åsberg Depression Rating Scale - Self-assessment (MADRS-S)(Baseline and Weeks 1, 4 and 6.)
- Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score(Baseline and Weeks 1, 2, 3, 4, 5 and 6.)
- Clinical Global Impression Scale-Global Improvement Scale(Baseline and Weeks 1, 2, 3, 4, 5 and 6.)
- Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 6(Baseline and Week 6)
- Health Care Resource Utilization as Assessed by the Health Economic Assessment Questionnaire(Baseline and Week 6)
- Change From Baseline in Clinical Global Impression Scale-Severity of Illness(Baseline and Weeks 1, 2, 3, 4, 5 and 6.)
- Change From Baseline in 36-item Short-form Health Survey (SF-36) at Week 6(Baseline and Week 6)