A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Fixed-Dose Study Comparing the Efficacy and Safety of 2 Doses of Lu AA21004 in Acute Treatment of Adults With Generalized Anxiety Disorder
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 457
- 主要终点
- Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of 2.5 mg and 10 mg vortioxetine, once daily (QD), in adults with generalized anxiety disorder.
详细描述
Participants in this study will be randomly assigned to receive either 2.5 mg or 10 mg of vortioxetine or a placebo once daily for an eight week treatment period.
Participants will be seen weekly during the first 2 weeks of treatment, and then every 2 weeks up to the end of the 8-week treatment period. Total commitment time is up to 12 weeks.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has a primary diagnosis of Generalized Anxiety Disorder according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR®) criteria (classification code 300.02).
- •Has a Hamilton Anxiety Scale total score ≥
- •Has a Hamilton Anxiety Scale score ≥ 2 on both item 1 (anxious mood) and item 2 (tension).
- •Has a Montgomery-Åsberg Depression Rating Scale total score ≤16.
排除标准
- •Has 1 or more of the following:
- •Any current psychiatric disorder other than Generalized Anxiety Disorder as defined in the DSM-IV-TR (as assessed by the Mini International Neuropsychiatric Interview [MINI]).
- •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 and participant must have a 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.).
- •Any Axis II disorder that might compromise the study.
- •Is taking excluded medications.
- •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.
- •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.
- •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.
- •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 × the 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
Placebo
Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
干预措施: Placebo (Drug)
Vortioxetine 2.5 mg
Vortioxetine 2.5 mg encapsulated tablets, orally, once daily for up to 8 weeks.
干预措施: Vortioxetine (Drug)
Vortioxetine 10 mg
Vortioxetine 10 mg encapsulated tablets, orally, once daily for up to 8 weeks.
干预措施: Vortioxetine (Drug)
结局指标
主要结局
Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score
时间窗: Baseline and Week 8
The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. 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.
次要结局
- Percentage of Participants in HAM-A Remission at Week 8(Week 8)
- Change From Baseline in Hospital Anxiety and Depression (HAD) Scales(Baseline and Weeks 1, 4 and 8.)
- Change From Baseline in Sheehan Disability Scale (SDS) at Week 8(Baseline and Week 8)
- Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed(Baseline and Weeks 1, 2, 4 and 6)
- Percentage of Responders in HAM-A Total Score at Week 8(Baseline and Week 8)
- Clinical Global Impression Scale-Global Improvement (CGI-I) at Each Week Assessed(Baseline and Weeks 1, 2, 4, 6 and 8.)
- Change From Baseline in Clinical Global Impression Scale-Severity of Illness (CGI-S)(Baseline and Weeks 1, 2, 4, 6 and 8.)
- Change From Baseline in 36-item Short-form Health Survey (SF-36)(Baseline and Week 8)
- Health Care Resource Utilization Assessed by the Health Economic Assessment Questionnaire(Baseline and Week 8)