A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Fixed-Dose Study Comparing the Efficacy and Safety of Single Dose 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
- 304
- 主要终点
- Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Week 8
研究概览
简要总结
The purpose of this study is to determine the safety and efficacy of vortioxetine, once daily (QD), in treating Generalized Anxiety Disorder.
详细描述
The drug that was tested in this study is called Vortioxetine. Vortioxetine is being tested to treat anxiety in adults who have general anxiety disorder (GAD). This study looked at GAD relief in people who took vortioxetine.
The study enrolled 304 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 up to 13 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 —（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 the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR®) criteria.
- •Has a Hamilton Anxiety Scale total score greater than or equal to 20 at Screening and Baseline.
- •Has a Hamilton Anxiety Scale score greater than or equal to 2 on both Item 1 (anxious mood) and Item 2 (tension) at Screening and Baseline.
- •Has a Montgomery-Åsberg Depression Rating Scale total score less than or equal to 16 at Screening and Baseline.
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 subject 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 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.
- •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 greater than 1.5 times the upper limit of normal.
- •Has a serum creatinine of greater than 1.5 times 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 at Screening and is deemed clinically significant by the investigator.
- •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 5 mg
Vortioxetine 5 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 at Week 8
时间窗: Baseline to 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 a mixed model for repeated measurements (MMRM).
次要结局
- Change From Baseline in the Hospital Anxiety and Depression (HAD) Anxiety Subscale at Week 8(Baseline to Week 8)
- Clinical Global Impression Scale-Global Improvement at Week 8(Baseline to Week 8)
- Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8(Baseline to Week 8)
- Percentage of Responders in HAM-A Total Score at Week 8(Baseline and Week 8)
- Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Week 8 in Participants With Baseline HAM-A ≥25(Baseline to Week 8)
- Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Social Functioning Subscore at Week 8(Baseline to Week 8)
- Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed(Baseline to Weeks 1, 2, 4 and 6.)
- Change From Baseline in the Hospital Anxiety and Depression (HAD) Anxiety Subscale at Other Weeks Assessed(Baseline to Weeks 1 and 4)
- Clinical Global Impression Scale-Global Improvement at Other Weeks Assessed(Baseline to Weeks 1, 2, 4 and 6)
- Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Other Weeks Assessed(Baseline to Weeks 1, 2 and 4)
- Percentage of Responders in HAM-A Total Score at Other Weeks Assessed(Baseline and Weeks 1, 2, 4 and 6)
- Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed in Participants With Baseline HAM-A ≥25(Baseline to Weeks 1, 2, 4 and 6)
- Percentage of Participants in HAM-A Remission at Each Week Assessed(Weeks 1, 2, 4, 6 and 8)
- Change From Baseline in Clinical Global Impression Scale-Severity of Illness at Each Week Assessed(Baseline to Weeks 1, 2, 4, 6 and 8)
- Change From Baseline in the Hospital Anxiety and Depression (HAD) Depression Subscale at Each Week Assessed(Baseline to Weeks 1, 4 and 8)
- Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Social Functioning Subscore at Other Weeks Assessed(Baseline to Weeks 2 and 4)
- Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Physical Functioning Subscore at Each Week Assessed(Baseline to Weeks 2, 4 and 8)
- Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Physical Subscore at Each Week Assessed(Baseline to Weeks 2, 4 and 8)
- Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Bodily Pain Subscore at Each Week Assessed(Baseline to Weeks 2, 4 and 8)
- Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Subscore at Each Week Assessed(Baseline to Weeks 2, 4 and 8)
- Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Vitality Subscore at Each Week Assessed(Baseline to Weeks 2, 4 and 8)
- Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Emotional Subscore at Each Week Assessed(Baseline to Weeks 2, 4 and 8)
- Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Mental Health Subscore at Each Week Assessed(Baseline to Weeks 2, 4 and 8)
- Health Care Resource Utilization as Assessed by the Health Economic Assessment Questionnaire(Baseline and Week 8)