A Phase 3, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Trial to Compare the Efficacy and Safety of Fixed Doses of SEP-363856 to Placebo in the Treatment of Adults With Generalized Anxiety Disorder
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 576
- 试验地点
- 3
- 主要终点
- Change From Baseline at Week 8 in Hamilton Anxiety Rating Scale (HAM-A) Total Score
研究概览
简要总结
This is a global, phase 3, randomized, double-blind, parallel-group, 3-arm, placebo-controlled, multicenter study designed to compare the efficacy, safety, and tolerability of fixed doses of SEP-363856 (50 and 75 milligrams per day [mg/day]) to placebo in adults at least 18 years of age with generalized anxiety disorder (GAD) over 8 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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Male or female participants at least 18 years of age at the time of informed consent
- •Primary diagnosis of Generalized Anxiety Disorder (GAD) per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), confirmed by Mini-International Neuropsychiatric Interview (MINI) and clinical psychiatric evaluation
- •Body Mass Index (BMI) between 18 and 40 kilograms per square meter (kg/m^2) (inclusive)
- •Participant is willing and able to comply with study procedures and visit schedule
- •Medically stable as determined by medical history, physical exam, vital signs, and laboratory tests
- •Willing and able to discontinue prohibited medications/therapies per protocol
- •i) Females of childbearing potential: negative pregnancy test and agreement to use acceptable contraception ii) Males: agreement to follow protocol-defined contraception and reproductive restrictions
- •Participant is willing and able to safely discontinue all prohibited medications/therapies/herbal supplements in accordance with the protocol-required washouts prior to baseline/Day 1 and during the trial period.
排除标准
- •Current DSM-5 diagnosis of major depressive episode, post traumatic stress disorder (PTSD), or any psychiatric disorder other than GAD that was the primary focus of treatment within 12 months prior to screening
- •Substance use disorder (excluding nicotine/caffeine) within 12 months prior to screening
- •Lifetime history of certain psychiatric disorders (e.g., schizophrenia spectrum disorders, bipolar disorder, obsessive-compulsive disorder, borderline or antisocial personality disorder)
- •Significant suicide risk (e.g., recent suicidal behavior/ideation per Columbia-Suicide Severity Rating Scale [C-SSRS] or MADRS)
- •Use of prohibited medications/therapies within protocol-defined timeframes (e.g., certain antipsychotics, mood stabilizers, benzodiazepines, investigational treatments)
- •Prior exposure to restricted treatments
- •Pregnant or breastfeeding females
- •Participation in another investigational study within 180 days (or more than [>] 1 trial in last year)
- •Known history of human immunodeficiency virus seropositivity, hepatitis B or C
研究组 & 干预措施
SEP-363856 50 mg
Participants will receive 50 milligrams (mg) SEP-363856 tablet, orally, once a day (QD) from Days 1 to 56.
干预措施: SEP-363856 (Drug)
Placebo
Participants will receive SEP-363856-matching placebo tablet, orally, QD from Days 1 to 56.
干预措施: Placebo (Other)
SEP-363856 75 mg
Participants will receive 50 mg SEP-363856 tablet, orally, QD, from Days 1 to 3 and then 75 mg tablet from Days 4 to 56.
干预措施: SEP-363856 (Drug)
结局指标
主要结局
Change From Baseline at Week 8 in Hamilton Anxiety Rating Scale (HAM-A) Total Score
时间窗: Baseline, Week 8
The HAM-A is a clinician-administered rating scale developed to quantify the severity of anxiety symptomatology. It consists of 14 items, each defined by a series of symptoms. Each item is scored on a 5-point Likert-type scale ranging from 0 (absent) to 4 (very severe). The total score ranges from 0 to 56, with higher scores indicating greater severity.
次要结局
- Change From Baseline at Week 8 in Clinical Global Impression-Severity (CGI-S) Score(Baseline, Week 8)
- Proportion of Participants Achieving HAM-A Response Criterion at Week 8 (Greater Than or Equal to [≥] 50 Percent [%] Improvement From Baseline in HAM-A Total Score)(Baseline, Week 8)