A Multi-region, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Evaluating SEP-4199 Controlled Release (CR) for the Treatment of Major Depressive Episode Associated With Bipolar I Disorder (Bipolar I Depression)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 83
- 试验地点
- 88
- 主要终点
- Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 6
研究概览
简要总结
A clinical trial to study the efficacy and safety of an investigational drug in people with major depressive episodes associated with with Bipolar I disorder (bipolar I depression) Participants in the study will either receive the drug being studied or a placebo. The study will be conducted in approximately 90 sites in North America, Europe, Latin America and Japan. It will be have both male and female participants ages 18-65. Participation in the study will be approximately 10 weeks.
详细描述
This study is a randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy, safety, and tolerability of treatment with SEP-4199 CR at fixed doses of 200 mg/day or 400 mg/day compared with placebo for the treatment of major depressive episode associated with bipolar I disorder (bipolar I depression). The study is projected to randomize approximately 522 subjects inNorth America, Japan, Europe and Latin America, to SEP-4199 CR 200 mg/day, SEP-4199 CR 400 mg/day, and placebo treatment groups in a 1:1:1 ratio
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double Blind
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria (not all inclusive):
- •Subject provides written informed consent and is willing and able to comply with the protocol in the opinion of the Investigator.
- •Subject is 18 to 65 years of age, inclusive, at the time of informed consent.
- •Subject meets DSM-5 criteria, based on the SCID-5-CT, for bipolar I disorder, current episode depressed with or without rapid cycling disease course (≥ 4 episodes of mood disturbance but < 8 episodes in the previous 12 months) with or without psychotic features.
- •Subject's current major depressive episode is ≥ 4 weeks and less than 12 months in duration at Screening.
- •Subject has a MADRS total score ≥ 22 at both Screening and Baseline.
- •Subject has a CGI-BP-S depression score ≥ 4 at both Screening and Baseline.
- •Subject has a YMRS total score ≤ 12 at both Screening and Baseline.
- •Subject is in good physical health, based on medical history, physical examination, neurological examination, vital signs, ECGs, and results of clinical laboratory tests (hematology, chemistry, and urinalysis).
排除标准
- •Exclusion Criteria (not all inclusive):
- •Subject currently has any DSM-5 defined psychiatric diagnosis other than bipolar I disorder that was the primary focus of treatment, or is currently being treated with concomitant medication
- •Subject has a lifetime history of, or symptoms consistent with, schizophrenia, schizoaffective disorder, or a major psychiatric diagnosis other than bipolar I disorder that is judged to pose risk to the study scientific objectives
- •Subject has a history of non-response to an adequate (6-week) trial of 3 or more antidepressants (with or without mood stabilizers) during the current major depressive episode.
- •Subject has any clinically significant unstable medical condition or any clinically significant chronic disease that would pose a risk to the subject or that might confound the results of the study.
研究组 & 干预措施
SEP-4199 CR 200 mg
SEP-4199 CR 200 mg/day
干预措施: SEP-4199 CR 200 mg (Drug)
SEP-4199 CR 400 mg
SEP-4199 CR 400 mg/day
干预措施: SEP-4199 CR 400 mg (Drug)
Placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 6
时间窗: 6 Weeks
Montgomery-Asberg Depression Rating Scale (MADRS) is a clinician-rated assessment of the subject's level of depression. The measure contains 10 items that measure apparent and reported sadness, inner tension, reduced sleep and appetite, difficulty concentrating, lassitude, inability to feel, and pessimistic and suicidal thoughts, each ranging from 0 to 6. The MADRS total score ranges from 0 to 60, with higher scores indicating increased depressive symptoms
次要结局
- Change From Baseline in Global Severity Assessed by the Clinical Global Impressions Severity: Bipolar Version (CGI-BP-S) Score (Depression) at Week 6(6 Weeks)