A Phase 3, Open-label, Long-Term Study to Evaluate the Safety of LY110140 Once Daily Dosing for 52-week in Japanese Patients With Major Depressive Disorder
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Events (AEs) or Serious AEs (SAEs)
研究概览
简要总结
This study will evaluate the safety and effectiveness of fluoxetine flexible dosing in the treatment of MDD in adult Japanese participants.
Participants who complete the short-term treatment phase of Study B1Y-JE-HCLV (NCT#: NCT01808612) will be allowed to enroll in this study, and receive fluoxetine treatment for an additional 52 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have completed Study B1Y-JE-HCLV (NCT#:NCT01808612)
- •Agree to abstain from sexual activity or to use a reliable method of birth control
排除标准
- •Significant suicidal risk
- •Have a current or previous diagnosis of bipolar disorder, psychotic depression, schizophrenia or other psychotic disorder, anorexia, bulimia, obsessive compulsive disorder, or post-traumatic stress disorder
- •Have a history of substance abuse or dependence within the past 6 months, excluding caffeine and nicotine
- •Need to use thioridazine or pimozide during the study
- •Have a positive urine drug screen for drugs with abuse potential
- •Female participants who are either pregnant, nursing, or have recently given birth, or male participants who are planning for their partners to be or become pregnant
- •Have frequent or severe allergic reactions to multiple medications
- •Have a serious or unstable medical illness or condition, or psychological condition
- •Participants deemed ineligible by the investigator or sub-investigator for other reasons
研究组 & 干预措施
Fluoxetine
Flexible dosing of 20 to 40 milligrams (mg) administered orally, once daily, for approximately 52 weeks
干预措施: Fluoxetine (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (AEs) or Serious AEs (SAEs)
时间窗: Baseline through Week 52.
Number of Participants With Suicidal Behaviors and Ideations Collected by Columbia - Suicide Severity Rating Scale (C-SSRS)
时间窗: Baseline through Week 52
C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior is defined as a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation is defined as a "yes" answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation.
次要结局
- Mean Change From Baseline to Week 52 on the Clinical Global Impression of Severity (CGI-S) Scale(Baseline, Week 52)
- Change From Baseline to Week 52 in Sheehan Disability Scale (SDS) Total Score and Subscale Scores(Baseline up to 52 weeks)
- Mean Change From Baseline to Week 52 on the 21-Item Hamilton Depression Rating Scale (HAMD21) Total Score(Baseline, Week 52)
- Percentage of Participants Achieving a Response at Week 52(Baseline, up to Week 52)
- Percentage of Participants Achieving a Remission at Week 52(up to Week 52)
- Mean Change From Baseline to Week 52 on the HAMD21 Subscale Scores(Baseline, Week 52)