NCT01421134已完成3 期
A Randomized, 6-Week, Double-Blind, Placebo-Controlled, Flexible-Dose, Parallel-Group Study of Lurasidone for the Treatment of Major Depressive Disorder With Mixed Features
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 211
- 试验地点
- 42
- 主要终点
- Mean Change From Baseline to the 6-week Study Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Scores
研究概览
简要总结
Lurasidone HCl is a compound that is a candidate for the treatment of major depressive with mixed features.This clinical study is designed to test how well Lurasidone works to treat major depressive disorder with mixed features.
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)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 75 years of age, inclusive.
- •Subject has MDD (diagnosed by DSM-IV-TR, and confirmed by the Structured - Clinical Interview for DSM-IV Disorders - Clinical Trial version [SCID-CT]).
- •Subject is currently experiencing a major depressive episode (diagnosed by DSM IV TR; at least 2 weeks in duration) AND two or three of the following manic symptoms occurring on most days over at least the last 2 weeks (confirmed by the SCID-CT modified for Study D1050304):
- •Elevated, expansive mood
- •Inflated self-esteem or grandiosity
- •More talkative than usual or pressure to keep talking
- •Flight of ideas or subjective experience that thoughts are racing
- •Increase in energy or goal-directed activity (either socially, at work or school, or sexually)
- •Increased or excessive involvement in activities that have a high potential for painful consequences (e.g., engaging in unrestrained buying sprees, sexual indiscretions, or foolish business investments)
- •Decreased need for sleep (feeling rested despite sleeping less than usual; to be contrasted from insomnia)
排除标准
- •Subject has Axis I or Axis II diagnosis other than MDD that has been the primary focus of treatment within the 3 months prior to screening.
- •Subject answers "yes" to "Suicidal Ideation" Item 4 or 5 on the C-SSRS (at time of evaluation) at screening or baseline visit.
- •Subject has attempted suicide within the past 3 months.
- •Subject has a lifetime history of any bipolar I manic or mixed manic episode.
- •Subject has any abnormal laboratory parameter at screening that indicates a clinically significant medical condition as determined by the Investigator.
研究组 & 干预措施
Lurasidone
Experimental
Lurasidone 20, 40 or 60 mg
干预措施: Lurasidone (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Mean Change From Baseline to the 6-week Study Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Scores
时间窗: Baseline to Week 6
The MADRS consists of 10 items, each rated on a Likert scale, from 0="Normal" to 6="Most Severe". The MADRS total score is calculated as the sum of the 10 items. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity.
次要结局
- Mean Change From Baseline to the 6-week Study Endpoint in the Clinical Global Impression-Severity of Illness (CGI-S) Score(Baseline to Week 6)
- Mean Change From Baseline to Week 6 in the Young Mania Rating Scale (YMRS) Total Score(Baseline to Week 6)
- Mean Change From Baseline to Week 6 in the Hamilton Rating Scale for Anxiety(HAM-A) Total Score(Baseline to Week 6)
- Percentage of Subjects Who Achieve a Remission, Defined as a Montgomery-Asberg Depression Rating Scale (MADRS) Total Score of ≤ 12 at Week 6 (LOCF)(Baseline to Week 6)
- Percentage of Subjects Who Achieve a Response, Defined as ≥ 50% Reduction From Baseline on the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 6 (LOCF).(Baseline to Week 6)
- Mean Change From Baseline to Week 6 in the Sheehan Disability Scale (SDS) Total Score(Baseline to Week 6)
研究者
研究点 (42)
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