An 8 Week Randomized Double Blind Placebo Controlled Multi-site Study Assessing Efficacy and Safety of MYDAYIS® (D-amphetamine / L-amphetamine) for Bipolar Depression
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Change in Montgomery-Asberg Depression Rating Scale (MADRS) score
研究概览
简要总结
This protocol is a Phase 2 multi-site study which aims to evaluate the safety and effectiveness of MYDAYIS® as adjunctive therapy for adults with bipolar depression. Results from this study WILL NOT be used to contribute to an approval of MYDAYIS ® for this indication.
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, Care Provider, Investigator)
盲法说明
Study subjects will be randomized to receive MYDAYIS® or placebo on a 1:1 ratio according to computer-generated coding. Each site will have its own randomization list. Allocation concealment will be achieved by having the research pharmacy perform the randomization, package the study medication, and maintain the integrity of the blinded information throughout the study.
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Mydayis - Active
MYDAYIS®, Oral administration, dose regimen for Double blind phase and open label phase.
12.5 mg x 7 days. 25 mg x 7 days 37.5 mg x 14 days 50 mg daily x 28 days
干预措施: Mydayis Extended-Release Capsule (Drug)
Placebo
Matching placebo, Oral administration, dose regimen for Double blind phase and open label phase.
12.5 mg x 7 days. 25 mg x 7 days 37.5 mg x 14 days 50 mg daily x 28 days
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Montgomery-Asberg Depression Rating Scale (MADRS) score
时间窗: Baseline to week 8 visit 10
Reduction in Montgomery-Asberg Depression Rating Scale (MADRS) score (Range: 0-60) between Baseline and Week 8 visit 10
次要结局
- Remission(Baseline to Week 8 visit 10)
- Change in Morningness-Eveningness Questionnaire (MEQ) score(Baseline to Week 8 visit 10)
- Change in Rapid Eating and Activity Assessment for Patients (REAP) score(Baseline to Week 8 visit 10)
- Change in Digit Symbol Substitution Test (DSST) score(Baseline to Week 8 visit 10)
- Change in Quick Inventory for Depressive Symptomatology (QIDS-C and QIDS-SR) score(Baseline to Week 8 visit 10)
- Response(Baseline to Week 8 visit 10)
- Change in Young Mania Rating Scale (YMRS) score(Baseline to Week 8 visit 10)
- Change in Epworth Sleepiness Scale (ESS) score(Baseline to Week 8 visit 10)
- Change in General Anxiety Disorder 7-item scale score(Baseline to Week 8 visit 10)
- Change in Fatigue Severity Scale (FSS) score(Baseline to Week 8 visit 10)
- Change in Clinical Global Impression for Bipolar Disorder (CGI-BP) score(Baseline to Week 8 visit 10)
- Change in Binge Eating Scale (BES) score(Baseline to Week 8 visit 10)