A Phase IV, Double-Blind, Placebo-Controlled, Randomized, Flexible Dose Study of the Safety and Efficacy of EMSAM in Adolescents With Major Depression
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 308
- 试验地点
- 20
- 主要终点
- CDRS-R Total Score (Child) (mITT w/LOCF Population) Week 12
研究概览
简要总结
The primary purpose of your participation in this study is to help answer the following research question: Whether 12-week administration of EMSAM (selegiline transdermal system) is safe and effective for the treatment of adolescents (aged 12 through 17 years) with Major Depressive Disorder (MDD).
详细描述
• Assess the safety and efficacy of EMSAM (selegiline transdermal system) versus placebo in adolescents (aged 12 through 17 years) who meet criteria for Major Depressive Disorder (MDD) without psychotic features, single or recurrent
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
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male / Female outpatients 12 to 17 years of age diagnosed with Major Depressive Disorder (MDD). (Must have a Children's Depression Rating Scale-Revised [CDRS-R] with a total score of at least 45 at screening.)
- •Female patients must test negative on a pregnancy at visit
- •Weight and height must be greater than the 10th percentile according to age and height,
- •Assent and consent must be given.
排除标准
- •Have a serious or unstable medical illness, psychological condition, clinically significant laboratory or ECG result, hypersensitivity to selegiline, or any other condition that in the opinion of the investigator would compromise participation in the study or be likely to lead to hospitalization during the course of the study.
- •Have a current or previous diagnosis of bipolar disorder, psychotic depression, schizophrenia or other psychotic disorder, anorexia, bulimia, obsessive compulsive disorder, pervasive development disorder or borderline personality disorder, as determined by the investigator.
- •Have a risk of suicide
- •Female patients who are either pregnant, nursing or have recently given birth.
- •Use of any protocol prohibited medications or substances.
研究组 & 干预措施
EMSAM
Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg
干预措施: Selegiline Transdermal System (Drug)
Placebo
Placebo Selegiline Transdermal System 6, 9 or 12
干预措施: Placebo (Drug)
结局指标
主要结局
CDRS-R Total Score (Child) (mITT w/LOCF Population) Week 12
时间窗: baseline and 12 Weeks
A summary of the primary efficacy outcome measure, Children's Depression Rating Scale (CDRS-R) Total Score, as reported by the Child, at Week 12 (EOS), by treatment assigned, is shown for the modified intent-to-treat (mITT) population, with the last observation carried forward (LOCF) in time. CDRS-R total raw scores range from 17(minimum) 113(maximum). A lower score indicates a lower likelihood of a depressive disorder, a higher score indicates a higher likelihood of a depressive disorder. Two subscales are summed to calculate a total score: Evaluated Symptom Area and Ratings of Observed Nonverbal Behavior.
次要结局
- CGI-S - Week 12 (mITT w/LOCF Population)(Baseline and 12 Weeks)
- CGI-C - Week 12 (mITT w/LOCF Population)(12 Weeks)
- CGI-C Percent Responders (mITT w/LOCF Population)(12 Weeks)
- CDRS-R Total Score (Parent/Other) Week 12 (mITT w/LOCF Population)(Baseline and 12 Weeks)
- CDRS-R Total Score (Best Description) Week 12 (mITT w/LOCF Population)(12 Weeks)
- Physical Examination (Screening vs. EOS)(12 Weeks)
- Urinalysis (Change From Baseline)(12 Weeks)
- Vital Signs-Heart Rate (Change From Baseline)(12 Weeks)
- Vital Signs-Blood Pressure (Change From Baseline)(12 Weeks)
- CDRS-R Total Score (Child) Week 12 (mITT w/OC Population)(12 Weeks)
- CDRS-R Total Score (Parent/Other) Week 12 (mITT w/OC Population)(12 Weeks)
- CDRS-R Total Score (Best Description) Week 12 (mITT w/OC Population)(12 Weeks)
- 12 Lead ECG (Change From Baseline)(12 Weeks)
- 12 Lead ECG (Change From Baseline)Ventricular Heart Rate(12 Weeks)
- Hematology - White Blood Cell (WBC) (Change From Baseline)(12 Weeks)
- Hematology - Hematocrit (Change From Baseline)(12 Weeks)
- Hematology - Hemoglobin (Change From Baseline)(12 Weeks)
- Hematology - Red Blood Cell (Change From Baseline)(12 Weeks)