NCT00849693已完成3 期
A Double-Blind, Efficacy and Safety Study of Duloxetine Versus Placebo in the Treatment of Children and Adolescents With Major Depressive Disorder
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
- 463
- 试验地点
- 1
- 主要终点
- Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 10 Endpoint
研究概览
简要总结
The purpose of this study is to assess whether duloxetine is superior to placebo in the treatment of children and adolescents with major depressive disorder (MDD)
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
- 7 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatient, diagnosed with major depressive disorder (MDD) as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) and supported by the Mini International Neuropsychiatric Interview for children and adolescents (MINI-KID).
- •Diagnosis of moderate or greater severity of MDD as determined by Children's Depression Rating Scale - Revised (CDRS-R) with a total score greater than or equal to 40 at screen, and randomization and a Clinical Global Impression of Severity (CGI-Severity) rating of greater than or equal to 4 at screen, and randomization.
- •Female patients must test negative for pregnancy during screening.
- •Judged to be reliable by the investigator to keep all appointments for clinical visits, tests, and procedures required by the protocol.
- •Has a degree of understanding such that they can communicate intelligently with the investigator and study coordinator.
- •Capable of swallowing study drug whole. It is anticipated the patients will need to swallow up to 6 capsules per day.
- •Patients must have venous access sufficient to allow blood sampling and are compliant with blood draws as per the protocol.
排除标准
- •Children of site personnel directly affiliated with this study and/or their immediate families.
- •Children of Lilly employees or employees of the designated clinical research organization (CRO) assisting with the conduct of the study.
- •Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
- •Have a current or previous diagnosis of bipolar disorder, psychotic depression, schizophrenia or other psychotic disorder, anorexia, bulimia, obsessive compulsive disorder, or pervasive development disorder, as judged by the investigator.
- •Have a history of DSM-IV-TR-defined substance abuse or dependence within the past year, excluding caffeine and nicotine.
- •Have a current primary DSM-IV-TR Axis I disorder other than MDD or a current secondary DSM-IV-TR Axis I disorder that requires any pharmacologic treatment
- •Have 1 or more first-degree relatives with diagnosed bipolar I disorder.
- •Have a significant suicide attempt within 1 year of screening or are currently at risk of suicide in the opinion of the investigator.
- •Have a weight less than 20 kilogram (kg) at screening.
- •Have a lack of response to 2 or more adequate treatment trials of antidepressants at a clinically appropriate dose for a minimum of 4 weeks for the same MDD episode.
- •Have initiated, stopped, or changed the type or intensity of psychotherapy within 6 weeks prior to screening.
- •Have a history of seizure disorder (other than febrile seizures).
- •Have a history of electroconvulsive therapy within 1 year of screening.
- •Have had treatment with a monoamine oxidase inhibitor (MAOI) within 14 days or fluoxetine within 30 days of randomization; or the potential need to use an MAOI during the study or within 5 weeks of discontinuation of study drug.
- •Have previously enrolled, completed, or withdrawn from this study or any other study investigating duloxetine or fluoxetine.
- •Have a positive urine drug screen for any substances of abuse or excluded medication.
- •Are taking any excluded medications that cannot be discontinued by screening.
- •Have known hypersensitivity to duloxetine, fluoxetine, or their inactive ingredients; or have frequent or severe allergic reactions to multiple medications.
- •Have uncontrolled narrow-angle glaucoma.
- •Have acute liver injury or severe cirrhosis.
- •Have a serious or unstable medical illness, psychological condition, or clinically significant laboratory or electrocardiogram (ECG) result that, in the opinion of the investigator, would compromise participation in the study or be likely to lead to hospitalization.
- •Have abnormal thyroid-stimulating hormone concentration.
- •Have initiated or discontinued hormone therapy within the previous 3 months.
- •Female patients who are either pregnant, nursing or have recently given birth.
- •Need to use thioridazine during the study or within 5 weeks after discontinuation of study drug or need to use pimozide during the study.
研究组 & 干预措施
Duloxetine 30 mg
Experimental
干预措施: duloxetine (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Fluoxetine
Active Comparator
干预措施: fluoxetine (Drug)
Duloxetine 60 mg
Experimental
干预措施: duloxetine (Drug)
结局指标
主要结局
Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 10 Endpoint
时间窗: Baseline, Week 10
CDRS-R Total score measure the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning. Total scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, and scores of 40 to 60 indicate moderate depression. Least Square (LS) means are adjusted for baseline, pooled investigator, age category, visit, treatment, treatment\*visit, age category\*visit and baseline\*visit.
次要结局
- Change From Week 10 in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 36 Endpoint(Week 10, Week 36)
- Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 10 Endpoint(Baseline, Week 10)
- Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Subscale Score at Week 10 Endpoint(Baseline, Week 10)
- Change From Week 10 in Children's Depression Rating Scale-Revised (CDRS-R) Subscale Score at Week 36 Endpoint(Week 10, Week 36)
- Change From Baseline in Clinical Global Impressions of Severity (CGI-Severity) Scale at Week 10 Endpoint(Baseline, Week 10)
- Change From Week 10 in Clinical Global Impressions of Severity (CGI-Severity) Scale at Week 36 Endpoint(Week 10, Week 36)
- Number of Participants With Suicidal Ideation or Suicidal Behavior Baseline Through Week 10(Baseline through Week 10)
- Number of Participants With Suicidal Ideation or Suicidal Behavior Week 10 Through Week 36(Week 10 through Week 36)
- Number of Participants With Potentially Clinically Significant Hepatic Laboratory Results Any Time Baseline Through Week 10(Baseline through Week 10)
- Number of Participants With Potentially Clinically Significant Hepatic Laboratory Results Any Time Week 10 Through Week 36(Week 10 through Week 36)
- Percentage of Participants With Potentially Clinically Significant (PCS) Changes in Systolic Blood Pressure (BP), Diastolic BP, Pulse, and Weight Any Time Baseline Through Week 10(Baseline through Week 10)
- Percentage of Participants With Potentially Clinically Significant (PCS) Changes in Systolic Blood Pressure (BP), Diastolic BP, Pulse, and Weight Any Time Week 10 Through Week 36(Week 10 through Week 36)
研究者
研究点 (1)
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