NCT00960986已完成4 期
A Phase 4 Comparison of Duloxetine Dosing Strategies in the Treatment of Korean Patients With Major Depressive Disorder
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 249
- 试验地点
- 1
- 主要终点
- Mean Maximum Nausea Severity, Association for Methodology and Documentation in Psychiatry (AMDP-5) Adverse Event (AE) Scale Item 112 (Nausea)
研究概览
简要总结
The purpose of this study is to assess nausea severity in response to four different drug dosing strategies of Duloxetine (30 mg with food, 60 mg with food, 30 mg without food, and 60 mg without food) in Korean patients 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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For females of child-bearing potential test negative for pregnancy at the time of enrollment based on a urine pregnancy test and agree to use a reliable method of birth control during the study and for 1 month following the last dose of study drug.
- •17-item Hamilton Depression Rating Scale (HAMD-17) total score >15 at Screening and Randomization
- •Have signed the informed consent document (ICD)
- •Have a level of understanding sufficient to provide informed consent and to communicate with the investigators and site personnel
- •Are judged to be reliable and agree to keep all appointments for clinic visits, tests, and procedures required by the protocol
- •Patients must meet Diagnostic and Statistical Manual of Mental Disorders-fourth edition-text revision (DSM-IV-TR) criteria for Major Depressive Disorder (MDD). The Mini International Neuropsychiatric Interview (MINI) will be used to establish the diagnosis and exclude other psychiatric illnesses.
排除标准
- •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 any current primary Axis I disorder other than MDD
- •Have any previous diagnosis of bipolar disorder, schizophrenia, or other psychotic disorders
- •Lack of response of the current episode of major depression to two or more adequate courses of antidepressant therapy at clinically appropriate dose for a minimum of 4 weeks or, in the judgment of the investigator, the patient meets criteria for treatment-resistant depression
- •Have a history of a lack of response, at any time, to an adequate trial of duloxetine (defined as treatment with at least 60 mg/day of duloxetine for a minimum of 4 weeks)
- •Presence of an Axis II disorder that, in the judgment of the investigator, would interfere with study compliance
- •DSM-IV-TR-defined history of substance abuse or dependence within the past 6 months, excluding nicotine and caffeine
- •Patients judged to be at serious suicidal risk in the opinion of the investigator and/or score ≥3 on Item 3 (suicide) of the HAMD-17
- •Serious medical illness or clinically significant laboratory abnormalities that, in the judgment of the investigator, are likely to require intervention/hospitalization/excluded medication during the course of the study Note: Patients with acute liver injury (such as hepatitis) or severe (Child-Pugh Class C) cirrhosis will be excluded
- •Have an acute or chronic medical illness with the main symptoms of nausea or gastrointestinal discomfort or taking any medication known to have major gastric effects that would interfere with nausea ratings.
- •Electroconvulsive therapy (ECT) or Transcranial Magnetic Stimulation (TMS) within the past year
- •Taking any excluded medications within 7 days prior to Randomization.
- •Treatment with a monoamine oxidase inhibitor (MAOI) within 14 days prior to Randomization or potential need to use a MAOI within 5 days after discontinuation of study drug.
- •Treatment with fluoxetine within 30 days prior to Randomization.
- •Frequent and/or severe allergic reactions with multiple medications or known hypersensitivity to duloxetine.
- •Abnormal thyroid stimulating hormone (TSH) concentration. Note: Participants diagnosed with hyperthyroidism or hypothyroidism who were treated with a stable dose of thyroid supplement for at least the past 3 months, have medically appropriate TSH concentration, and are clinically euthyroid, are allowed to enroll in this study.
研究组 & 干预措施
Duloxetine 60 mg with food
Experimental
Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
干预措施: Duloxetine hydrochloride (Drug)
Duloxetine 60 mg without food
Experimental
Duloxetine 60 mg capsule po QD without food for 8 weeks
干预措施: Duloxetine hydrochloride (Drug)
Duloxetine 30 mg with food
Experimental
Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
干预措施: Duloxetine hydrochloride (Drug)
Duloxetine 30 mg without food
Experimental
Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
干预措施: Duloxetine hydrochloride (Drug)
结局指标
主要结局
Mean Maximum Nausea Severity, Association for Methodology and Documentation in Psychiatry (AMDP-5) Adverse Event (AE) Scale Item 112 (Nausea)
时间窗: 1 week and 8 weeks
AMDP-5 AE scale Item 112 (nausea) measured nausea severity during treatment (Week 0-8). The scores ranged from 0-3: 0=Not present; 1=Mild; 2=Moderate; 3=Severe.
次要结局
- Mean Change From Baseline to 1-Week and 8-Week Endpoints in 17-Item Hamilton Depression Rating Scale (HAMD-17) Retardation/Somatization Subscale(Baseline, 1 week, 8 weeks)
- Mean Change From Baseline to 1-Week and 8-Week Endpoints in Association for Methodology and Documentation in Psychiatry (AMDP-5) Measure: Common Adverse Events (AEs) Score(Baseline, 1 week, 8 weeks)
- Mean Change From Baseline to 8-Week Endpoint in Association for Methodology and Documentation in Psychiatry (AMDP-5) Adverse Event (AE) Scale Item 112 (Nausea)(Baseline, 8 weeks)
- Mean Change From Baseline to 1-Week and 8-Week Endpoints in 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score(Baseline, 1 week, 8 weeks)
- Mean Change From Baseline to 1-Week and 8-Week Endpoints in 17-Item Hamilton Depression Rating Scale (HAMD-17) Maier Subscale(Baseline, 1 week, 8 weeks)
- Mean Change From Baseline to 1-Week and 8-Week Endpoints in 17-Item Hamilton Depression Rating Scale (HAMD-17) Core Mood Subscale(Baseline, 1 week, 8 weeks)
- Mean Change From Baseline to 1-Week and 8-Week Endpoints in 17-Item Hamilton Depression Rating Scale (HAMD-17) Anxiety/Somatization Subscale(Baseline, 1 week, 8 weeks)
- Percentage of Participants Achieving Response(Baseline up to 8 weeks)
- Percentage of Patients Achieving Remission(Baseline up to 8 weeks)
- Mean Change From Baseline to 1-Week and 8-Week Endpoints in Association for Methodology and Documentation in Psychiatry (AMDP-5) Measure: Gastric Events Score(Baseline, 1 week and 8 weeks)
- Mean Change From Baseline to 1-Week and 8-Week Endpoints in Clinical Global Impressions of Severity (CGI-S)(Baseline, 1 week, 8 weeks)
- Patient Global Impression of Improvement (PGI-I) at 1 Week and 8 Weeks(1 week, 8 weeks)
- Time to Resolve Nausea(Nausea onset up to nausea resolve (Baseline up to 8 weeks))
- Mean Change From Baseline to 1-Week and 8-Week Endpoints in 17-Item Hamilton Depression Rating Scale (HAMD-17) Sleep Subscale(Baseline, 1 week, 8 weeks)
- Time to Onset of Nausea(Baseline to onset of nausea (Baseline up to 8 weeks))
研究者
研究点 (1)
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