An Eight-Week, Randomized, Double Blind, Two Parallel Groups, Study to Assess Clinical Response of Duloxetine 60 mg and 120 Per Day in Patients Hospitalized for Severe Depression
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 339
- 试验地点
- 1
- 主要终点
- Change From Baseline to 4 Week Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
研究概览
简要总结
An eight-week, randomized, double blind, two parallel groups, study to assess clinical response of duloxetine 60 milligrams (mg) and 120 mg per day in patients hospitalized for severe depression.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients of ≥ 18 years of age that meet criteria for severe Major Depressive Disorder, without psychotic features (according to Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, [DSM-IV] and confirmed by Mini International Neuropsychiatric Interview [MINI]).
- •With a total score Montgomery-Asberg Depression Rating Scale (MADRS) ≥ 30 and 6-item Hamilton Depression Rating Scale (HAMD-6) ≥ 12 and Clinical Global Impression of Severity (CGI-Severity) ≥ 4 at both screening and baseline.
- •Requirement of hospitalization (not for social or other non-medical reasons) at screening visit and at least up to Visit
- •Patients willing and able to comply with the requirement for hospitalization and with all scheduled visits, tests and procedures required by the protocol.
- •Informed consent document must be signed at screening visit, in accordance with Good Clinical Practice (GCP) and local regulatory requirements, prior to any study procedure.
排除标准
- •More than two previous episodes of major depression that did not respond (according to investigator's opinion) to adequate doses and duration of two different antidepressant therapies.
- •Lack of response to at least two antidepressant therapies given at adequate doses for at least 6 weeks for the current depressive episode.
- •Concurrent presence of symptoms fulfilling criteria for any Axis I disorder other than anxiety disorders (with exception of the Obsessive-Compulsive Disorder (OCD)) or Major Depressive Disorder, in the investigator's judgment.
- •Any previous diagnosis of a bipolar disorder, schizophrenia or OCD.
- •Depression with catatonic features (according to DSM-IV), depression with post-partum onset, or organic mental disorders.
- •The presence of an Axis II disorder
研究组 & 干预措施
Duloxetine Hydrochloride (60 mg)
Up to Week 4: 60 milligrams (mg) every morning and placebo every evening, by mouth (PO).
Week 4 to Week 8: Responders continued on same dose as before; Nonresponders received 60 mg every morning and 60 mg every evening added to the placebo
干预措施: Duloxetine hydrochloride (Drug)
Duloxetine Hydrochloride (60 mg)
Up to Week 4: 60 milligrams (mg) every morning and placebo every evening, by mouth (PO).
Week 4 to Week 8: Responders continued on same dose as before; Nonresponders received 60 mg every morning and 60 mg every evening added to the placebo
干预措施: Placebo (Drug)
Duloxetine Hydrochloride (120 mg)
Up to Week 4: 60 mg every morning and 60 mg every evening, PO.
Week 4 to Week 8: Responders continued on same dose as before; Nonresponders continued as before with a placebo capsule added to the evening dose
干预措施: Duloxetine hydrochloride (Drug)
Duloxetine Hydrochloride (120 mg)
Up to Week 4: 60 mg every morning and 60 mg every evening, PO.
Week 4 to Week 8: Responders continued on same dose as before; Nonresponders continued as before with a placebo capsule added to the evening dose
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline to 4 Week Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
时间窗: Baseline to Week 4
Measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).
次要结局
- Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score From Baseline(Baseline to Weeks 1, 2, 3, 4, 6, 8)
- Clinical Global Impression of Improvement (CGI-I) at Each Visit(Weeks 1, 2, 3, 4, 6, 8)
- Evaluation of Rescue Options Based on Changes in the Montgomery-Asberg Depression Rating Scale (MADRS) and the 6-Item Hamilton Depression Scale (HAMD-6)(4 to 8 weeks)
- Number of Patients With Potentially Clinically Significant Laboratory Findings(over 8 weeks)
- Change in 6-Item Hamilton Depression Scale (HAMD-6) Total Scores From Baseline(Baseline to Weeks 1, 2, 3, 4, 6, 8)
- Clinical Global Impression of Severity (CGI-S) Scores at Each Visit(Baseline, Weeks 1, 2, 3, 4, 6, 8)
- Percentage of Responders(4 to 8 weeks)
- Utilization of Allowed Hypnotic and/or Anxiolytic Co-Medication(over 8 weeks)
- Patient Global Impression of Improvement (PGI-I) Score at Each Visit(Weeks 1, 2, 3, 4, 6, 8)
- Hamilton Anxiety Scale (HAMA) Score at Baseline and Weeks 4 and 8(Baseline and Weeks 4 and 8)
- Patients Reaching Remission(Week 8)
- Number of Participants Experiencing High Values for Vital Signs at Any Time During the Study(over 8 weeks)
- Reason for Living (RFL) Questionnaire Mean Scores at Baseline and Week 8(Baseline and Week 8)
- Change From Baseline to Week 4 and Week 8 in Weight(Baseline to Weeks 4 and 8)
- Discontinuations Due to Adverse Events (AE)(over 8 weeks)