A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of OPC-34712 as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 850
- 试验地点
- 50
- 主要终点
- Change From the End of Phase A (Week 8 Visit) to the End of Phase B (Week 14 Visit) in Montgomery Asberg Depression Rating Scale (MADRS) Total Score.
研究概览
简要总结
Primary: To compare the efficacy of OPC-34712 to placebo as adjunctive treatment to an assigned open-label marketed antidepressant treatment (ADT)in patients who demonstrate an incomplete response to a prospective eight week trial of the same assigned open-label marketed ADT.
详细描述
A comparison of the Fixed dose arm (OPC-31712, 0.15 mg) verses placebo was included as a general secondary efficacy variable and results for this dose group comparison are included under each of the Outcome Measures.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects between 18 and 65 years of age, with diagnosis of major depressive disorder, as defined by DSM-IV-TR criteria
- •The current depressive episode must be equal to or greater than 8 weeks in duration
- •Subjects must report a history for the current depressive episode of an inadequate response to at least one and no more than three adequate antidepressant treatments.
排除标准
- •Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving study drug.
- •Subjects who report an inadequate response to more than three adequate trials of antidepressant treatments during current depressive episode at a therapeutic dose for an adequate duration.
- •Subjects with a current Axis I (DSM-IV-TR) diagnosis of:
- •Delirium, dementia,amnestic or other cognitive disorder
- •Schizophrenia, schizoaffective disorder, or other psychotic disorder
- •Bipolar I or II disorder
- •Subjects with a clinically significant current Axis II (DSM-IV-TR)
- •diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality disorder.
研究组 & 干预措施
1
OPC-34712 + ADT
干预措施: OPC-34712 (Drug)
1
OPC-34712 + ADT
干预措施: ADT (Drug)
2
Placebo + ADT
干预措施: Placebo (Drug)
2
Placebo + ADT
干预措施: ADT (Drug)
结局指标
主要结局
Change From the End of Phase A (Week 8 Visit) to the End of Phase B (Week 14 Visit) in Montgomery Asberg Depression Rating Scale (MADRS) Total Score.
时间窗: Week 8 to Week 14
The MADRS is utilized as the primary efficacy assessment of a participant's level of depression. The MADRS consists of 10 items, all rated on a 0 to 6 scale with 0 being the "best" rating and 6 being the "worst" rating. The MADRS Total Score is the sum of ratings for all 10 items. The possible Total scores are from 0 to 60. The MADRS Total Score was unevaluable if less than 8 of the 10 items are recorded. If 8 or 9 of the 10 items were recorded, the MADRS Total Score was the mean of the recorded items multiplied by 10 and then rounded to the first decimal place.
次要结局
- Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Mean Clinical Global Impression - Severity of Illness Scale (CGI-S) Score.(Week 8 to Week 14)
- Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Mean Quality of Life, Enjoyment, and Satisfaction Questionnaire - Short Form (QLES-Q-SF) Subscale Score - the Overall General Subscore (Sum of First 14 Items).(Week 8 to Week 14)
- Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Sheehan Disability Scale (SDS) Mean Score (the Mean of 3 Individual Item Scores).(Week 8 to Week 14)
- Change From End of Phase A (Week 8 Visit) in MADRS Total Score for Every Study Week Visit in Phase B Other Than the Week 14 Visit.(Week 8 to each of Week 9, 10, 11, 12 and 13.)
- Change From End of Phase A (Week 8 Visit) in Mean CGI-S Score for Every Study Week Visit in Phase B Other Than the Week 14 Visit.(Week 8 to each of Week 9, 10, 11, 12 and 13.)
- Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Mean Q-LES-Q-SF Item 15 Score (Satisfaction With Medication).(Week 8 to Week 14)
- Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Mean Q-LES-Q-SF Item 16 Score (Overall Life Satisfaction).(Week 8 to Week 14)
- Change From End of Phase A (Week 8 Visit) for Every Study Week Visit in Phase B in Inventory of Depressive Symptomatology (Self-Report) (IDS-SR) Total Score.(Week 8 to each of Week 9, 10, 11, 12, 13 and 14)
- Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Hamilton Depression Rating Scale (HAM-D17) Score.(Week 8 to Week 14)
- Clinical Global Impression-Improvement Scale (CGI-I) Score at Each Study Week Visit in Phase B.(Week 8 to each of Week 9, 10, 11, 12, 13 and 14.)
- Percentage of Participants With MADRS Response From End of Phase A (Week 8 Visit).(Week 8 to each of Week 9, 10, 11, 12, 13 and 14.)
- Percentage of Participants With MADRS Remission From End of Phase A (Week 8 Visit).(Week 8 to each of Week 9, 10, 11, 12, 13 and 14.)
- Percentage of Participants With CGI-I Response From End of Phase A (Week 8 Visit).(Week 9, 10, 11, 12, 13 and 14.)