A Randomized, Multi-center, Double-blind, Placebo-controlled, Parallel-group Comparison Trial to Assess Efficacy and Safety of OPC-64005 in Patients With Major Depressive Disorder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 273
- 试验地点
- 1
- 主要终点
- Mean Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 6 of the Double-blind Treatment Period
研究概览
简要总结
The objective of the trial is to compare the efficacy of OPC-64005 at 20 mg vs placebo and to assess the safety and pharmacokinetics of OPC-64005 at 10 and 20 mg in patients with major depressive disorder (MDD).The primary endpoint is the mean change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6 of the double-blind treatment period in the OPC-64005 20-mg group compared with the placebo group
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
- 20 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a DSM-5 classification-based diagnosis of "major depressive disorder, single episode" or "major depressive disorder, recurrent episode" with the current episode persisting for ≥4 weeks to ≤1 year
- •Patients with a total score of ≥18 on the 17-item Hamilton Rating Scale for Depression (HAM-D)
排除标准
- •Patients with a diagnosis of any of the following diseases according to DSM-5 Neurocognitive disorders, history or complication of schizophrenia spectrum or other psychotic disorder, history or complication of bipolar and related disorders, feeding and eating disorders, obsessive-compulsive disorder, panic disorder, posttraumatic stress disorder, personality disorders, neurodevelopmental disorders, substance-related and addictive disorders (within 180 days prior to informed consent)
- •Patients exhibiting mood-incongruent psychotic features in the current major depressive episode
- •Patients who, in the opinion of the investigator or subinvestigator, are judged to have treatment-resistant depression, ie, a certain degree of therapeutic effect is not obtained by administration of 2 or more antidepressants having different mechanisms of action at sufficient doses for at least 6 weeks for the current major depressive episode
- •Patients receiving augmentation treatment, such as antipsychotics, for the current major depressive episode (excluding the use of sulpiride for depression/depressive state or gastric/duodenal ulcer)
研究组 & 干预措施
OPC-64005 20 mg
干预措施: OPC-64005 20 mg , Once-daily (Drug)
OPC-64005 10 mg
干预措施: OPC-64005 10 mg , Once-daily (Drug)
Placebo
干预措施: Placebo, Once-daily (Drug)
结局指标
主要结局
Mean Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 6 of the Double-blind Treatment Period
时间窗: Baseline, Week 1, 2, 3, 4, 5, and 6
The MADRS was a clinician-rated scale which evaluated the level of depression. The MADRS consists of following 10 depressive symptoms on 7 scales of 0 to 6, with higher scores indicating worse condition. 1. Apparent sadness, 2. Reported sadness, 3. Inner tension, 4. Reduced sleep, 5. Reduced appetite, 6. Concentration difficulties, 7. Lassitude, 8. Inability to feel, 9. Pessimistic thoughts, and 10. Suicidal thoughts Summed subscales were combined to compute a total score. Total score ranges form 0 to 60, with higher scores indicating worse condition.
次要结局
- MADRS Response Rate(Baseline, Week 1, 2, 3, 4, 5, and 6)
- MADRS Remission Rate(Week6)