JPRN-jRCT2080225024已完成2 期
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
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 273
研究概览
简要总结
The primary endpoint of mean change from baseline in MADRS total score at Week 6 of the double-blind treatment period was numerically greater in the 20-mg group than in the placebo group, but statistical superiority of the 20-mg group to the placebo group was not demonstrated.No major safety concerns were observed in either the 20-mg or 10-mg group and OPC-64005 was well tolerated.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 64age old（—）
- 性别
- All
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 and more than 4 weeks to 1 and less than 1 year
- •- Patients with a total score of 18 and more than 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)
研究者
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