An Investigation of the Antidepressant Efficacy of a Selective, High, Affinity Enkephalinergic Agonist in Anxious Major Depressive Disorder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Hamilton Rating Scale for Depression (HAM-D) Total Score.
研究概览
简要总结
This study will determine if a highly selective enkephalinergic receptor modulator is effective in the treatment of anxious major depressive disorder.
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
- Double (Participant, Investigator)
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
- •Provision of informed consent prior to any study specific procedures
- •Diagnosis of major depressive disorder without psychotic features (MDD)
排除标准
- •A history of substance or alcohol abuse within the past 6 months or dependence within 1 year of enrollment as defined by DSM-IV criteria.
- •Women that are pregnant or lactating
- •History of pancreatitis
研究组 & 干预措施
AZD2327
AZD2327 3mg BID
干预措施: AZD2327 (Drug)
Placebo
Placebo BID
干预措施: Placebo (Drug)
结局指标
主要结局
Hamilton Rating Scale for Depression (HAM-D) Total Score.
时间窗: Week 4
Hamilton Rating Scale for Depression (HAM-D)is a 17-item, clinician-rated scale that assesses depressive symptoms. The HAMD-17 consists of 17 symptoms, each of which is rated from 0 to 2 or 0 to 4, where 0 is none/absent. The HAMD-17 total score is calculated as the sum of the 17 individual symptom scores; the total score can range from 0 to 52. Higher HAMD-17 scores indicate more severe depression.
Hamilton Rating Scale for Anxiety (HAM-A) Total Score.
时间窗: Week 4
The Hamilton Rating Scale for Anxiety (HAM-A) is used as a rating measure of anxiety severity. The scale consists of 14 items. Each item is rated on a scale of 0 to 4. The HAM-A total score is the sum of the 14 items and the score ranges from 0 to 56, 0 is considered the best outcome.
次要结局
- Psychic Anxiety Item of the Hamilton Rating Scale for Depression (HAM-D).(Week 4)
- The Number of Participants With at Least 50% Reduction of Hamilton Rating Scale for Depression (HAM-D)Total Score.(Randomization to week 4)
- The Number of Participants With at Least 50% Reduction of Hamilton Rating Scale for Anxiety (HAM-A)Total Score.(Randomization to week 4)