An Investigation of the Antidepressant Effects of an NMDA Antagonist in Treatment-Resistant Major Depression
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
- Montgomery-Asberg Depression Rating Scale (MADRS) Total Score.
研究概览
简要总结
The purpose of this study is to determine the antidepressant effects of AZD6765 compared to placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a diagnosis of Major Depressive Disorder, currently depressed without psychotic features
- •Females must be of non-childbearing potential.
排除标准
- •Treatment with Clozapine or ECT within 3 months prior to study
- •Current or past history of psychotic features or a diagnosis of schizophrenia or any other psychotic disorder as defined in the DSM-IV
研究组 & 干预措施
AZD6765 (150 mg) / Placebo
Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
干预措施: AZD6765 (Drug)
Placebo / AZD6765 (150 mg)
Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
干预措施: Placebo to AZD6765 (Drug)
结局指标
主要结局
Montgomery-Asberg Depression Rating Scale (MADRS) Total Score.
时间窗: 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing.
Montgomery-Asberg Depression Rating Scale (MADRS) is a 10-item instrument used for the evaluation of depressive symptoms. Each item is rated on a scale of 0 to 6 (with higher scores indicating more severe depression). The individual item scores are added together to form a total score, ranging between 0 and 60. 0 is considered the best score, 60 the worst.
次要结局
- The Number of Participants With Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than 10 (MADRS Remission).(60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing.)
- The Number of Participants With at Least 50% Reduction in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (MADRS Response).(60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing.)
- Scale for Suicide Ideation (SSI) Total Score.(60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing.)
- Hamilton Anxiety Rating Scale (HAM-A) Total Score.(60 minutes (min) prior to dosing (baseline); and 230 min, 1 day, 2 days, 3 days and 7 days following dosing.)
- Hamilton Depression Rating Scale-17 Item (HDRS) Total Score(60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing)
- Visual Analogue Scale (VAS) Depressed Score(60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing)
- Clinician-Administered Dissociative States Scale (CADSS) Score.(60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing)
- Brief Psychiatric Rating Scale (BPRS) Score.(60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing.)
- Young Mania Rating Scale (YMRS) Score.(60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing.)
- Beck Depression Inventory (BDI) Score.(60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing.)
- Visual Analogue Scale (VAS) Anxious Score.(60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing.)
- Brief Psychiatric Rating Scale (BPRS) Positive Score.(60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing.)