A Phase II, Multi-center, Randomized, Double-bind, Double-dummy, Active and Placebo Controlled, Parallel Group Study to Assess the Efficacy and Safety of AZD7268 in Patients With Major Depressive Disorder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 247
- 试验地点
- 1
- 主要终点
- Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score Change From Baseline to Week 4.
研究概览
简要总结
The purpose of this study is to prove the principle that treatment with AZD7268 reduces depressive symptoms in patients with Major Depressive Disorder (MDD) compared with placebo.
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
- 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 signed, written, and dated Informed Consent prior to any study specific procedures
- •Documented primary clinical diagnosis meeting criteria from the DSM-IV, Text Revision (APA 2000) for any of the following:
- •296.2x Major Depressive Disorder, Single Episode, or
- •296.3x Major Depressive Disorder, Recurrent
排除标准
- •Patients with a secondary DSM-IV Axis I disorder other than GAD or social anxiety disorder (as assessed by MINI), provided the primary diagnosis is MDD. This diagnosis should have been made at least 6 months before enrollment
- •Patients with a diagnosis of DSM-IV Axis II disorder which has a major impact on the patient's current psychiatric status
- •Patients whose current episode of depression started less than 4 weeks before enrollment
研究组 & 干预措施
AZD7268
The AZD7268 15 mg BID arm consisted of 3 AZD7268 5 mg capsules dosed orally in the morning and evening. In addition, 2 placebo tablets to match encapsulated escitalopram tablets were dosed orally in the morning only.
干预措施: AZD7268 (Drug)
AZD7268
The AZD7268 15 mg BID arm consisted of 3 AZD7268 5 mg capsules dosed orally in the morning and evening. In addition, 2 placebo tablets to match encapsulated escitalopram tablets were dosed orally in the morning only.
干预措施: Placebo tablets (Drug)
Placebo
The placebo arm consisted of 3 placebo capsules to match AZD7268 capsules dosed orally in the morning and evening. In addition, 2 placebos to match encapsulated escitalopram tablets were dosed orally in the morning only.
干预措施: Placebo capsules (Drug)
Placebo
The placebo arm consisted of 3 placebo capsules to match AZD7268 capsules dosed orally in the morning and evening. In addition, 2 placebos to match encapsulated escitalopram tablets were dosed orally in the morning only.
干预措施: Placebo tablets (Drug)
Escitalopram
The escitalopram 20 mg QD arm consisted of 3 placebo to match AZD7268 capsules dosed orally in the morning and evening. In addition, during Week 1, one encapsulated 10-mg escitalopram tablet and 1 placebo to match encapsulated escitalopram tablet were dosed orally in the morning only. During Weeks 2 through 4, two encapsulated 10-mg escitalopram tablets were dosed orally in the morning only.
干预措施: Escitalopram (Drug)
Escitalopram
The escitalopram 20 mg QD arm consisted of 3 placebo to match AZD7268 capsules dosed orally in the morning and evening. In addition, during Week 1, one encapsulated 10-mg escitalopram tablet and 1 placebo to match encapsulated escitalopram tablet were dosed orally in the morning only. During Weeks 2 through 4, two encapsulated 10-mg escitalopram tablets were dosed orally in the morning only.
干预措施: Placebo capsules (Drug)
结局指标
主要结局
Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score Change From Baseline to Week 4.
时间窗: Baseline, Week 4
MADRS total score, sum of 10 item scores (each on a 0 (best value) to 6 (worst value)scale), assesses the severity of depressive symptoms on a continuous scale from 0 (the best) to 60 (the worst). Change from baseline was calculated as Week 4 value minus baseline value. \[observed cases, Mixed Model Repeated Measurement (MMRM), Full Analysis Set (FAS)\]
次要结局
- Montgomery-Åsberg Depression Rating Scale (MADRS) Response(Week 4)
- Montgomery-Åsberg Depression Rating Scale (MADRS) Remission(Week 4)
- Hamilton Rating Scale for Depression (HAM-D) Total Score Change From Baseline to Week 4.(Baseline, Week 4)
- Clinical Global Impression - Severity (CGI-S) Score Change From Baseline(Baseline, Week 4)
- Hamilton Rating Scale for Anxiety (HAM-A) Total Score Change From Baseline(Baseline, Week 4)