A Randomised, 6-week, Multicentre, Open-label, Rater-blinded Parallel Group Study Comparing Quetiapine Extended Release Monotherapy and Augmentation With Lithium Augmentation in Patients With Treatment Resistant Depression
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 688
- 试验地点
- 1
- 主要终点
- Change in Depressive Symptoms Between Randomisation and Week 6 Measured by Change in Montgomery Asberg Depression Rating Scale (MADRS) Total Score (Per Protocol Analysis Set)
研究概览
简要总结
The primary objective of the study is to evaluate the efficacy of Quetiapine extended release (XR) in combination with an selective serotonin reuptake inhibitor (SSRI) or Venlafaxine versus Lithium in combination with an selective serotonin reuptake inhibitor or Venlafaxine versus Quetiapine extended release monotherapy in subjects with treatment resistant depression as assessed by the changes from randomisation to week 6 in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score. As an independent objective, the primary objective will also be evaluated in two subgroups of patients: (1) patients who were resistant to two previous antidepressant therapies and (2) in the subgroup of patients with one previous failure.
详细描述
The secondary objectives of the study are to compare the effects of the three different treatment regimen as assessed by the following variables and, if applicable, by their changes from randomisation to week 6 (end of study). Additionally the time of onset of therapeutic effect will be assessed by evaluating efficacy data after the first four days (Day 4) of treatment as well as after the first week of treatment (Day 8). These analyses will also be performed in the subgroups of patients with 2 failed previous antidepressants and patients with 1 failure.
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
- None
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
- •Documented clinical diagnosis as confirmed by the M.I.N.I. meeting criteria from the Diagnostic and Statistical Manual of Mental disorders, 4th Edition (DSM-IV) for any of the following:296.2x MDD, Single Episode296.3x MDD, Recurrent Episode
- •Current episode of depression present, at least 42 days prior to enrolment but not more than 18 months
- •MADRS-Score ≥ 25 at enrolment and randomisation
排除标准
- •Patients with a DSM-IV Axis I disorder other than MDD within 6 months of randomisation
- •Patients with a diagnosis of DSM-IV Axis II disorder which has a major impact on the patient's current psychiatric status
- •Patients who, in the investigator's judgment pose a current serious suicidal or homicidal risk, or have made a suicide attempt within the past 6 months
研究组 & 干预措施
Add-on Quetiapine XR+SSRI/Venlafaxine
Selective serotonin reuptake inhibitors (SSRI) or Venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od).
From previous anti-depressant treatment 64% of the patients had SSRI and 35% had Venlafaxine at baseline.
干预措施: Quetiapine XR (Drug)
Add-on Quetiapine XR+SSRI/Venlafaxine
Selective serotonin reuptake inhibitors (SSRI) or Venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od).
From previous anti-depressant treatment 64% of the patients had SSRI and 35% had Venlafaxine at baseline.
干预措施: SSRI/Venlafaxine (Drug)
Add-on Lithium+SSRI/Venlafaxine
Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od).
From previous anti-depressant treatment 67% of the patients had SSRI and 33% had Venlafaxine at baseline.
干预措施: Lithium carbonate (Drug)
Add-on Lithium+SSRI/Venlafaxine
Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od).
From previous anti-depressant treatment 67% of the patients had SSRI and 33% had Venlafaxine at baseline.
干预措施: SSRI/Venlafaxine (Drug)
Monotherapy Quetiapine XR
Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
干预措施: Quetiapine XR (Drug)
结局指标
主要结局
Change in Depressive Symptoms Between Randomisation and Week 6 Measured by Change in Montgomery Asberg Depression Rating Scale (MADRS) Total Score (Per Protocol Analysis Set)
时间窗: 6 weeks treatment
Change in LS mean total Montgomery Asberg Depression Rating Scale (MADRS) score from randomisation to end-of-treatment (week 6) (Scale 0-60), lower score indicates a better health status.
Change in Depressive Symptoms Between Randomisation and Week 6 Measured by Change in Montgomery Asberg Depression Rating Scale (MADRS) Total Score (Modified Intention to Treat Analysis Set)
时间窗: 6 weeks of treatment
Change in LS mean total Montgomery Asberg Depression Rating Scale (MADRS) score from randomisation to end-of-treatment (week 6) (Scale 0-60), lower score indicates a better health status.
次要结局
- Depression Remission; Montgomery-Asberg Depression Rating Scale MADRS ≤10, All Patients(6 weeks of treatment)
- Depression Remission; Montgomery-Asberg Depression Rating Scale (MADRS) ≤10, Patients With One Previous Treatment Failure(6 weeks of treatment)
- Depression Remission; Montgomery-Asberg Depression Rating Scale (MADRS) ≤10, Patients With Two Previous Treatment Failure(6 weeks of treatment)
- Depression Remission; Montgomery-Asberg Depression Rating Scale (MADRS) ≤8(6 weeks of treatment)
- Depression Remission; Montgomery-Asberg Depression Rating Scale (MADRS) ≤12(6 weeks of treatment)
- Response Rate; Montgomery-Asberg Depression Rating Scale (MADRS) Score Reduced ≥ 50%, All Patients(6 week of treatments)
- Response Rate; Montgomery-Asberg Depression Rating Scale (MADRS) Score Reduced ≥ 50%, Patients With One Previous Treatment Failure(6 weeks of treatment)
- Response Rate; Montgomery-Asberg Depression Rating Scale (MADRS) Score Reduced ≥ 50%, Patients With Two Previous Treatment Failure(6 weeks of treatment)
- Responder: Clinical Global Impression Improvement (CGI-I) Item 2, All Patients(6 weeks of treatment)
- Responder: Clinical Global Impression Improvement (CGI)-I Item 2, Patients With One Previous Treatment Failure(6 weeks of treatment)
- Responder: Clinical Global Impression Improvement (CGI-I) Item 2, Patients With Two Previous Treatment Failure(6 weeks of treatment)
- Change in Clinical Global Impression Scale (CGI-S), All Patients(6 weeks of treatment)
- Change in Clinical Global Impression Scale (CGI-S), Patients With One Previous Treatment Failure(6 weeks of treatment)
- Change in Clinical Global Impression Scale (CGI-S), Patients With Two Previous Treatment Failure(6 weeks of treatment)
- Change in Beck Depression Inventory (BDI)(6 weeks of treatment)
- Change in Pain, Measured by Visual Analog Scale (VAS)(6 weeks of treatment)
- Change in Anxiety Measured by Visual Analog Scale (VAS)(6 weeks of treatment)
- Change in Anxiety Measured by State-Trait Anxiety Inventory (STAI), State Anxiety Inventory(6 weeks of treatment)
- Change in Anxiety Measured by STAI, Trait Anxiety Inventory(6 weeks of treatment)
- Change in Sleep Quality Measured by Montgomery Asberg Depression Rating Scale (MADRS), Item 4(6 weeks of treatment)
- Change in Sleep Quality Measured by Pittsburgh Sleep Quality Index (PSQI)(6 weeks of treatment)
- Change in Quality of Life Measured by Short-form Health Survey (SF-36), Mental Component(6 weeks of treatment)
- Change in Quality of Life Measured by Short-form Health Survey (SF-36), Physical Component(6 weeks of treatment)
- Change in Quality of Life Measured by Health Questionnaire EQ-5D as Utility(6 weeks of treatment)
- Change in Work Productivity and Activity Impairment: General Health (WPAI:GH)(6 weeks of treatment)
- Change in Clinical Global Impression (CGI) Item 4 Efficacy and Safety Combined, All Patients(6 weeks of treatment)
- Change in Clinical Global Impression (CGI) Item 4 Efficacy and Safety Combined, Patients With One Previous Treatment Failure(6 weeks of treatment)
- Change in Clinical Global Impression (CGI) Item 4 Efficacy and Safety Combined, Patients With Two Previous Treatment Failures(6 week of treatments)