Comparison of Quetiapine Extended-Release (Seroquel XR™) and Risperidone in the Treatment of Depressive Symptoms, in Schizophrenic or Schizoaffective Patients: A Randomized, Open Label, Flexible-dose, Parallel Group, Non Inferiority, 12-week Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 216
- 试验地点
- 1
- 主要终点
- Change From Baseline to Week 12 of Calgary Depression Scale for Schizophrenia (CDSS) Score.
研究概览
简要总结
Aim of the study is to assess if the new compound Seroquel XR™ is non-inferior to Risperidone, considered as the reference drug for the treatment of depressive symptoms of schizophrenia.
PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.
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
- •Provision of written informed consent
- •Patients who satisfy the criteria for diagnosis of schizophrenia or schizoaffective disorder according to DSM-IVTR
- •Baseline depressive symptoms, assessed by means of HAM-D (21-item) score ≥20, and HAM-D item 1 score ≥2
排除标准
- •Any DSM-IV Axis I disorder other than schizophrenia and schizoaffective disorder
- •Patients treated with depot antipsychotic medications within 1 dosing interval before day 0; patients treated with other AP oral medications during the trial except for the switch period
- •Use of Clozapine within 28 days prior to enrollment or Clozapine non responders
- •Any significant clinical disorder that, in the opinion of the investigator, made the subject unsuitable to be given treatment with an investigational drug
- •An absolute neutrophil count (ANC) of ≤1.5 x 109 per liter
- •Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others.
研究组 & 干预措施
Quetiapine Extended Release
干预措施: Quetiapine Extended Release (Drug)
Risperidone
干预措施: Risperidone (Drug)
结局指标
主要结局
Change From Baseline to Week 12 of Calgary Depression Scale for Schizophrenia (CDSS) Score.
时间窗: 12 week from baseline to last visit
The CDSS scale is used to assess the level of depression in schizophrenia and to estimate the severity of depressive symptoms. CDSS has 9 items rated on four-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Anchor point descriptions are provided to aid differentiation between each item score. The first eight items are rated on basis of patients' responses to questions; the 9 item is based on clinician's assessment. The sum score is derived by adding the point score of all items (from 0 to 27 points); total score 4-5 is considered for minor depression and 6-7 score for major depression.
次要结局
- Change From Baseline to Week 12 of HAM-D Score(12 weeks from baseline to last visit)
- Change From Baseline to Week 12 of PANSS Score(12 weeks from baseline to last visit)
- - Change From Baseline to Week 12 of Clinical Global Impression (CGI- Severity of Illness) Score(12 weeks from baseline to last visit)
- CGI- Global Improvement Mean Score at Week 12(12week: descriptive statistic of CGI by visit and treatment)
- Change From Baseline to Week 12 of Drug Attitude Inventory 10 Item Scale (DAI 10) Score(12 week from baseline to last visit)
- Change From Baseline in the Simpson Angus Scale (SAS) Total Score to Week 12 as an Indication of Neurological Side Effects Section(12 weeks from baseline to last visit)
- Concomitant Use of Antidepressive Drugs From Baseline to Week 12(Change of drug use from baseline to last visi)
- Change From Screening Visit to Week 12 of Prolactin Live(12 week from screening visit to last visit)
- Body Mass Index (BMI) at Week 12(12 week)