CARE II - Evaluation of Treatment Outcomes in Schizophrenic Patients Taking Part in the Integrated Care Program - a Single-country, Multi-centre Phase IV Study
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- AstraZeneca
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Subjective Well-being in Patients Treated for Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder, Delusional Disorder or Psychotic Disorder Not Otherwise Specified Using the SWN-K (Subjective Well-being Under Neuroleptics) Scale
研究概览
简要总结
The purpose of the study is to investigate the well-being of schizophrenic patients treated with quetiapine XR combined with participation in the integrated care program compared to a treatment with quetiapine XR alone over a period of 18 month
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Patients with baseline SWN-K <=70
- •Provision of signed informed consent
- •Out-patients with schizophrenia, schizophreniform disorder or schizoaffective disorder, severe postpartum depressive disorders with psychotic symptoms and a minimum HAM-D cut off score of 20 points
排除标准
- •Evidence of a clinical relevant disease, eg renal or hepatic impairment, significant coronary heart disease, hepatitis B or C, AIDS
- •Patients with known cardiovascular disease or other condition predisposing to hypotension or family history of QT prolongation
- •Patients who pose an imminent risk of suicide or danger to self or others
研究组 & 干预措施
Quetiapine XR Alone
Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
干预措施: Quetiapine XR (Drug)
Quetiapine XR With Integrated Care Program (ICP)
Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
干预措施: Quetiapine XR (Drug)
Quetiapine XR With Integrated Care Program (ICP)
Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
干预措施: Integrated Care Program (ICP) (Other)
结局指标
主要结局
Subjective Well-being in Patients Treated for Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder, Delusional Disorder or Psychotic Disorder Not Otherwise Specified Using the SWN-K (Subjective Well-being Under Neuroleptics) Scale
时间窗: 4 months
The SWN-K is comprised of 20 questions, each of which is rated using a 6 point scale ranging from 1 (not at all) to 6 (very much). Possible scores range from 20-120, with higher scores implying higher subjective well-being.
次要结局
- Subjective Well-being Using the SWN-K (Subjective Well-being Under Neuroleptics Scale) Total Score(4 month)
- Symptomatic Outcome Using CGI-S (Clinical Global Impression-Schizophrenia) Scale(4 month)
- Symptomatic Outcome Using the PANSS-8 Scales(Positive and Negative Symptoms) Scale Score(4 month)
- GAF (Global Assessment of Functioning) Scale Score(4 month)
- PSP (Personal and Social Performance) Scale Score(4 month)
- EQ-5D (European Quality of Life Questionnaire) Score(4 month)
- Vocational Occupational Index "VOC" Score(Up to 18 months (V1 Day 1, V2 Month 1, V3 Month 3, V4 Month 6, V5 Month 12, V6 Month 18))
- Assess Quality of Life Levels Using the Q-LES-Q-18 (Quality of Life Enjoyment and Satisfaction) Questionnaire(4 month)
- Assess Quality of Life Levels Using the RSM Scale (Riedel-Spellmann-Musil) Scale(4 month)
- Assess Patient Engagement to Therapy Using the SES Scale (Service Engagement Scale)(4 month)
- Assess Compliance/Medication Adherence Using the MARS Scale (Medication Adherence Rating Scale)(4 month)
- Evaluate the Level of the Patients' (Subjective) Satisfaction Using the CSQ-8 Scale (Client Satisfaction Questionnaire)(4 month)
- Assess Health Economy Improvements in Terms of a Reduction in Treatment Costs and Loss of Productivity by Determination of the Total Cost by Number of Days With Hospitalization(4 month)
- Assess Health Economy Improvements in Terms of a Reduction in Treatment Costs and Loss of Productivity by Determination of the Total Number of Days the Patient Was Not Able to Work or go to School or Complete Routine Daily Activities(4 month)
- Assess Health Economy Improvements in Terms of a Reduction in Treatment Costs and Loss of Productivity by Determination of the Need for Any Additional Antipsychotic Medication(4 month)
- Evaluate Safety and Tolerability by Evaluation of Weight/Waist Circumference(4 month)
- Evaluate Safety and Tolerability by Evaluation of Laboratory Tests(4 month)
- Evaluate Safety and Tolerability by Evaluation of Concomitant Medication(4 month)
- Evaluate Safety and Tolerability by Evaluation of the Incidence of Adverse Events(4 month)