A Multicenter, Open Label, Flexible-dose, Parallel-group Evaluation of the Cataractogenic Potential of Quetiapine Fumarate (Seroquel) and Risperidone (Risperdal) in the Long Term Treatment of Participants With Schizophrenia or Schizoaffective Disorder
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 1,098
- 试验地点
- 1
- 主要终点
- Presence of a Cortical (C) Type of Cataractogenic Potential Events in Participants as Assessed and Agreed by 2 Independent, Treatment-masked Ophthalmologists Using the Lens Opacities Classification System II (LOCS II ) Grading Scale
研究概览
简要总结
This Phase IV, randomized, parallel-group study is designed to evaluate the cataractogenic potential of quetiapine fumarate (SEROQUEL) compared with that of a putative non-cataractogenic antipsychotic medication risperidone (RISPERDAL). This study is being conducted to fulfill the SEROQUEL Phase IV commitment regarding evaluation of cataractogenic potential.
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
- •Men and women age 18 to 65
- •Both Eyes present with lenses intact (no previous cataract extractions)
- •Stable place of residency
排除标准
- •History of corneal surgery
- •Legal blindness (defined as best corrected visual acuity of 20/200 or worse in one or both eyes
- •Previous participation in this study
研究组 & 干预措施
1
Quetiapine fumarate
干预措施: quetiapine fumarate (Drug)
2
Risperidone
干预措施: risperidone (Drug)
结局指标
主要结局
Presence of a Cortical (C) Type of Cataractogenic Potential Events in Participants as Assessed and Agreed by 2 Independent, Treatment-masked Ophthalmologists Using the Lens Opacities Classification System II (LOCS II ) Grading Scale
时间窗: Randomization to Month 24
Presence of C type of cataractogenic potential event in participant was defined if any LOCS II grades of 2, 3, 4, 5 (with any grade of 0, trace,1 at randomization) assessed and agreed by 2 independent, treatment-masked ophthalmologists at any post-randomization assessment in one or both eyes. 0= no cataract; 5 is worst. There are no subscales. 0 is the best, 5 is the worst.
Presence of a Nuclear Opalescence (N) Type of Cataractogenic Potential Events in Participants as Assessed and Agreed by 2 Independent, Treatment-masked Ophthalmologists Using the LOCS II Grading Scale
时间窗: Randomization to Month 24
Presence of N type of cataractogenic potential event in Participants was defined if any LOCS II grades of 2, 3, 4 (with grade at rand equals 0,1), or if the LOCS II grades of 3,or 4 (with grade at randomization=2) assessed and agreed by 2 independent, treatment-masked ophthalmologists at any post-randomization assessment in one or both eyes. 0 is the best, 4 is the worst.
Presence of a Posterior Subcapsular (P) Type Cataractogenic Potential Events in Participants as Assessed and Agreed by 2 Independent, Treatment-masked Ophthalmologists Using the LOCS II Grading Scale
时间窗: Randomization to Month 24
Presence of P type of cataractogenic potential event in participant was defined if any LOCS II grades of 1, 2, 3 , 4 (with grade=0 at randomization) assessed and agreed by 2 independent, treatment-masked ophthalmologists at any post-randomization assessment in one or both eyes. 0 is the best, 4 is the worst.
次要结局
- Change in the Positive and Negative Syndrome Scale (PANSS) Total Score(Randomization to Month 24)
- Change in the PANSS Positive Subscale Score(Randomization to Month 24)
- Change in the PANSS Negative Subscale Score(Randomization to Month 24)
- Change in the PANSS Psychopathology Subscale Score(Randomization to Month 24)
- Change in the Clinical Global Impression - Severity of Illness (CGI-S) Score(Randomization to Month 24)
- Change in Health-related Quality of Life as Measured by Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q SF) Total Score(Randomization to Month 24)
- Change in Personal Evaluation of Transitions in Treatment (PETiT) Total Score(Randomization to Month 24)
- Number of Relapses of Schizophrenia or Schizoaffective Disorder(At Month 24)
- Change in Simpson-Angus Scale (SAS) Total Score(Randomization to Month 24)
- Change in Barnes Akathisia Rating Scale (BARS) Global Score(Randomization to Month 24)
- Change in Abnormal Involuntary Movement Scale (AIMS) Total Score(Randomization to Month 24)
- Number of Participants With Potential Extrapyramidal Symptoms (EPS)(From start of the study treatment to last dose plus 30 days)