Open Extension Study Evaluating The Long Term Efficacy , Safety And Tolerability Of Oral Ziprasidone In The Treatment Of Patients Who Have Successfully Completed The Previous Ziprasidone Study A1281031
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)
研究概览
简要总结
Open label extension study of Ziprasidone, evaluation of safety of long term use of ziprasidone
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who successfully completed study A1281031 (CGI score of 1 or 2 at final visit) or ZIP-NY-98035 and with QTc <= 500 msec.
排除标准
- •All other patients who do not fit the inclusion criteria as stated above.
研究组 & 干预措施
A1
干预措施: Ziprasidone (Drug)
结局指标
主要结局
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)
时间窗: Baseline, 3 months, 6 months, 1 year, 3 years, 5 years, End of Study [LOCF]
CGI-I consists of a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale.
Change From Baseline in CGI-I at End of Study (up to 5 Years)
时间窗: Baseline, up to 5 years (End of Study [LOCF])
CGI-I consists of a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Change from baseline is score at observation minus score at baseline.
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)
时间窗: Baseline, 3 months, 6 months, 1 year, 3 years, 5 years, End of Study [LOCF]
CGI-S Scale: standardized assessment tool to rate severity of subject's illness; assessed investigator's impression of subject's current illness state. Score: 1 (normal - not ill at all) to 7 (among the most extremely ill patients).
Change From Baseline in CGI-S at End of Study (up to 5 Years)
时间窗: Baseline, up to 5 years (End of Study [LOCF])
CGI-S Scale: standardized assessment tool to rate severity of subject's illness; assesses investigator's impression of subject's current illness state. Score: 1 (normal - not ill at all) to 7 (among the most extremely ill). Change: score at observation minus score at baseline.
次要结局
- Number of Participants With Scores on Patient Preference Scale (PPS)(Baseline, up to 5 years (End of Study))
- Change From Baseline in Drug Attitude Inventory (DAI) at End of Study (up to 5 Years)(Baseline, up to 5 years (End of Study))