NCT00141271已完成3 期
A Six-Week, Randomized, Double-Blind, Multicenter, Fixed-Flexible Dose, Placebo-Controlled Study Evaluating the Efficacy and Safety of Oral Ziprasidone in Outpatients With Bipolar I Depression
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 个研究点 分布在 1 个国家目标入组 536 人开始时间: 2005年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 536
- 试验地点
- 1
- 主要终点
- Change in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score
研究概览
简要总结
This is a 6-week trial that evaluates the efficacy and safety of Geodon (ziprasidone) in outpatient subjects ages 18 and older with Bipolar Disorder type I, depressed. Subjects are required to undergo a washout period of at least 7 days of any prior med.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must have a primary diagnosis of Bipolar I Disorder, most recent episode depressed, with or without rapid cycling, without psychotic features, as defined in Diagnostic and Statistical Manual (of Mental Disorders) - Fourth Edition - Text Revision (DSM-IV-TR) (296.5X) and confirmed by a structured Mini International Neuropsychiatric Interview (MINI)
排除标准
- •Subjects with a DSM-IV TR diagnosis of schizophrenia (295.XX), schizoaffective disorder (295.70), schizophreniform disorder (295.40), delusional disorder (297.1), or psychotic disorder not otherwise specified (298.9).
- •Subjects with other DSM-IV TR Axis I or Axis II disorder (in addition to Bipolar I disorder) are ineligible if the comorbid condition is clinically unstable, requires treatment, or has been a primary focus of treatment within the 6 month period prior to screening.
研究组 & 干预措施
20-40mg BID arm
Active Comparator
干预措施: Geodon (Ziprasidone) (Drug)
60-80mg bid arm
Active Comparator
干预措施: Geodon (Ziprasidone) (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score
时间窗: Baseline to 6 weeks
Change is observed value at each visit minus baseline value. Overall is average response of Weeks 1 - 6. MADRS is 10-item instrument measuring depression; scale 0(Normal) and 6(most abnormal). Total possible score is 0 - 60.
次要结局
- Response Greater Than or Equal to 50 Percent Decrease From Baseline in Hamilton Depression Rating Scale (HAM-D 17) Total Score(Baseline to 6 weeks)
- Change in Global Assessment of Functioning (GAF)at Endpoint, Last Observation Carried Forward (LOCF)(Baseline, 6 Weeks LOCF)
- Remission as Measured by Hamilton Depression (HAM-D 17) Total Score Less Than or Equal to 7(Baseline to 6 weeks)
- Change in Hamilton Depression (HAM-D 17) Total Score(Baseline to 6 weeks)
- Change in Hamilton Anxiety Rating (HAM-A)(Baseline to 6 weeks)
- Change in Global Clinical Improvement of Symptoms (CGI -I)(Baseline to 6 weeks)
- Change in Sheehan Disability Scale (SDS) Total Score at Endpoint(Baseline to Week 6)
- Change in Bech Melancholia Score(Baseline to 6 Weeks)
- Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score(Baseline to 6 weeks)
- Remission as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than or Equal to 12(Baseline to 6 weeks)
- Change in Total Score of Young Mania Rating Scale (YMRS)(Baseline to 6 weeks)
- Response as Measured by CGI-I Score Less Than or Equal to 2(Week 1 through Week 6 (endpoint))
- Change in Assessment of Global Clinical Severity of Symptoms (CGI-S)(Baseline to 6 weeks)
- Change in Total Score in Hamilton Depression (HAM-D 25)(Baseline to 6 Weeks)
- Change in Quality of Life, Enjoyment, and Satisfaction Scale (Q-LES-Q) Total Score at Endpoint(Baseline to 6 Weeks)
- Change in Anxiety/Somatizations Factor Total Score(Baseline to 6 Weeks)
- Change in Affective Interference Test Immediate Recall List 1 Emotional Words at Endpoint(Baseline to 6 Weeks LOCF)
- Change in Affective Interference Test, Immediate Recall, List 2 Emotional Words at Endpoint(Baseline to 6 Weeks LOCF)
- Change in Retardation Factor Scores(Baseline to 6 Weeks)
- Change in Sleep Disturbance Factor Score(Baseline to 6 weeks)
- Change in Verbal Memory Trial Performance Total Score at Endpoint(Baseline to 6 Weeks LOCF)
- Change in Affective Interference Test Immediate Recall Non-Emotional Words List 1 at Endpoint(Baseline to 6 Weeks LOCF)
- Change in Affective Interference Test, Immediate Recall, List 2 Non-Emotional Words at Endpoint(Baseline to 6 Weeks LOCF)
- Change in Affective Interference Test, Immediate Recall, List 3 Emotional Words at Endpoint(Baseline to Week 6 LOCF)
- Change in Affective Interference Test, Immediate Recall, List 3 Non-Emotional Words at Endpoint(Baseline to Week 6 LOCF)
- Change in Affective Interference Test, Immediate Recall, Cued-Recall Non-Emotional Words at Endpoint(Baseline to 6 Weeks LOCF)
- Change in Affective Interference Test, Delayed Recognition, Emotional Words False Alarms at Endpoint(Baseline to 6 Weeks LOCF)
- Change in Affective Interference Test, Immediate Recall, Cued-Recall Emotional Words at Endpoint(Baseline to 6 Weeks LOCF)
- Change in Digit Sequencing Task at Endpoint(Baseline to 6 Weeks LOCF)
- Change in Token Motor Task at Endpoint(Baseline to 6 Weeks LOCF)
- Change in Verbal Fluency in Naming Categories at Endpoint(Baseline to 6 Weeks LOCF)
- Change in Verbal Fluency Controlled Word Association at Endpoint(Baseline to 6 Weeks LOCF)
- Change in Symbol Coding at Endpoint(Baseline to 6 Weeks LOCF)
- Change in Tower of London Test at Endpoint(Baseline to 6 Weeks LOCF)
- Change in Affective Interference Test, Delayed Recognition, Emotional Words at Endpoint(Baseline to 6 Weeks LOCF)
- Change in Affective Interference Test, Delayed Recognition, Non-Emotional Words at Endpoint(Baseline to Week 6 LOCF)
- Change in Affective Interference Test, Delayed Recognition, Non-Emotional Words False Alarms at Endpoint(Baseline to Week 6 LOCF)
研究者
研究点 (1)
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