NCT00312494已完成3 期
A Three-Week, Double-Blind, Multicenter, Placebo-Controlled Study Evaluating the Efficacy and Safety of Add-On Oral Ziprasidone in Subjects With Acute Mania Treated With Lithium or Divalproex
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 680 人开始时间: 2006年4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
- 680
- 试验地点
- 1
- 主要终点
- Change From Baseline to Week 3 in Young Mania Rating Scale (YMRS)
研究概览
简要总结
3-week study to evaluate efficacy and safety of ziprasidone with either lithium or divalproex in acutely manic subjects
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Subjects must have a primary diagnosis of Bipolar I Disorder, most recent episode manic (296.4x), or mixed (296.6x) as defined in Diagnostic and Statistical Manual of Mental Disorders - Text Revision (DSM-IV TR) and determined by the Mini International Neuropsychiatric Interview (MINI).
- •At screening and at baseline (within 12 hours prior to the first dose of double-blind medication) subjects must have a Young Mania Rating Scale score of 18 or higher.
- •Subjects must be actively receiving lithium or divalproex for their bipolar disorder in order to be considered for this study.
排除标准
- •Subjects with a Diagnostic and Statistical Manual of Mental Disorders IV- Text Revision (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 (NOS) (298.9).
- •Subjects with other DSM-IV-TR Axis I or Axis II disorders (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
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Ziprasidone 20-40mg twice a day (BID)
Experimental
干预措施: Ziprasidone (Drug)
Ziprasidone 60-80mg BID
Experimental
干预措施: Ziprasidone (Drug)
结局指标
主要结局
Change From Baseline to Week 3 in Young Mania Rating Scale (YMRS)
时间窗: Baseline, Week 3
YMRS is an 11-item scale (elevated mood, increased motor activity-energy, sexual interest, sleep, irritability, speech \[rate and amount\], language-thought disorder, content, disruptive-aggressive behavior, appearance, and insight) used to assess the severity of manic symptoms and effect of treatment on mania severity. Seven items ranked on scale from 0 to 4; 4 items ranked 0 to 8. Total possible score 0 to 60: higher scores indicate greater severity. Change calculated as mean of (value of YMRS score at observation minus baseline value).
次要结局
- Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Score(Baseline, Week 3)
- Change From Baseline in Clinical Global Impression Scale - Severity (CGI-S) Score(Baseline, Week 1, Week 2, Week 3)
- Change From Baseline in Longitudinal Interval Follow-up Evaluation Range of Impaired Functioning (LIFE-RIFT) Score(Baseline, Week 3)
- Change From Baseline to Week 1 and Week 2 in YMRS(Baseline, Week 1, Week 2)
- Clinical Global Impression - Improvement (CGI-I) Scale Scores(Week 1, Week 2, Week 3)
- Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Scores(Baseline, Week 1, Week 2, Week 3)
- Change From Baseline in Global Assessment of Functioning (GAF) Score(Baseline, Week 3)
- Anonymized Pharmacogenomic Blood Draw(Baseline)
研究者
研究点 (1)
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