A Six-Week, Double-Blind, Multicenter, Placebo Controlled Study Evaluating The Efficacy And Safety Of Flexible Doses Of Oral Ziprasidone As Add-On, Adjunctive Therapy With Lithium, Valproate Or Lamotrigine In Bipolar I Depression
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 298
- 试验地点
- 1
- 主要终点
- Change From Baseline to Week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
研究概览
简要总结
The purpose of this study is to determine if a treatment regimen of ziprasidone plus a mood stabilizer is safe and effective in the short term treatment of Bipolar I Depression. Ziprasidone will be added to lithium, valproate or lamotrigine after the patient has been on a therapeutic dose of one of these mood stabilizers for at least 4 weeks.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for Bipolar I disorder, most recent episode depressed, with or without rapid cycling and without psychotic features. Subjects receive therapeutic dose of lithium, valproate or lamotrigine for at least 4 weeks prior to randomization.
排除标准
- •Patients with ultra-fast rapid cycling (8 or more mood episodes per year)
- •Significant heart disease including abnormalities in the heart's rhythm (QT prolongation)
- •Psychotic symptoms (hallucinations and/or delusions).
研究组 & 干预措施
Ziprasidone
Active treatment, double-blind, randomized treatment arm
干预措施: Ziprasidone (Drug)
Placebo
Inactive, placebo treatment, double-blind, randomized arm
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline to Week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
时间窗: Baseline, Week 6
MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thoughts); rated on a 7-point Likert scale 0 (normal) to 6 (most abnormal); total score 0 to 44 (higher score indicates greater severity of symptoms). Change calculated as a difference between post-baseline observation and baseline MADRS score values.
次要结局
- MADRS Remission: Number of Subjects With Total MADRS Score ≤ 12 at Week 6(Week 6)
- Change From Baseline in CGI-Severity Score (Post-baseline Excluding Week 6)(Baseline, Week 1, Week 2, Week 3, Week 4, Week 5)
- MADRS Response: Number of Subjects With Total MADRS Score Reduction ≥ 50 Percent From Baseline at Week 6(Week 6)
- Clinical Global Impression - Improvement Scale (CGI-Improvement or CGI-I): Number of Subjects With Response (Much Improved or Very Much Improved) at Week 6(Baseline, Week 6)
- Change From Baseline in MADRS Total Score (Post-baseline Excluding Week 6)(Baseline, Week 1, Week 2, Week 3, Week 4, Week 5)
- CGI-Improvement Score(Week 1, Week 2, Week 3, Week 4, Week 5, Week 6)
- Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score(Baseline, Week 2, Week 4, Week 6)
- Change From Baseline in Young Mania Rating Scale (YMRS) Total Score(Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6)
- Change From Baseline in Global Assessment of Functioning (GAF) Scale at Week 6(Baseline, Week 6)
- Change From Baseline to Week 6 in Clinical Global Impression - Severity Scale (CGI-Severity or CGI-S)(Baseline, Week 6)
- Change From Baseline in Sheehan Disability Scale (SDS) at Week 6 (Items 1 Through 3)(Baseline, Week 6)
- Change From Baseline in Sheehan Disability Scale (SDS) at Week 6 (Items 4 and 5)(Baseline, Week 6)
- Change From Baseline in Quality of Life, Enjoyment, and Satisfaction Scale (Q-LES-Q) Scores at Week 6(Baseline, Week 6)