NCT02362412已完成3 期
Study of FK949E - An Open-label, Two-way Crossover Study to Evaluate the Effects of Switching Different Strength Forms of FK949E in Bipolar Disorder Patients With Major Depressive Episodes
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 22
- 主要终点
- Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
研究概览
简要总结
The purpose of this study was to evaluate the efficacy, safety, and pharmacokinetics of switching FK949E (sustained-release quetiapine) 50-mg and 150-mg tablets to the other tablet at the equivalent total daily dose in bipolar disorder patients with major depressive episodes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of bipolar I or II disorder as specified in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR), with a major depressive episode.
- •Able to participate in the study with understanding of and compliance with subject requirements during the study in the investigator's or subinvestigator's opinion.
排除标准
- •Concurrent or previous history of DSM-IV-TR Axis I disorders, except bipolar disorder, within the last 6 months before informed consent.
- •Concurrence of DSM-IV-TR Axis II disorder that is considered to greatly affect patient's current mental status.
- •The Young Mania Rating Scale (YMRS) total score of 13 points or more.
- •Nine or more mood episodes within the last 12 months before informed consent.
- •Lack of response to at least 6-week treatment with at least 2 antidepressants for the current major depressive episode in the investigator's or subinvestigator's opinion.
- •The current major depressive episode persisting for less than 4 weeks before informed consent.
- •History of substance dependence (other than caffeine and nicotine) or alcohol abuse or dependence.
- •Treatment with a depot antipsychotic within the last 49 days before the start of the pre-treatment observation period.
- •Unable to suspend antipsychotics or antidepressants after the start of the pre-treatment observation period.
- •Treatment with more than one of the following three drugs, mood stabilizers (lithium carbonate and/or sodium valproate) and lamotrigine, if these drugs, except one of either drugs, cannot be suspended after the start of the pre-treatment observation period.
- •Unable to suspend antiepileptics (except lamotrigine and sodium valproate), antianxiety agents, hypnotics, sedatives, psychostimulants, antiparkinsonian agents, cerebral ameliorators, antidementia agents, or anorectics, except those specified as conditionally-allowed concomitant drugs, from 7 days before the start of the pre-treatment observation period.
- •Unable to suspend CYP3A4 inhibitors or inducers, or monoamine oxidase (MAO) inhibitors from 7 days before the start of the pre-treatment observation period.
- •Electroconvulsive therapy within the last 83 days before the start of the pre-treatment observation period.
- •A possible need of psychotherapy during the study period (unless the therapy has been commenced at least 83 days before the start of the pre-treatment observation period).
- •The Hamilton Depression Rating Scale (HAM-D17) suicide score of 3 points or more, history of suicide attempt within the last 6 months before informed consent, or the risk of suicide in the investigator's or subinvestigator's opinion.
研究组 & 干预措施
FK949E 50 MG / FK949E 150 MG
Experimental
Participants who received the 50 mg tablet once daily during Treatment Period II (8 weeks) and 150 mg tablet once daily during Treatment Period III (8 weeks).
干预措施: FK949E (Drug)
FK949E 150 MG / FK949E 50 MG
Experimental
Participants who received the 150 mg tablet once daily during Treatment Period II (8 weeks) and 50 mg tablet once daily during Treatment Period III (8 weeks).
干预措施: FK949E (Drug)
结局指标
主要结局
Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
时间窗: Week 8 of each treatment period (Week 12 and Week 20)
The MADRS is a 10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms.
次要结局
- Clinical Global Impression-Bipolar-Severity of Illness (CGI-BP-S): Overall Bipolar Illness(Week 8 of each treatment period (Week 12 and Week 20))
- Hamilton Depression Scale (HAM-D17)(Week 8 of each treatment period (Week 12 and Week 20))
- Clinical Global Impression-Bipolar-Change (CGI-BP-C):Depression(Week 8 of each treatment period (Week 12 and Week 20))
- Clinical Global Impression-Bipolar-Severity of Illness (CGI-BP-S):Depression(Week 8 of each treatment period (Week 12 and Week 20))
- Clinical Global Impression-Bipolar-Severity of Illness (CGI-BP-S): Mania(Week 8 of each treatment period (Week 12 and Week 20))
- Clinical Global Impression-Bipolar-Change (CGI-BP-C):Overall Bipolar Illness(Week 8 of each treatment period (Week 12 and Week 20))
- Clinical Global Impression-Bipolar-Change (CGI-BP-C):Mania(Week 8 of each treatment period (Week 12 and Week 20))
- Number of Participants With Adverse Events(Up to 22 weeks)
研究者
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