NCT01737268已完成3 期
Long-term Study of FK949E in Elderly Patients -Long-term Study in Elderly 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
- 20
- 试验地点
- 32
- 主要终点
- Change From Baseline to Last Assessment in Treatment Period in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
研究概览
简要总结
FK949E was administered to elderly bipolar disorder patients with major depressive episode for 52 weeks. Its safety, efficacy, and plasma concentration change were evaluated in an open-label manner.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older 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
- •Male subjects must agree to take appropriate contraceptive measures with condoms during the study period.
- •Female subjects must be confirmed to have no childbearing potential during the study period
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 was 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 more than 12 months or 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 primary registration.
- •Unable to suspend antipsychotics or antidepressants after primary registration
- •Treatment with two or more of mood stabilizers (lithium carbonate and/or sodium valproate) and lamotrigine, if these drugs, except one of either drug, cannot be suspended after primary registration.
- •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 primary registration
- •Electroconvulsive therapy within the last 83 days before primary registration.
- •A possible need of psychotherapy during the study period (unless the therapy has been commenced at least 83 days before primary registration).
- •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 Elderly Participants
Experimental
After 2 days of dose-titration, elderly participants received either FK949E 150 mg or FK949E 300 mg once daily at bedtime from day 3 to week 52. Dose increase and reduction was allowed following dose increase or reduction guidelines and at the investigator's discretion. After which, participants went through a follow-up period of 1 week. For participants, who completed or discontinued treatment at FK949E 300 mg, a dose-tapering period was placed before proceeding to the follow-up period, and FK949E 150 mg was administered once daily for 1 week in this period.
干预措施: FK949E (Drug)
结局指标
主要结局
Change From Baseline to Last Assessment in Treatment Period in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
时间窗: Baseline and week 52 (or the time of last assessment for participants who discontinued earlier)
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
- Change From Baseline to Last Assessment in Treatment Period in Hamilton Depression Scale (HAM-D17)(Baseline and week 52 (or the time of last assessment for participants who discontinued earlier))
- Change From Baseline to Last Assessment in Treatment Period in CGI-BP-S: Depression(Baseline and week 52 (or the time of last assessment for participants who discontinued earlier))
- Change From Baseline to Last Assessment in Treatment Period in CGI-BP-S: Mania(Baseline and and week 52 (or the time of last assessment for participants who discontinued earlier))
- Change From Baseline to Last Assessment in Treatment Period in Clinical Global Impression-Bipolar-Severity of Illness (CGI-BP-S): Overall Bipolar Illness(Baseline and week 52 (or the time of last assessment for participants who discontinued earlier))
- Clinical Global Impression-Bipolar-Change (CGI-BP-C): Overall Bipolar Illness(Week 52 (or the time of last assessment for participants who discontinued earlier))
- CGI-BP-C: Depression(Week 52 (or the time of last assessment for participants who discontinued earlier))
- CGI-BP-C: Mania(Week 52 (or the time of last assessment for participants who discontinued earlier))
- Number of Participants With Adverse Events(From first dose of study drug up to week 52 (52 weeks))
研究者
研究点 (32)
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