NCT01674010终止2 期
A Prospective, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Safety and Efficacy Study of Oral ELND005 as an Adjunctive Maintenance Treatment in Patients With Bipolar I Disorder
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 309
- 试验地点
- 1
- 主要终点
- Treatment Emergent Adverse Events
研究概览
简要总结
The primary purpose of this study is to determine whether ELND005 is effective in the maintenance treatment of bipolar 1 disorder when added to other therapies.
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
- •Meets the DSM-IV-TR criteria for BPD I by the SCID, prior to the Screening Visit.
- •Has a history in the last 3 years of ≥ 1 manic or mixed episodes of sufficient severity that required hospitalization and/or treatment with a mood stabilizer or antipsychotic, or confirmed by a family member or medical records to ensure the episode fulfills the DSM-IV-TR criteria.
- •Has experienced a mood episode of any polarity within 4 months prior to the Screening Visit and responded to StOC therapy.
- •Is euthymic at the Screening Visit (ie, score of ≤ 12 on the MADRS and a score of ≤ 12 on the Y-MRS).
- •Is receiving maintenance treatment for his or her BPD I with either LTG or VPA; on stable doses for past 4 weeks and therapeutic drug levels (total VPA 50--125 µg/mL and LTG 10-50 µmol/L or as deemed appropriate by the investigator). Dose adjustments made for tolerability reasons will be acceptable.
- •A study patient must meet the following additional criteria to be eligible for randomization in the Double-blind Randomization Phase of this study:
- •Maintained in a stable euthymic state during Phase 1, defined as Y-MRS and MADRS scores of ≤ 12, with the following exceptions: a maximum of 2 nonconsecutive excursions will be allowed throughout Phase
- •Excursions are defined as Y-MRS or MADRS scores >12 but ≤ 16.
排除标准
- •Woman of childbearing potential who is unwilling or unable to use an acceptable method of birth control or is using a prohibited contraceptive method.
- •Is found to be actively suicidal on the C-SSRS (answer of "yes" to question 4 or 5 [current or over the last 30 days]) or a score of ≥4 on the MADRS item 10 at the Screening Visit.
- •Has suboptimally treated thyroid disease as evidenced by thyroid-stimulating hormone (TSH) >3 mIU/L at the Screening Visit.
- •Has received electroconvulsive therapy (ECT) during the current episode or within 6 months prior to the Screening Visit.
- •Has an estimated glomerular filtration rate <40 mL/min/1.73 m2 according to the Modification of Diet in Renal Disease formula.
- •A study patient who meets ANY of the above and ANY of the criteria below will not be eligible for enrollment in the Double-blind Randomization Phase of this study:
- •Has current signs or symptoms of psychosis.
- •Has become actively suicidal as defined by C-SSRS answer of "yes" to question 4 or 5 (current or over the last 30 days) and/or has a score of ≥4 on MADRS item 10.
研究组 & 干预措施
Lamotrigine or Valproic acid + ELND005
Experimental
Lamotrigine or valproic acid plus ELND005 film coated tablets, 500mg BID for up to 48 weeks
干预措施: ELND005 (Drug)
Lamotrigine or Valproic acid + ELND005
Experimental
Lamotrigine or valproic acid plus ELND005 film coated tablets, 500mg BID for up to 48 weeks
干预措施: Lamotrigine (Drug)
Lamotrigine or Valproic acid + ELND005
Experimental
Lamotrigine or valproic acid plus ELND005 film coated tablets, 500mg BID for up to 48 weeks
干预措施: Valproic acid (Drug)
Lamotrigine or Valproic acid + placebo
Placebo Comparator
Lamotrigine or valproic acid plus matched placebo BID for up to 48 weeks
干预措施: Lamotrigine (Drug)
Lamotrigine or Valproic acid + placebo
Placebo Comparator
Lamotrigine or valproic acid plus matched placebo BID for up to 48 weeks
干预措施: Valproic acid (Drug)
Lamotrigine or Valproic acid + placebo
Placebo Comparator
Lamotrigine or valproic acid plus matched placebo BID for up to 48 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Treatment Emergent Adverse Events
时间窗: up to 48 weeks
The study was terminated early so no efficacy analysis was done, safety data are reported.
次要结局
- Proportion of Study Participants With Recurrence of Any Mood Episode(up to 48 weeks)
- Time to Recurrence of a Depressive Episode(up to 48 weeks)
- Time to Recurrence of a Manic/Hypomanic or a Mixed Episode(up to 48 weeks)
研究者
研究点 (1)
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