EUCTR2012-001935-30-CZ进行中（未招募）不适用
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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
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 1. Excursions are defined as Y-MRS or MADRS scores >12 but = 16.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 380
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
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.
- •-Has a history of rapid cycling BPD I with = 8 cycles within the last year.
- •-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
研究者
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