EUCTR2008-007482-23-CZ进行中（未招募）1 期
A Randomized, 6-Week, Double-Blind, Placebo-Controlled, Flexible-Dose, Parallel-Group Study of Lurasidone Adjunctive to Lithium or Divalproex for the Treatment of Bipolar I Depression
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 340
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
- •- Subjects 18 to 65 years of age, with bipolar I disorder, most recent episode depressed with or without rapid cycling disease course (= 4 episodes of mood disturbance but < 8 episodes in the previous 12 months) and without psychotic features (diagnosed by DSM-IV-TR criteria, and confirmed by the MINI). The current episode of major depression associated with bipolar I disorder must be confirmed by the investigator and noted in the source records.
- •- Subjects must have a lifetime history of at least one bipolar manic or mixed manic episode. It is strongly recommended that a reliable informant (eg, family member or caregiver) be available to confirm this history
- •- Subject’s current major depressive episode is = 4 weeks and less than 12 months in duration
- •- MADRS total score = 20 (at both screening and baseline visits)
- •- YMRS total score = 12 (at both screening and baseline visits)
- •- Lithium or divalproex levels must be within the protocol-defined therapeutic range (0.6-1.2 mEq/L for lithium or 50-125 µg/mL for divalproex) at screening. Although the lower limit for lithium serum concentration is 0.6 mEq/L at screening and during the study, lithium levels = 0.4 mEq/L will be permitted with Medical Monitor approval if 0.6 mEq/L or higher is judged to be intolerable or unsafe for an individual subject. The investigator will verify that the subject has had continuous treatment with either medication for a minimum of 28 days prior to the screening visit based on confirmation from a reliable informant (eg, family member or other caregiver) or treating health professional. All preparations of lithium, divalproex (including extended-release formulations), or valproic acid will be permitted.
- •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 340
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 340
排除标准
- •- Diagnosis of an Axis I or Axis II disorder, other than bipolar I disorder, that is the primary focus of treatment within 3 months prior to screening
- •- Subject scores = 4 on MADRS item number 10 (suicidal thoughts) at screening or baseline
- •- History of non-response to an adequate (6-week) trial of three or more antidepressants (with or without mood stabilizers) during the current episode
- •- Imminent risk of suicide or injury to self, others, or property
- •- Subject has been hospitalized for a manic or mixed episode within the 60 days prior to randomization
研究者
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