EUCTR2010-019778-34-LT进行中（未招募）不适用
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 IN SUBJECTS DEMONSTRATING NON-RESPONSE TO TREATMENT WITH LITHIUM OR DIVALPROEX ALONE - Prevail 3
适应症
试验速览
- 阶段
- 不适用
- 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 75 years of age inclusive, 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 (e.g., family member, caregiver, or treating health professional), 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)
- •Subjects requiring prospective run-in treatment and subjects meeting randomization criteria at the time of screening must be appropriate candidates for lithium or divalproex treatment, in the judgment of the investigator. All subjects are required to have had a minimum of 28 days of treatment with lithium or divalproex and will be required to demonstrate serum levels within the protocol-specified therapeutic range at least once during the 28 days of treatment prior to randomization.
- •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
- •Subjects 18 to 75 years of age inclusive, 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 (e.g., family member, caregiver, or treating health professional), 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)
- •Subjects requiring prospective run-in treatment and subjects meeting randomization criteria at the time of screening must be appropriate candidates for lithium or divalproex treatment, in the judgment of the investigator. All subjects are required to have had a minimum of 28 days of treatment with lithium or divalproex and will be required to demonstrate serum levels within the protocol-specified therapeutic range at least once during the 28 days of treatment prior to randomization.
- •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) monotherapy trial of three or more antidepressants administered within the package-defined therapeutic dose-range (with or without mood stabilizers) during the current episode
- •Imminent risk of suicide or injury to self, others, or property
- •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) monotherapy trial of three or more antidepressants administered within the package-defined therapeutic dose-range (with or without mood stabilizers) during the current episode
- •Imminent risk of suicide or injury to self, others, or property
研究者
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