EUCTR2013-004903-37-HU进行中（未招募）1 期
A RANDOMIZED, 6-WEEK, DOUBLE-BLIND, PLACEBO-CONTROLLED, FLEXIBLE DOSE, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF LURASIDONE IN CHILDREN AND ADOLESCENT SUBJECTS WITH BIPOLAR I DEPRESSIO
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 350
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
- •Male or female subjects 10 to 17 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-V criteria, and confirmation of the bipolar I disorder diagnosis by an adequately trained clinician at the time of screening, by means of the Schedule for Affective Disorders and Schizophrenia for School-age Children [K-SADS-PL]). Children's Depression Rating Scale, Revised (CDRS-R) total score = 45 at screening and Baseline. Young Mania Rating Scale (YMRS) score = 15 (with YMRS Item 1 [elevated mood] score = 2) at screening and Baseline.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 340
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Has an Axis I or Axis II diagnosis other than bipolar I disorder and/or concomitant ADHD that has been the primary focus of treatment within 3 months of screening. Has a history or current diagnosis of intellectual disability, Autism Spectrum Disorder, neuroleptic malignant syndrome, or any neurologic disorder, severe head trauma, or any unstable medical condition. CDRS-R total score > 85 at screening or Baseline.
研究者
相似试验
进行中（未招募）
不适用
A 6-WEEK STUDY OF LURASIDONE ADJUNCTIVE TO LITHIUM ORDIVALPROEX FOR THE TREATMENT OF BIPOLARDEPRESSION IN SUBJECTS NOT RESPONDING TO TREATMENT WITH LITHIUM OR DIVALPROEX ALONEBipolar disorderEUCTR2010-019778-34-LTSunovion Pharmaceuticals Inc.340
进行中（未招募）
不适用
The purpose of this research study is to evaluate the safety and effectiveness of lurasidone (20 mg/day to 80 mg/day) compared to a placebo for use in children and adolescent subjects with bipolar I depression.Bipolar I depressionMedDRA version: 16.1Level: LLTClassification code 10004936Term: Bipolar depressionSystem Organ Class: 100000004873EUCTR2013-004903-37-ITSUNOVION PHARMACEUTICALS INC.340
进行中（未招募）
1 期
The purpose of this research study is to evaluate the safety and effectiveness of lurasidone (20 mg/day to 80 mg/day) compared to a placebo for use in children and adolescent subjects with bipolar I depression.Bipolar I depressionMedDRA version: 17.1Level: LLTClassification code 10004936Term: Bipolar depressionSystem Organ Class: 100000004873EUCTR2013-004903-37-DESUNOVION PHARMACEUTICALS INC.340
进行中（未招募）
不适用
A 6-WEEK STUDY OF LURASIDONE ADJUNCTIVE TO LITHIUM ORDIVALPROEX FOR THE TREATMENT OF BIPOLAR DEPRESSION IN SUBJECTS NOT RESPONDING TO TREATMENT WITH LITHIUM OR DIVALPROEX ALONEMedDRA version: 14.1Level: LLTClassification code 10004936Term: Bipolar depressionSystem Organ Class: 10037175 - Psychiatric disordersBipolar disorderEUCTR2010-019778-34-CZSunovion Pharmaceuticals Inc.340
进行中（未招募）
1 期
The purpose of this research study is to evaluate the safety and effectiveness of lurasidone (20 mg/day to 80 mg/day) compared to a placebo for use in children and adolescent subjects with bipolar I depression.Bipolar I depressionMedDRA version: 17.0Level: LLTClassification code 10004936Term: Bipolar depressionSystem Organ Class: 100000004873EUCTR2013-004903-37-GBSUNOVION PHARMACEUTICALS INC.350