EUCTR2010-022648-19-Outside-EU/EEA进行中（未招募）不适用
A 26-Week Open-Label, Flexible-Dose Trial of Asenapine Extension Treatment to P06107 in Pediatric Acute Manic or Mixed episodes Associated With Bipolar I Disorder - ADDRESS-98
Schering-Plough Research Institute, a Division of Schering Corporation0 个研究点目标入组 350 人开始时间: 2011年11月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 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
- •1. Each subject’s parent(s) or legal representative must be willing and able to provide written informed consent for the trial and each subject must indicate assent before trial participation;
- •2. Each subject must have completed the 3-week (P06107) efficacy and safety trial and, according to the investigator’s judgment, may benefit from long-term treatment;
- •3. Each subject must have demonstrated an acceptable degree of compliance with trial medication, visits, and other requirements in trial P06107 in the opinion of the investigator;
- •4. Each subject must be =12 years and =18 years of age; A subject may be of either sex, and of any race/ethnicity;
- •5. Each subject must be a male, or a female who is not of childbearing potential (eg, surgically sterile) or who is non-pregnant, non-lactating, and is using a medically accepted method of contraception. If a female subject of childbearing potential, must agree to use a medically
- •accepted method of contraception while receiving protocol specified medication and for 1 month after stopping the medication;
- •6. Each subject must have a caregiver, or an identified responsible person, living with the subject, who is considered reliable by the investigator and who has agreed to provide support to the subject to ensure compliance with trial treatment, outpatient visits, and protocol procedures;
- •Refer to protocol for complete list
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •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
- •1. The subject has a positive urine pregnancy test at Baseline, or the intention to become pregnant during the course of the trial;
- •2. The subject is at imminent risk of self-harm or harm to others, in the investigator’s opinion based on clinical interview and responses provided on the Columbia Suicide Severity Rating Scale (C-SSRS);
- •3. The subject is under involuntary inpatient commitment;
- •4. A subject has known serological evidence of human immunodeficiencyvirus (HIV) antibody.
研究者
相似试验
已完成
3 期
Extension Study of Asenapine [P06107 (NCT01244815)] for Pediatric Bipolar Disorder (P05898)Bipolar DisorderNCT01349907Organon and Co322
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Efficacy and safety of asenapine treatment for pediatric bipolar disorderAcute Manic or Mixed Episodes Associated with Bipolar I DisorderMedDRA version: 14.0Level: LLTClassification code 10068455Term: Bipolar I disorder, hypomanicSystem Organ Class: 10037175 - Psychiatric disordersEUCTR2010-022647-38-Outside-EU/EEASchering-Plough Research Institute, a Division of Schering Corporation400
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