EUCTR2009-018038-12-RO进行中（未招募）1 期
A 26-week, multi-center, open-label, flexible dose, long-term safety trial of asenapine in adolescent subjects with schizophrenia - Gemini-S26
Schering-Plough Research Institute, a Division of Schering Corporation0 个研究点目标入组 204 人开始时间: 2011年1月10日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 204
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
入选标准
- •The subject must fulfill ALL the criteria listed below for entry.
- •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.
- •2. Each subject must have completed the 8-week (P05896) efficacy and safety trial, still must be younger than 18 years of age, and, according to the investigator’s judgment, would benefit from long-term treatment;
- •3. Each subject must have demonstrated an acceptable degree of compliance with trial medication, visits, and other requirements in the 8-week trial (P05896) in the opinion of the investigator;
- •4. Each subject must have a caregiver (see Section 7.6.1 of the protocol, Procedure 3) 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. The caregiver must be living with the subject and can be the subject’s parent(s) or legal representative.
- •5. Each female subject of child-bearing potential who is not currently sexually active must agree to use a medically accepted method of contraception while receiving protocol specified medication and for 1 month after stopping the medication should she become sexually active while participating in the trial.
- •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
- •The subject must fulfill ALL the criteria listed below for entry.
- •1. A female subject must not have a positive urine pregnancy test prior to dosing on Day 1, and must not have the intention to become pregnant during the course of the trial.
- •2. A subject must not be 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. A subject must not currently be under involuntary inpatient commitment.
研究者
相似试验
已完成
3 期
Flexible Dose, Long-term Safety Study of Asenapine for the Treatmentof Schizophrenia in Adolescents (P05897 AM1) (ADDRESS-97)Schizophrenia, DisorganizedSchizophrenia, UndifferentiatedHealth Condition 2: F209- Schizophrenia, unspecifiedCTRI/2012/02/002403Merck Sharp and Dohme Corp150
已完成
不适用
A 26-WEEK, MULTI-CENTER, OPEN-LABEL, FLEXIBLE DOSE, LONG-TERM SAFETY TRIAL OF ASENAPINE IN ADOLESCENT SUBJECTS WITH SCHIZOPHRENIA-F20F20PER-055-10SCHERING PLOUGH RESEARCH INSTITUTE,
进行中（未招募）
3 期
Efficacy and safety of once weekly Insulin Icodec compared to once daily Insulin Degludec100 units/mL, both in combination with Insulin Aspart, in adults with Type 1 Diabetes.CTRI/2021/08/035474ovo Nordisk ASNovo All
进行中（未招募）
1 期
Desvenlafaxine Succinate Sustained-Release (DVS SR) In The Treatment Of Children And Adolescent Outpatients With Major Depressive DisorderMajor Depressive DisorderEUCTR2008-001876-67-Outside-EU/EEAPfizer Inc.283
进行中（未招募）
不适用
urasidone extension study for the treatment of schizophrenia in paediatric patientsSchizophreniaEUCTR2013-001694-24-Outside-EU/EEASunovion Pharmaceuticals Inc.295