PER-055-10已完成未知
A 26-WEEK, MULTI-CENTER, OPEN-LABEL, FLEXIBLE DOSE, LONG-TERM SAFETY TRIAL OF ASENAPINE IN ADOLESCENT SUBJECTS WITH SCHIZOPHRENIA
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 14 至 18(—)
- 性别
- All
入选标准
- •Each participant must be between 12 and 17 years of age at the time of entry on this study, however, participants in the 8-week base study (P05896 [NCT01190254]) who reach 18 years of age while on P05896 may be enrolled in this extension study provided all other inclusion/exclusion criteria are met.
- •Must have completed the 8-week efficacy and safety trial (P05896 [NCT01190254]) and, according to the investigator´s judgment, would benefit from long-term treatment.
- •Must have demonstrated an acceptable degree of compliance with trial medication, visits, and other requirements in the 8-week trial (P05896 [NCT01190254]), in the opinion of the investigator.
排除标准
- •A female participant must not be pregnant and must not have the intention to become pregnant during the trial.
- •A participant must not be at imminent risk of self-harm or harm to others.
- •A participant must not currently be under involuntary inpatient commitment.
研究者
相似试验
进行中(未招募)
不适用
Study Evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) In The Treatment Of Children And Adolescent Outpatients With Major Depressive DisorderMajor Depressive DisorderEUCTR2008-002064-34-Outside-EU/EEAPfizer Inc.269
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-S26SchizophreniaEUCTR2009-018038-12-ROSchering-Plough Research Institute, a Division of Schering Corporation204
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
进行中(未招募)
1 期
A 104-WEEK, FLEXIBLE-DOSE, OPEN-LABEL, MULTICENTER, EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFECTIVENESS OF LURASIDONE IN PEDIATRIC SUBJECTSExtension study for the D1050301 Adolescent Schizophrenia study, the D1050325 Children and Adolescent autistic disorder and the D1050326 Children and Adolescent Bioplar I DepressionMedDRA version: 18.0Level: LLTClassification code 10004936Term: Bipolar depressionSystem Organ Class: 10037175 - Psychiatric disordersMedDRA version: 18.0Level: HLGTClassification code 10039628Term: Schizophrenia and other psychotic disordersSystem Organ Class: 10037175 - Psychiatric disordersMedDRA version: 18.0Level: LLTClassification code 10003808Term: Autistic disorderSystem Organ Class: 100000004852EUCTR2013-001694-24-FRSUNOVION PHARMACEUTICALS INC.574
进行中(未招募)
1 期
A 104-WEEK, FLEXIBLE-DOSE, OPEN-LABEL, MULTICENTER, EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFECTIVENESS OF LURASIDONE IN PEDIATRIC SUBJECTS WITH SCHIZOPHRENIA AND SUBJECTS WITH IRRITABILITY ASSOCIATED WITH AUTISTIC DISORDERSCHIZOPHRENIA AND IRRITABILITY ASSOCIATED WITH AUTISTIC DISORDERMedDRA version: 14.1 Level: HLGT Classification code 10039628 Term: Schizophrenia and other psychotic disorders System Organ Class: 10037175 - Psychiatric disordersEUCTR2013-001694-24-ESSUNOVION PHARMACEUTICALS INC.701
