NCT00515255终止2 期
Open-Label Exploratory Investigation Of NPL-2003 In Adolescents With Obsessive Compulsive Disorder
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Neuropharm
- 入组人数
- 6
- 试验地点
- 3
- 主要终点
- The change in OCD symptoms using CY-BOCS
研究概览
简要总结
The purpose of this study is to investigate the effect of NPL-2003 on the symptoms of Obsessive Compulsive Disorder (OCD) in an adolescent population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets DSM-IV criteria for Obsessive Compulsive Disorder.
- •CY-BOCS score of greater or equal to 16 at screening.
- •NIMH Global OC Scale score of 7 or higher at screening.
排除标准
- •Patients planning to commence cognitive behaviour therapy during the period of the study or those who have begun cognitive behaviour therapy within 8 weeks prior to enrolment.
- •Autistic Disorder or Pervasive Developmental Disorder.
- •Moderate or severe mental retardation.
- •Severe renal insufficiency.
- •Other protocol-defined Inclusion/Exclusion criteria may apply.
结局指标
主要结局
The change in OCD symptoms using CY-BOCS
时间窗: Throughout the study
次要结局
- The Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)(Throughout the study)
- NIMH Global OC Scale(Throughout the study)
- Clinical Global Impressions of Improvement (CGI-I)(Throughout the study)
- The Children's Depression Rating Scale (CDRS-R)(Throughout the study)
- Columbia Suicide-Severity Rating Scale (SSRS)(Throughout the study)
- Multidimensional Anxiety Scale for Children (MASC)(Throughout the study)
- Global Assessment Scale for Children (CGAS)(Throughout the study)
研究者
研究点 (3)
Loading locations...
相似试验
撤回
不适用
Is There a New Gold Standard for the Treatment of Obsessive-Compulsive Disorder?Obsessive-Compulsive DisorderNCT04436952University of Alberta
已完成
3 期
An Efficacy and Safety Study of CNTO1959 (Guselkumab) in the Treatment of Participants With Generalized Pustular Psoriasis or Erythrodermic PsoriasisPustular PsoriasisNCT02343744Janssen Pharmaceutical K.K.21
已完成
3 期
Long Term Open Label Study in Narcolepsy With BF2.649 (Pitolisant)NarcolepsyCataplexyNCT01399606Bioprojet102
进行中（未招募）
不适用
An Open-Label Extension of the Phase III Study CL-758010 with Alzhemed™ in Patients with Alzheimer’s Disease.Alzheimer's Disease (AD) is an irreversible, progressive neurodegenerative disorder, characterized by gradual cognitive decline, abnormal behaviour, and personality changes.MedDRA version: 9.1Level: LLTClassification code 10001896Term: Alzheimer's diseaseEUCTR2006-006490-24-SEeurochem Inc650
进行中（未招募）
不适用
An Open-Label Extension of the Phase III Study CL-758010 with Alzhemed™ in Patients with Alzheimer’s Disease.Alzheimer's Disease (AD) is an irreversible, progressive neurodegenerative disorder, characterized by gradual cognitive decline, abnormal behaviour, and personality changes.MedDRA version: 9.1Level: LLTClassification code 10001896Term: Alzheimer's diseaseEUCTR2006-006490-24-FReurochem Inc650