NCT00467428已完成2 期
Efficacy and Safety of NS2359 in Adults With Attention Deficit Hyperactivity Disorder. A Randomised, Double-Blind, Placebo-Controlled Study
NeuroSearch A/S2 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2003年8月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- To investigate the efficacy of NS2359 in adult patients diagnosed with ADHD (predominantly inattentive, predominantly hyperactive/impulsive or combined) according to DSM-IV criteria.
研究概览
简要总结
The purpose of the study is to investigate if NS2359 is effective in the treatment of ADHD in adult patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with the diagnosis of Attention Deficit Hyperactivity Disorder (ADHD), by DSM-IV, as manifested in clinical evaluation and confirmed by structured interview using the K-SADS-E adult ADHD module
- •Patients with a CGI Global Severity (GS) score ≥4 (moderate impairment)
- •The Patient provided written informed consent.
- •Non-lactating women of childbearing potential that used adequate contraception (i.e. the use of oral contraceptives and practising a double-barrier form of birth control) and had a negative pregnancy test at screening. Women of no childbearing potential who had been postmenopausal for less than 2 years must have a negative pregnancy test at screening.
排除标准
- •Any clinically unstable medical condition
- •Clinically significant abnormal baseline laboratory values
- •Mental retardation
- •Organic brain disorders
- •Non-febrile seizure disorder
- •Patients with a history of an eating disorder including anorexia or bulimia nervosa
- •Psychotic disorder of any type
- •Patients with a HAM-D (17 item) >15
- •Patients currently (within the past 6 months) known to abuse or to be dependent on any drug, including alcohol or a positive urine drug screen for cocaine, heroin, or marijuana
- •Treatment with stimulants was prohibited within 1 week prior to randomisation
- •Treatment with antipsychotics/neuroleptics was prohibited for 8 weeks prior to randomisation
- •Treatment with monoamine oxidase inhibitors was prohibited for 8 weeks prior to randomisation
- •Treatment with tricyclic antidepressants, histamines and selective serotonin reuptake inhibitors was prohibited for 4 weeks (fluoxetine for 6 weeks) prior to randomisation
- •Treatment with benzodiazepines, anticonvulsants (for behaviour) and lithium for 2 weeks prior to randomisation
- •Patients with a history of bipolar disorder
- •Patients using any concurrent medication for the treatment of ADHD
- •Patients that had previously participated in a NS2359 study
- •Patients treated with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication
- •Patients with a history of positive human immunodeficiency virus (HIV) test.
结局指标
主要结局
To investigate the efficacy of NS2359 in adult patients diagnosed with ADHD (predominantly inattentive, predominantly hyperactive/impulsive or combined) according to DSM-IV criteria.
次要结局
- To investigate the safety and tolerability of NS2359 in adult ADHD patients.
研究者
研究点 (2)
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