NCT00730249已完成3 期
Quality Assurance of Administering Methylphenidate in Adults With ADHD
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 11
- 主要终点
- Wender-Reimherr Adult Attention Deficit Disorder Scale (WRAADDS) in last study-week (Placebo vs. Verum, double-blind phase, week 6)
研究概览
简要总结
Investigation of efficacy of high-dose extended-release Methylphenidate in adults with ADHD, compared with a placebo
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient treated as out-patient
- •score of 85 or greater in IQ-test (MWT-B)
- •diagnosis of ADHD according ADHS-CL (DSM IV) and WRAADDS > 35 points
- •ADHD symptoms have existed since childhood (WURS-k >= 30)
- •Body Mass Index >= 20 and body weight < 130 kg
- •willing to eat breakfast and lunch
- •patient is willing and able to come to the observation appointments
- •written consent of the patient to participate in the study
排除标准
- •treatment with psychostimulants in the past two weeks before screening
- •shift work or night work
- •alcohol, medication or drug dependency in the past six months or manifest drug abuse
- •diagnosis of a psychosis (SKID-I)
- •epileptic attacks in the past
- •EEG result which suggests epilepsy
- •acute depressive episode according to ICD-10 F32.2 and ICD-10 F32.3 (Beck-Depression-Inventory > 18)
- •Illness with schizophrenic symptoms (SKID-I)
- •acute manic episode, bipolar disorder(SKID-I)
- •diagnosis of a tic disorder
- •acute anorexia
- •acute prominent panic disorder and generalised anxiety (SKID-I)
- •clinically relevant kidney disorders
- •creatinine > 1,5 x upper norm-range
- •clinically relevant liver disorder
- •SGOT and/or SGPT > 2 x upper norm-range
- •pathological ECG-finding
- •QTc > 450 msec in male, QTc > 470 msec in female
- •high blood pressure (anamnesis or blood pressure > 140/90 mm Hg at screening)
- •known acclusive arterial disease
- •angina pectoris (anamnesis or ECG-finding)
- •cardiac arrhythmias (anamnesis or ECG-finding)
- •KHK (anamnesis or ECG-finding)
- •post heart-attack status (anamnesis or ECG-finding)
- •post stroke status
- •known elevated intra-ocular pressure
- •known enlarged prostates
- •latent and manifest hyperthyreosis
- •TSH < lower norm-range
- •patient with a terminal disease (e.g. cancer)
- •participation in a clinical study within the past 30 days
- •participation in this study at an earlier point in time
- •simultaneous participation in another clinical trial
- •women of child-bearing age without adequate contraception (contraceptives, intrauterine device , no sexual intercourse)
- •pregnancy (positive pregnancy test) or lactation period
研究组 & 干预措施
2
Placebo Comparator
干预措施: Placebo (Drug)
1
Active Comparator
干预措施: methylphenidate hydrochloride (Drug)
结局指标
主要结局
Wender-Reimherr Adult Attention Deficit Disorder Scale (WRAADDS) in last study-week (Placebo vs. Verum, double-blind phase, week 6)
时间窗: 20 weeks
次要结局
- CAARS-Self-Report: Long Version (CAARS-S:L)(20 weeks)
研究者
研究点 (11)
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