ISRCTN93724387已完成4 期
Effect of methylphenidate formulation on attention deficit hyperactivity disorder (ADHD)-patients' adherence to medical treatment. A comparison of Medikinet retard® (extended-release [ER]) once daily and Medikinet® (immediate-release [IR]) twice daily in children and adolescents diagnosed with ADHD: a prospective open-label randomised active-controlled multi-centre trial
Johannes Gutenberg University of Mainz (Germany)0 个研究点目标入组 106 人开始时间: 2009年4月30日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 106
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
- 性别
- All
入选标准
- •Subjects meeting all of the following criteria are considered for enrolment into the trial:
- •1. Written informed consent (separately for children aged 6-11 years and 12-17 years)
- •2. Children and adolescents of both sexes aged 6 - 17 years
- •3. Confirmed diagnosis of ADHD by semi structured-clinical interview (K-SADS)
- •4. The ADHD Rating Scale-IV (ADHDRS-IV) Parent Version (18-Item-Scale) raw score >=1.5 SD above norm under non-medicated conditions (either drug holiday or prior to medication within the past 6 months)
- •5. Effective treatment with a stable dose of methylphenidate for at least one month (max. 60 mg/day) proved by a 25% symptom reduction in ADHD Rating Scale (ADHD-RS) under medication, compared to retrospective ADHD-RS without medication within the past 6 months
- •6. Acceptance and capability to swallow capsules of product size, proved by an equally sized placebo provided by Medice®
- •7. Sufficient knowledge of the German language
- •8. Adequate contraception in case of sexual activity
排除标准
- •Subjects fulfilling any of the following criteria will not be enrolled into the trial:
- •1. Contraindications against methylphenidate
- •1.1. Allergy or hypersensitivity against methylphenidate or methylphenidate derivate or any other ingredient of the product
- •1.2. Severe anxiety disorder, high tenseness or arousal, depression, psychosis
- •1.3. Hyperthyroidism
- •1.4. Glaucoma
- •1.5. Thyreotoxicosis
- •1.6. Severe angina pectoris
- •1.7. Cardiac arrhythmia
- •1.8. Severe hypertension
- •1.9. Heart insufficiency
- •1.10. Myocardial infarction
- •1.11. Known substance abuse or alcoholism
- •1.12. Intake of Monoamine oxidase (MAO) inhibitor at the same time or during the last 14 days
- •1.13. Tic-disorder or tic disorder in family history
- •1.14. Pregnancy, lactation
- •1.15. Marked gastric anacidity
- •2. Previous stable methylphenidate intake more than twice daily
- •3. All severe psychiatric disorders except oppositional defiant disorder (ODD) or conduct disorder. In order to reflect the usual co-morbid spectrum of ADHD, mild or moderate anxiety or depressive disorders are accepted in the study.
- •4. All severe somatic diseases as assessed by the baseline examination or medical history (including life-time history of epileptic disorders)
- •5. Pathological results for vital signs, blood pressure and pulse
- •6. Reported pathological results for
- •6.1. Electrocardiogram (ECG) during the last 12 months
- •6.2. Differential blood count and hepatic metabolism during the last 6 months
- •7. Indication for hospitalization
- •8. Suicidality (assessed by Montgomery-Asberg Depression Rating Scale (MADRS) Item 10, Score >=3)
- •9. IQ <70 (clinically assessed)
- •10. Any psychotropic co-medication
- •11. Detention in an institution on official or judicial ruling
- •12. Unwillingness to transmit pseudonym data according to German regulations
- •13. Simultaneous participation in another clinical trial according to German Drug Law (AMG)
研究者
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