CTRI/2010/091/001453尚未招募3 期
Evaluation of Efficacy And Safety of IP-020 in the treatment of Attention deficit hyperactivity disorder (ADHD): A randomized, double-blind, placebo-controlled, multi-center study.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 200
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
入选标准
- •1.Male or Female patients aged 6 to 18.
- •2.Patients diagnosed with ADHD by DSM-IV for ADHD criteria will be enrolled for the study.
- •3.Patients whose parents and/or guardians provide written informed consent. (Parents and/or guardians signature is mandatory).
排除标准
- •1.Patients who has concurrent of history of a significant medical or psychiatric illness (schizophrenia, bipolar disorder or autism) that could have interfered with study participation or assessments.
- •2.Patients who has marked anxiety, tension and agitation.
- •3.Patients with Cardiovascular disease or problem.
- •4.Patients with Glaucoma.
- •5.Patients with a known or suspected history of drug or alcohol abuse or dependence within the previous 6 months.
- •6.Patients have a history of poor response or intolerance of CNS stimulant viz. amphetamines salts or dextro-amphetamine salts.
- •7.Patients who are taking Clonidine or other centrally-acting alpha-2-agonists.
- •8.Patinets who are hypersensitive to Mehylphenidate.
- •9.Patients with clinically significant abnormal Vital Signs, judged by investigator.
研究者
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