NCT03190681已完成早期 1 期
Etude Comparative Monocentrique, randomisée, en Cross-over, en Double Aveugle, Contre Placebo, de l'Action du méthylphénidate Sur Les paramètres Cognitifs de la Motivation
Institut National de la Santé Et de la Recherche Médicale, France2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2017年7月11日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- coefficient of sensitivity to reward
研究概览
简要总结
The purpose of this study is to evaluate the impact of methylphenidate, a mixed dopaminergic and noradrenergic agent, onto the different components of motivation: decision-making, effort allocation and instrumental learning.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •weight>= 50kg and <=90kg
- •free and informed consent
- •social security affiliation
- •no chronic illness
- •no previous participation to a protocol wth similar tasks
- •no special legal status (guardianship,trusteeship)
- •no personnal or familial neurologic or psychiatric background
- •no contraceptive device for a reproductive woman
排除标准
- •inability to squeeze a handgrip
- •psychoactive substance consumption less than 3 weeks ago
- •pregnant or breastfeeding woman
- •hypersensitivity to methylphenidate
- •hyperthyroidism
- •cardiovascular or cerebrovascular disease
- •respiratory, hepatic or renal failure
- •pheochromocytoma
- •gluten intolerance or hypersensitivity
- •galactosemia, glucose malabsorption syndrome, lactase deficit
- •countraindicated meds (IMAO, IMAO-A, orhtosympathomimetics, alcaloids, linezolin, enzymatic inducers, psycho-active drugs)
研究组 & 干预措施
placebo then Ritalin (methylphenidate)
Experimental
干预措施: Placebo Oral Tablet (Drug)
Ritalin (methylphenidate) then placebo
Experimental
干预措施: Ritalin (methylphenidate)10Mg Tablet (Drug)
Ritalin (methylphenidate) then placebo
Experimental
干预措施: Placebo Oral Tablet (Drug)
placebo then Ritalin (methylphenidate)
Experimental
干预措施: Ritalin (methylphenidate)10Mg Tablet (Drug)
结局指标
主要结局
coefficient of sensitivity to reward
时间窗: two hours after administration
Parameter characterizing the influence of reward expectation/experience onto behavior for each individual. This parameter is estimated through the fit of computational models to behaviors recorded in a battery of motivational tasks (choice task, effort task, Learning task).
次要结局
- coefficient of sensitivity to effort(two hours after administration)
- coefficient of sensitivity to punishment(two hours after administration)
- coefficient of sensitivity to delay(two hours after administration)
研究者
研究点 (2)
Loading locations...
相似试验
招募中
2 期
The effects of methylphenidate and atomoxetine on emotional intelligence, executive function and self-efficacy of 12-18-year-old adolescents with ADHDIRCT20160523028008N31Hamedan University of Medical Sciences76
已完成
4 期
Methylphenidate and Driving Ability in Adult Patients With Attention-Deficit Hyperactivity DisorderADHDNCT00223561Utrecht Institute for Pharmaceutical Sciences18
招募中
1 期
Evaluation of the efficacy of Methylphenidate and modafinil in the treatment of excessive daily sleepiness in patients with drug-resistant epilepsy and comparison with the control groupEpilepsy.Epilepsy and recurrent seizuresIRCT20171030037093N22Esfahan University of Medical Sciences84
尚未招募
4 期
Methylphenidate in Adults with Severe Traumatic brain injury for the Enhancement of Recovery (MASTER)Traumatic brain injuryPhysical Medicine / Rehabilitation - Other physical medicine / rehabilitationInjuries and Accidents - Other injuries and accidentsACTRN12615001044516Royal Rehab20
招募中
3 期
????? ????? ???? ??????(???????) ?? ??? ??? ??????? ??????? ?? ???? ???? ????????IRCT20240415061495N1Oroumia University of Medical Sciences962