A Crossover Study on the Effect of Methylphenidate (MPH) on Cognitive Abilities of Adults With Bipolar Disorder (BD), During Remission or Depressed State, Compared With Healthy Adults and Adults With Attention Deficit Hyperactivity Disorder (ADHD).
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Cognitive function.
研究概览
简要总结
The purpose of the study is to explore the effect of MPH on working memory, attention and decision making in adults with BD in remission or in depressed state. The results will be compared to findings in healthy adults and adults with ADHD. The investigators hypothesize that MPH will incur improved performance in all measures.
详细描述
Following a detailed explanation about the trial and after obtaining informed consent from candidates, subjects will be asked to arrive at the cognitive laboratory at Shalvata MHC twice. Visits will include performance of computerized cognitive and decision making tasks, as well as two creativity tasks after the consumption of MPH or placebo.
研究设计
- 研究类型
- Interventional
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hebrew Speakers
- •Age 21-50
- •Diagnosis of BD I or II (296.7 and 296.89 classifications in the DSM-IV-TR), according to medical records. Diagnosis will be confirmed by a psychiatrist during screening process using the Structured Clinical Interview for DSM-IV-TR (SCID).
排除标准
- •Diagnosis of a clinical disorder other than BD or ADD/ADHD which may impair performance on tasks used in the study.
- •BD patients diagnosed with an acute manic episode at screening, as established by YMRS>
- •It will also be required that 3 months have elapsed since the latest manic state, according to the patients' history.
- •Participants for whom there exists a contra-indication for consuming Ritalin.
- •Pregnancy or current breastfeeding; Female participants will be asked to report whether they are pregnant or currently nursing and if so, they will be excluded from the study.
- •Drug use in the previous 6 weeks according to participants' self report
- •Electroconvulsive therapy (ECT) in the previous 6 months
研究组 & 干预措施
MPH or Placebo
MPH dosage will be determined according to participants' body weight: dosage: 10 mg in case weight<40 kg; 30 mg in case weight>90 kg; otherwise 20 mg. Both participants and investigators will be blinded to when participant receives MPH or Placebo.
干预措施: MPH (Drug)
MPH or Placebo
MPH dosage will be determined according to participants' body weight: dosage: 10 mg in case weight<40 kg; 30 mg in case weight>90 kg; otherwise 20 mg. Both participants and investigators will be blinded to when participant receives MPH or Placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Cognitive function.
时间窗: Within 4 hours of intervention.
Cognitive function will be measured by scores on several computerized neuro-psychological and decision making tasks: digit-span task, spatial working memory task, raven's progressive matrices, test of variable attention and the Iowa gambling task.
次要结局
- Creativity abilities.(Within 4 hours of intervention.)