Motivated Behavior in Adults With and Without ADHD
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Number of High-effort Selections in the Effort-based Decision Making Task
研究概览
简要总结
To investigate the effects of methylphenidate on motivated behavior in adults with and without ADHD
详细描述
This study has a mixed between- and within-subject design. Participants are young adults (aged 18-45) with ADHD and non-ADHD matched controls. They will be recruited from locations around the community, consented, screened for eligibility, then scheduled for 2 study days. Study days will be at least 48 hours apart. Thus, there will be a total of 3 lab visits across a 3 week period. Participants will be administered study drug on one study day and placebo on the other study day. They will complete a battery of cognitive/behavioral tasks and answer questionnaires on both study days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •generally healthy
- •between the ages of 18-45
- •non-ADHD subjects do not meet criteria for ADHD diagnosis or any subtype as determined by the Conners Diagnostic Interview or any T-Score > 55 on Inattentive Symptoms, Hyperactive-Impulsive Symptoms, Total Symptoms or ADHD Index subscales of the CAARS.
- •ADHD subjects meet criteria for a primary diagnosis of ADHD, any subtype, based on DSM-5
排除标准
- •inability to attend all required experimental sessions
- •significant health problems (e.g., current and uncontrolled liver, lung, or heart problems, current or past seizure disorder, serious head trauma)
- •primary diagnosis of Axis I psychiatric disorders other than ADHD (e.g., depression, anxiety disorder, schizophrenia)
- •meet DSM-5 criteria for substance use disorder other than nicotine in the past 12 months
- •use of psychoactive medications in the past 6 months as indicated by self-report
- •positive urine drug screen for drugs or positive breath alcohol concentration
- •contraindications for MPH
- •among women, nursing or a positive pregnancy test
- •IQ < 80 on Kaufman Brief Intelligence Test, 2nd edition
- •allergy to lactose
- •hypertension (If subject is ≤ 40 years of age and has blood pressure over 135/85 or heart rate over 90 beats per minute. If subject is > 40 years of age and has blood pressure over 130/80 or heart rate over 88 beats per minute)
- •body mass ratio > 30
研究组 & 干预措施
ADHD group
Adults with ADHD
干预措施: ADHD methylphenidate first, placebo second (Drug)
ADHD group
Adults with ADHD
干预措施: ADHD placebo first, methylphenidate second (Drug)
non-ADHD group
Adults without ADHD
干预措施: Non-ADHD methylphenidate first, placebo second (Drug)
non-ADHD group
Adults without ADHD
干预措施: Non-ADHD placebo first, methylphenidate second (Drug)
结局指标
主要结局
Number of High-effort Selections in the Effort-based Decision Making Task
时间窗: 1 hour post drug (or placebo) administration for each study session
Number of high-effort selections in the effort-based decision making task from the placebo to the methylphenidate condition. This is a decision-making task where participants make high- or low-effort choices to earn a small financial reward. High-effort selections require 100 button presses with non-dominant hand pinky finger and low-effort selections require 30 button presses with dominant hand index finger (within 15 seconds). The number of high effort selections are summed across 50 trials of the task. This task measures the willingness to perform effort in relation to changing reward magnitude and probability. This is a basic science experiment, the clinical and/or physiological relevance of these results are not established.
次要结局
未报告次要终点