Rhodiola Rosea in Adults With Attention Deficit/Hyperactivity Disorder
试验速览
- 阶段
- 4 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Swanson, Nolan and Pelham Rating Scale - Version IV (SNAP-IV) adapted to adults
研究概览
简要总结
This study evaluates the use of Rhodiola rosea in the treatment of Attention Deficit/Hyperactivity Disorder (ADHD) in adults. Half of participants will receive Rhodiola rosea, while the other half will receive placebo.
详细描述
Rhodiola rosea is an herbal medicine used for centuries in various medical conditions. Many randomized controlled trials have evaluated its usefulness in stress and fatigue. There were benefits in attention in some of these studies. Mild side effects and beneficial antioxidant properties make reasonable an assessment of its potential benefits in adults with ADHD. To our knowledge, Rhodiola rosea was never studied in ADHD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fulfillment of Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, (DSM-5) diagnostic criteria for ADHD in Adults
- •Intelligence Quotient (IQ) above 70
- •Eligibility to Rhodiola rosea
排除标准
- •clinical contraindication fro Rhodiola rosea -
- •any unstable chronic illness without proper treatment (hypertension, heart, kidney or liver disease)
- •any significant neurological disease (delirium, dementia, epilepsy, AIDS, head trauma, multiple sclerosis, stroke, etc)
- •unstable psychiatric comorbidities requiring immediate treatment (risk of suicide, current Substance Use Disorder, etc.)
- •pregnant, nursing or absence of reliable contraception
- •current use of nicotine (<30 days)
- •use of anticoagulants
- •current use of any psychoactive drug (<30 days)
- •prior use of stimulants
- •current or lifetime psychosis- current or lifetime bipolar disorder
研究组 & 干预措施
Rhodiola
Rhodiola rosea 200mg up to four times a day for 28 days
干预措施: Rhodiola (Drug)
Placebo
Placebo pill manufactured to mimic Rhodiola rosea 200mg, up to four times a day for 28 days
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Swanson, Nolan and Pelham Rating Scale - Version IV (SNAP-IV) adapted to adults
时间窗: Change from baseline SNAP-IV at 4 weeks
次要结局
- Change in Adult Self-Report Scale (ASRS)(Change from baseline ASRS at 4 weeks)