Rhodiola Rosea in Adults With Attention Deficit/Hyperactivity Disorder
关键词
抽象
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.
日期
| 最后验证: | 04/30/2019 |
| 首次提交: | 03/08/2016 |
| 提交的预估入学人数: | 04/06/2016 |
| 首次发布: | 04/12/2016 |
| 上次提交的更新: | 05/26/2019 |
| 最近更新发布: | 05/28/2019 |
| 实际学习开始日期: | 03/31/2016 |
| 预计主要完成日期: | 02/28/2021 |
| 预计完成日期: | 02/28/2021 |
状况或疾病
干预/治疗
Drug: Rhodiola
Drug: Placebo
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: Rhodiola Rhodiola rosea 200mg up to four times a day for 28 days | Drug: Rhodiola Rhodiola rosea 200mg pill up to four times a day |
| Placebo Comparator: Placebo Placebo pill manufactured to mimic Rhodiola rosea 200mg, up to four times a day for 28 days | Drug: Placebo up to four times a day |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
结果
主要结果指标
1. Change in Swanson, Nolan and Pelham Rating Scale - Version IV (SNAP-IV) adapted to adults [Change from baseline SNAP-IV at 4 weeks]
次要成果指标
1. Change in Adult Self-Report Scale (ASRS) [Change from baseline ASRS at 4 weeks]
其他成果措施
1. Change in Wechsler Scale digit subtest (WAIS-III) [Change from baseline WAIS-III at 4 weeks]
2. Change in Stop Signal Task [Change from baseline Stop Signal Task at 4 weeks]
3. Change in Barkley Side Effect Rating Scale (SERS) [Change from baseline SERS at 4 weeks]
4. Change in Insomnia Severity Index (ISI) [Change from baseline ISI at 4 weeks]
5. Change in Beck-II Depression Scale [Change from baseline Beck-II Depression Scale at 4 weeks]
6. Change in Beck Anxiety Scale [Change from baseline Beck Anxiety Scale at 4 weeks]
7. Change in Adult ADHD Quality of Life Questionnaire (AAQoL) [Change from baseline AAQoL at 4 weeks]
