Rhodiola Rosea in Adults With Attention Deficit/Hyperactivity Disorder
Keywords
Abstract
Description
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.
Dates
| Last Verified: | 04/30/2019 |
| First Submitted: | 03/08/2016 |
| Estimated Enrollment Submitted: | 04/06/2016 |
| First Posted: | 04/12/2016 |
| Last Update Submitted: | 05/26/2019 |
| Last Update Posted: | 05/28/2019 |
| Actual Study Start Date: | 03/31/2016 |
| Estimated Primary Completion Date: | 02/28/2021 |
| Estimated Study Completion Date: | 02/28/2021 |
Condition or disease
Intervention/treatment
Drug: Rhodiola
Drug: Placebo
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| 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 |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | 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 |
Outcome
Primary Outcome Measures
1. Change in Swanson, Nolan and Pelham Rating Scale - Version IV (SNAP-IV) adapted to adults [Change from baseline SNAP-IV at 4 weeks]
Secondary Outcome Measures
1. Change in Adult Self-Report Scale (ASRS) [Change from baseline ASRS at 4 weeks]
Other Outcome Measures
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]
