Attention Deficit/Hyperactivity Disorder
Conditions
Keywords
ADHD, Adults, Treatment, Rhodiola rosea
Brief summary
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.
Detailed 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.
Interventions
DRUGRhodiola
Rhodiola rosea 200mg pill up to four times a day
DRUGPlacebo
up to four times a day
Sponsors
Hospital de Clinicas de Porto Alegre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Swanson, Nolan and Pelham Rating Scale - Version IV (SNAP-IV) adapted to adults | Change from baseline SNAP-IV at 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change in Adult Self-Report Scale (ASRS) | Change from baseline ASRS at 4 weeks |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Barkley Side Effect Rating Scale (SERS) | Change from baseline SERS at 4 weeks | Including Rhodiola rosea side effects |
| Change in Insomnia Severity Index (ISI) | Change from baseline ISI at 4 weeks | — |
| Change in Wechsler Scale digit subtest (WAIS-III) | Change from baseline WAIS-III at 4 weeks | — |
| Change in Beck Anxiety Scale | Change from baseline Beck Anxiety Scale at 4 weeks | — |
| Change in Adult ADHD Quality of Life Questionnaire (AAQoL) | Change from baseline AAQoL at 4 weeks | — |
| Change in Beck-II Depression Scale | Change from baseline Beck-II Depression Scale at 4 weeks | — |
| Change in Stop Signal Task | Change from baseline Stop Signal Task at 4 weeks | — |
Countries
Brazil
Contacts
Primary ContactEugenio Grevet, PhD
Outcome results
None listed