Effects of 800mg of Rhodiola Rosea in Attention in Adults With Attention-Deficit/Hyperactivity Disorder

Study Overview
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Brief Summary
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This study evaluates the use of Rhodiola rosea in the attention of adults with Attention Deficit/Hyperactivity Disorder (ADHD). Half of participants will receive Rhodiola rosea 800mg, while the other half will receive 800mg of placebo.

Detailed Description
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The evaluation of new therapies in adults with Attention Deficit/Hyperactivity Disorder (ADHD) may be clinically useful. 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 has never been studied in adults with ADHD.

Official Title
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Effects of 800mg of Rhodiola Rosea in Attention in Adults With Attention-Deficit/Hyperactivity Disorder

Conditions
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Attention Deficit Hyperactivity Disorder

Intervention / Treatment
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* Drug: Rhodiola
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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 to Rhodiola rosea any unstable chronic illness without proper treatment (hypertension, heart, kidney or liver disease, etc) 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rhodiola<br>Rhodiola rosea 800mg single dose | Drug: Rhodiola<br>* Rhodiola rosea 800mg<br>* Other names: Rhodiola rosea;|
| Placebo Comparator: Placebo<br>placebo 800mg single dose | Drug: Placebo<br>* innocuous pill manufactured to mimic Rhodiola<br>* Other names: Placebo pill;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Stop Signal Task | Change from baseline attention 4 hours after a single dose of Rhodiola 800mg or placebo | Baseline and 4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Wechsler Adult Intelligence Scale (WAIS) - Digit Span subtest | Change from baseline attention 4 hours after a single dose of Rhodiola 800mg or placebo | Baseline and 4 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADHD, Adults, Treatment, Rhodiola