Rhodiola Rosea in Adults With Attention Deficit/Hyperactivity Disorder

Study Overview
=================
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.

Official Title
-----------------
Rhodiola Rosea in Adults With Attention Deficit/Hyperactivity Disorder

Conditions
-----------------
Attention Deficit/Hyperactivity Disorder

Intervention / Treatment
-----------------
* Drug: Rhodiola
* Drug: Placebo


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

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 200mg up to four times a day for 28 days | Drug: Rhodiola<br>* Rhodiola rosea 200mg pill up to four times a day<br>* Other names: Rhodiola rosea;|
| Placebo Comparator: Placebo<br>Placebo pill manufactured to mimic Rhodiola rosea 200mg, up to four times a day for 28 days | Drug: Placebo<br>* up to four times a day<br>* Other names: pill manufactured to mimic Rhodiola rosea 200mg;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Adult Self-Report Scale (ASRS) |  | Change from baseline ASRS at 4 weeks | 

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