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

Phase 4

• Conditions: Attention Deficit Hyperactivity Disorder
• Interventions: Drug: Rhodiola; Drug: Placebo

• Registration Number: NCT02737033
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2016-03-07
• Study Start: 2016-04
• Study First Submitted QC: 2016-04-07
• Study First Posted: 2016-04-13
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-27
• Last Update Posted: 2019-05-29
• Primary Completion: 2021-03
• Study Completion: 2021-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rhodiola	Rhodiola	Rhodiola rosea 800mg single dose
Placebo	Placebo	placebo 800mg single dose

Primary Outcome Measures

Name	Time	Method
Change in Stop Signal Task	Baseline and 4 hours	Change from baseline attention 4 hours after a single dose of Rhodiola 800mg or placebo

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital de Clínicas de Porto Alegre; 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil