Rhodiola Rosea in Adults With Attention Deficit/Hyperactivity Disorder

Phase 4

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

• Registration Number: NCT02737020
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

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.

Study Timeline

• Study First Submitted: 2016-03-09
• 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 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rhodiola	Rhodiola	Rhodiola rosea 200mg up to four times a day for 28 days
Placebo	Placebo	Placebo pill manufactured to mimic Rhodiola rosea 200mg, up to four times a day for 28 days

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Change in Adult Self-Report Scale (ASRS)	Change from baseline ASRS at 4 weeks

Trial Locations

Locations (1)

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