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

May 27, 2019 updated by: Hospital de Clinicas de Porto Alegre
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
        • Recruiting
        • Hospital de Clinicas de Porto Alegre
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rhodiola
Rhodiola rosea 800mg single dose
Drug: Rhodiola
Rhodiola rosea 800mg
Other Names:
  • Rhodiola rosea
Placebo Comparator: Placebo
placebo 800mg single dose
Drug: Placebo
innocuous pill manufactured to mimic Rhodiola
Other Names:
  • Placebo pill

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Clinicas de Porto Alegre

Investigators

  • Principal Investigator: Eugenio Grevet, PhD, Hosptital de Clínicas de Porto Alegre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2016

Primary Completion (Anticipated)

March 1, 2021

Study Completion (Anticipated)

March 1, 2021

Study Registration Dates

First Submitted

March 7, 2016

First Submitted That Met QC Criteria

April 7, 2016

First Posted (Estimate)

April 13, 2016

Study Record Updates

Last Update Posted (Actual)

May 29, 2019

Last Update Submitted That Met QC Criteria

May 27, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 150426

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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