Rhodiola Rosea 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 treatment of Attention Deficit/Hyperactivity Disorder (ADHD) in adults. Half of participants will receive Rhodiola rosea, while the other half will receive placebo.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 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 Contact

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 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 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 200mg up to four times a day for 28 days
Drug: Rhodiola
Rhodiola rosea 200mg pill up to four times a day
Other Names:
  • Rhodiola rosea
Placebo Comparator: Placebo
Placebo pill manufactured to mimic Rhodiola rosea 200mg, up to four times a day for 28 days
Drug: Placebo
up to four times a day
Other Names:
  • pill manufactured to mimic Rhodiola rosea 200mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Swanson, Nolan and Pelham Rating Scale - Version IV (SNAP-IV) adapted to adults
Time Frame: Change from baseline SNAP-IV at 4 weeks
Change from baseline SNAP-IV at 4 weeks

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Wechsler Scale digit subtest (WAIS-III)
Time Frame: Change from baseline WAIS-III at 4 weeks
Change from baseline WAIS-III at 4 weeks
Change in Stop Signal Task
Time Frame: Change from baseline Stop Signal Task at 4 weeks
Change from baseline Stop Signal Task at 4 weeks
Change in Barkley Side Effect Rating Scale (SERS)
Time Frame: Change from baseline SERS at 4 weeks
Including Rhodiola rosea side effects
Change from baseline SERS at 4 weeks
Change in Insomnia Severity Index (ISI)
Time Frame: Change from baseline ISI at 4 weeks
Change from baseline ISI at 4 weeks
Change in Beck-II Depression Scale
Time Frame: Change from baseline Beck-II Depression Scale at 4 weeks
Change from baseline Beck-II Depression Scale at 4 weeks
Change in Beck Anxiety Scale
Time Frame: Change from baseline Beck Anxiety Scale at 4 weeks
Change from baseline Beck Anxiety Scale at 4 weeks
Change in Adult ADHD Quality of Life Questionnaire (AAQoL)
Time Frame: Change from baseline AAQoL at 4 weeks
Change from baseline AAQoL at 4 weeks

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, Hospital de Clinicas 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 9, 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

  • 150425

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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