The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02737033
Recruitment Status : Unknown
Verified May 2019 by Hospital de Clinicas de Porto Alegre.
Recruitment status was:  Recruiting
First Posted : April 13, 2016
Last Update Posted : May 29, 2019
Sponsor:
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Drug: Rhodiola Drug: Placebo Phase 4

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of 800mg of Rhodiola Rosea in Attention in Adults With Attention-Deficit/Hyperactivity Disorder
Actual Study Start Date : April 2016
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Rhodiola
Rhodiola rosea 800mg single dose
 Drug: Rhodiola
Rhodiola rosea 800mg
Other Name: Rhodiola rosea
Placebo Comparator: Placebo
placebo 800mg single dose
 Drug: Placebo
innocuous pill manufactured to mimic Rhodiola
Other Name: Placebo pill


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02737033


Contacts
Layout table for location contacts
Contact: Eugenio Grevet, PhD 55 51 3359-8094 ehgrevet@gmail.com

Locations
Layout table for location information
Brazil
Hospital de Clínicas de Porto Alegre Recruiting
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
Contact: Eugenio H Grevet, PhD    555199877602    ehgrevet@gmail.com   
Contact: Marcelo M Victor, PhD    55 51 99639500    mvictor@via-rs.net   
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
Layout table for investigator information
Principal Investigator: Eugenio Grevet, PhD Hosptital de Clínicas de Porto Alegre
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT02737033    
Other Study ID Numbers: 150426
First Posted: April 13, 2016    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Hospital de Clinicas de Porto Alegre:
ADHD
Adults
Treatment
Rhodiola
Additional relevant MeSH terms:
Layout table for MeSH terms
Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
 Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases