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Rhodiola Rosea in Adults With Attention Deficit/Hyperactivity Disorder

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ClinicalTrials.gov Identifier: NCT02737020
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
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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.

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

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 Design
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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: Rhodiola Rosea 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
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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 Name: 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 Name: pill manufactured to mimic Rhodiola rosea 200mg


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Change in Adult Self-Report Scale (ASRS) [ Time Frame: Change from baseline ASRS at 4 weeks ]

Other Outcome Measures:
  1. Change in Wechsler Scale digit subtest (WAIS-III) [ Time Frame: Change from baseline WAIS-III at 4 weeks ]
  2. Change in Stop Signal Task [ Time Frame: Change from baseline Stop Signal Task at 4 weeks ]
  3. Change in Barkley Side Effect Rating Scale (SERS) [ Time Frame: Change from baseline SERS at 4 weeks ]
    Including Rhodiola rosea side effects

  4. Change in Insomnia Severity Index (ISI) [ Time Frame: Change from baseline ISI at 4 weeks ]
  5. Change in Beck-II Depression Scale [ Time Frame: Change from baseline Beck-II Depression Scale at 4 weeks ]
  6. Change in Beck Anxiety Scale [ Time Frame: Change from baseline Beck Anxiety Scale at 4 weeks ]
  7. Change in Adult ADHD Quality of Life Questionnaire (AAQoL) [ Time Frame: Change from baseline AAQoL at 4 weeks ]

Eligibility Criteria
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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 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
Contacts and Locations
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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): NCT02737020


Contacts
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Contact: Eugenio Grevet, PhD 55 51 3359-8094 ehgrevet@gmail.com

Locations
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Brazil
Hospital de Clínicas de Porto Alegre Recruiting
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
Contact: Eugenio H Grevet, PhD    55 51 99877602    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
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Principal Investigator: Eugenio Grevet, PhD Hospital de Clínicas de Porto Alegre
More Information
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Publications:

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Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT02737020    
Other Study ID Numbers: 150425
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 rosea
Additional relevant MeSH terms:
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Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
 Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases