search
Back to results

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

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status
Unknown status
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Rhodiola
Placebo
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring ADHD, Adults, Treatment, Rhodiola

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital de Clínicas de Porto AlegreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Rhodiola

Placebo

Arm Description

Rhodiola rosea 800mg single dose

placebo 800mg single dose

Outcomes

Primary Outcome Measures

Change in Stop Signal Task
Change from baseline attention 4 hours after a single dose of Rhodiola 800mg or placebo

Secondary Outcome Measures

Change in Wechsler Adult Intelligence Scale (WAIS) - Digit Span subtest
Change from baseline attention 4 hours after a single dose of Rhodiola 800mg or placebo

Full Information

First Posted
March 7, 2016
Last Updated
May 27, 2019
Sponsor
Hospital de Clinicas de Porto Alegre
search

1. Study Identification

Unique Protocol Identification Number
NCT02737033
Brief Title
Effects of 800mg of Rhodiola Rosea in Attention in Adults With Attention-Deficit/Hyperactivity Disorder
Official Title
Effects of 800mg of Rhodiola Rosea in Attention in Adults With Attention-Deficit/Hyperactivity Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (Actual)
Primary Completion Date
March 2021 (Anticipated)
Study Completion Date
March 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
Keywords
ADHD, Adults, Treatment, Rhodiola

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rhodiola
Arm Type
Experimental
Arm Description
Rhodiola rosea 800mg single dose
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo 800mg single dose
Intervention Type
Drug
Intervention Name(s)
Rhodiola
Other Intervention Name(s)
Rhodiola rosea
Intervention Description
Rhodiola rosea 800mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo pill
Intervention Description
innocuous pill manufactured to mimic Rhodiola
Primary Outcome Measure Information:
Title
Change in Stop Signal Task
Description
Change from baseline attention 4 hours after a single dose of Rhodiola 800mg or placebo
Time Frame
Baseline and 4 hours
Secondary Outcome Measure Information:
Title
Change in Wechsler Adult Intelligence Scale (WAIS) - Digit Span subtest
Description
Change from baseline attention 4 hours after a single dose of Rhodiola 800mg or placebo
Time Frame
Baseline and 4 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eugenio Grevet, PhD
Phone
55 51 3359-8094
Email
ehgrevet@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eugenio Grevet, PhD
Organizational Affiliation
Hosptital de Clínicas de Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035-903
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eugenio H Grevet, PhD
Phone
555199877602
Email
ehgrevet@gmail.com
First Name & Middle Initial & Last Name & Degree
Marcelo M Victor, PhD
Phone
55 51 99639500
Email
mvictor@via-rs.net

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
21948938
Citation
Seixas M, Weiss M, Muller U. Systematic review of national and international guidelines on attention-deficit hyperactivity disorder. J Psychopharmacol. 2012 Jun;26(6):753-65. doi: 10.1177/0269881111412095. Epub 2011 Sep 24.
Results Reference
background
PubMed Identifier
19580697
Citation
Meszaros A, Czobor P, Balint S, Komlosi S, Simon V, Bitter I. Pharmacotherapy of adult attention deficit hyperactivity disorder (ADHD): a meta-analysis. Int J Neuropsychopharmacol. 2009 Sep;12(8):1137-47. doi: 10.1017/S1461145709990198. Epub 2009 Jul 7.
Results Reference
background
PubMed Identifier
20579741
Citation
Iovieno N, Dalton ED, Fava M, Mischoulon D. Second-tier natural antidepressants: review and critique. J Affect Disord. 2011 May;130(3):343-57. doi: 10.1016/j.jad.2010.06.010. Epub 2010 Jun 26.
Results Reference
background
PubMed Identifier
20378318
Citation
Panossian A, Wikman G, Sarris J. Rosenroot (Rhodiola rosea): traditional use, chemical composition, pharmacology and clinical efficacy. Phytomedicine. 2010 Jun;17(7):481-93. doi: 10.1016/j.phymed.2010.02.002. Epub 2010 Apr 7.
Results Reference
background
PubMed Identifier
21036578
Citation
Hung SK, Perry R, Ernst E. The effectiveness and efficacy of Rhodiola rosea L.: a systematic review of randomized clinical trials. Phytomedicine. 2011 Feb 15;18(4):235-44. doi: 10.1016/j.phymed.2010.08.014. Epub 2010 Oct 30.
Results Reference
background
PubMed Identifier
11081987
Citation
Darbinyan V, Kteyan A, Panossian A, Gabrielian E, Wikman G, Wagner H. Rhodiola rosea in stress induced fatigue--a double blind cross-over study of a standardized extract SHR-5 with a repeated low-dose regimen on the mental performance of healthy physicians during night duty. Phytomedicine. 2000 Oct;7(5):365-71. doi: 10.1016/S0944-7113(00)80055-0.
Results Reference
background
PubMed Identifier
15256690
Citation
De Bock K, Eijnde BO, Ramaekers M, Hespel P. Acute Rhodiola rosea intake can improve endurance exercise performance. Int J Sport Nutr Exerc Metab. 2004 Jun;14(3):298-307. doi: 10.1123/ijsnem.14.3.298.
Results Reference
background
PubMed Identifier
12725561
Citation
Shevtsov VA, Zholus BI, Shervarly VI, Vol'skij VB, Korovin YP, Khristich MP, Roslyakova NA, Wikman G. A randomized trial of two different doses of a SHR-5 Rhodiola rosea extract versus placebo and control of capacity for mental work. Phytomedicine. 2003 Mar;10(2-3):95-105. doi: 10.1078/094471103321659780.
Results Reference
background
PubMed Identifier
10839209
Citation
Spasov AA, Wikman GK, Mandrikov VB, Mironova IA, Neumoin VV. A double-blind, placebo-controlled pilot study of the stimulating and adaptogenic effect of Rhodiola rosea SHR-5 extract on the fatigue of students caused by stress during an examination period with a repeated low-dose regimen. Phytomedicine. 2000 Apr;7(2):85-9. doi: 10.1016/S0944-7113(00)80078-1.
Results Reference
background
PubMed Identifier
19016404
Citation
Olsson EM, von Scheele B, Panossian AG. A randomised, double-blind, placebo-controlled, parallel-group study of the standardised extract shr-5 of the roots of Rhodiola rosea in the treatment of subjects with stress-related fatigue. Planta Med. 2009 Feb;75(2):105-12. doi: 10.1055/s-0028-1088346. Epub 2008 Nov 18.
Results Reference
background
PubMed Identifier
6232345
Citation
Logan GD, Cowan WB, Davis KA. On the ability to inhibit simple and choice reaction time responses: a model and a method. J Exp Psychol Hum Percept Perform. 1984 Apr;10(2):276-91. doi: 10.1037//0096-1523.10.2.276.
Results Reference
background
PubMed Identifier
16275215
Citation
Mackin RS, Horner MD. Relationship of the Wender Utah Rating Scale to objective measures of attention. Compr Psychiatry. 2005 Nov-Dec;46(6):468-71. doi: 10.1016/j.comppsych.2005.03.004.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs