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Rhodiola Rosea 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 rosea

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 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

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 200mg up to four times a day for 28 days

Placebo pill manufactured to mimic Rhodiola rosea 200mg, up to four times a day for 28 days

Outcomes

Primary Outcome Measures

Change in Swanson, Nolan and Pelham Rating Scale - Version IV (SNAP-IV) adapted to adults

Secondary Outcome Measures

Change in Adult Self-Report Scale (ASRS)

Full Information

First Posted
March 9, 2016
Last Updated
May 27, 2019
Sponsor
Hospital de Clinicas de Porto Alegre
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1. Study Identification

Unique Protocol Identification Number
NCT02737020
Brief Title
Rhodiola Rosea in Adults With Attention Deficit/Hyperactivity Disorder
Official Title
Rhodiola Rosea 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 treatment of Attention Deficit/Hyperactivity Disorder (ADHD) in adults. Half of participants will receive Rhodiola rosea, while the other half will receive placebo.
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.

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 rosea

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 200mg up to four times a day for 28 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo pill manufactured to mimic Rhodiola rosea 200mg, up to four times a day for 28 days
Intervention Type
Drug
Intervention Name(s)
Rhodiola
Other Intervention Name(s)
Rhodiola rosea
Intervention Description
Rhodiola rosea 200mg pill up to four times a day
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
pill manufactured to mimic Rhodiola rosea 200mg
Intervention Description
up to four times a day
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Change in Adult Self-Report Scale (ASRS)
Time Frame
Change from baseline ASRS at 4 weeks
Other Pre-specified Outcome Measures:
Title
Change in Wechsler Scale digit subtest (WAIS-III)
Time Frame
Change from baseline WAIS-III at 4 weeks
Title
Change in Stop Signal Task
Time Frame
Change from baseline Stop Signal Task at 4 weeks
Title
Change in Barkley Side Effect Rating Scale (SERS)
Description
Including Rhodiola rosea side effects
Time Frame
Change from baseline SERS at 4 weeks
Title
Change in Insomnia Severity Index (ISI)
Time Frame
Change from baseline ISI at 4 weeks
Title
Change in Beck-II Depression Scale
Time Frame
Change from baseline Beck-II Depression Scale at 4 weeks
Title
Change in Beck Anxiety Scale
Time Frame
Change from baseline Beck Anxiety Scale at 4 weeks
Title
Change in Adult ADHD Quality of Life Questionnaire (AAQoL)
Time Frame
Change from baseline AAQoL at 4 weeks

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 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
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
Hospital 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
55 51 99877602
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
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Rhodiola Rosea in Adults With Attention Deficit/Hyperactivity Disorder

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