Rhodiola Rosea in Adults With Attention Deficit/Hyperactivity Disorder

Sponsor

Hospital de Clinicas de Porto Alegre (Other)

Overall Status

Unknown status

CT.gov ID

NCT02737020

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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.

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

Study Type:

Interventional

Anticipated 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 :

Apr 1, 2016

Anticipated Primary Completion Date :

Mar 1, 2021

Anticipated Study Completion Date :

Mar 1, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change in Swanson, Nolan and Pelham Rating Scale - Version IV (SNAP-IV) adapted to adults [Change from baseline SNAP-IV at 4 weeks]

Secondary Outcome Measures

Change in Adult Self-Report Scale (ASRS) [Change from baseline ASRS at 4 weeks]

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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