Clinical trial NCT02737033: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: ADHD
Adults
Treatment
Rhodiola
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2016-04-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Stop Signal Task
timeFrame: Baseline and 4 hours
Secondary outcomes:
measure: Change in Wechsler Adult Intelligence Scale (WAIS) - Digit Span subtest
timeFrame: Baseline and 4 hours
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande Do Sul
Study officials:
affiliation: Hosptital de Clínicas de Porto Alegre
name: Eugenio Grevet, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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