Clinical trial NCT02737020: Rhodiola Rosea in Adults With Attention Deficit/Hyperactivity Disorder
Official title: Rhodiola Rosea 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 rosea
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 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.

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

Primary outcomes:
measure: Change in Swanson, Nolan and Pelham Rating Scale - Version IV (SNAP-IV) adapted to adults
timeFrame: Change from baseline SNAP-IV at 4 weeks
Secondary outcomes:
measure: Change in Adult Self-Report Scale (ASRS)
timeFrame: Change from baseline ASRS at 4 weeks
Other outcomes:
measure: Change in Wechsler Scale digit subtest (WAIS-III)
timeFrame: Change from baseline WAIS-III at 4 weeks
measure: Change in Stop Signal Task
timeFrame: Change from baseline Stop Signal Task at 4 weeks
measure: Change in Barkley Side Effect Rating Scale (SERS)
timeFrame: Change from baseline SERS at 4 weeks
measure: Change in Insomnia Severity Index (ISI)
timeFrame: Change from baseline ISI at 4 weeks
measure: Change in Beck-II Depression Scale
timeFrame: Change from baseline Beck-II Depression Scale at 4 weeks
measure: Change in Beck Anxiety Scale
timeFrame: Change from baseline Beck Anxiety Scale at 4 weeks
measure: Change in Adult ADHD Quality of Life Questionnaire (AAQoL)
timeFrame: Change from baseline AAQoL at 4 weeks
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande Do Sul
Study officials:
affiliation: Hospital de Clínicas de Porto Alegre
name: Eugenio Grevet, PhD
role: PRINCIPAL_INVESTIGATOR
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