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

Hospital de Clinicas de Porto Alegre

Status and phase: Unknown; Phase 4

Conditions: Attention Deficit Hyperactivity Disorder

Treatments: Drug: Rhodiola; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02737033

150426

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Rhodiola

Experimental group

Description:

Rhodiola rosea 800mg single dose

Treatment:

Drug: Rhodiola

Placebo

Placebo Comparator group

Description:

placebo 800mg single dose

Treatment:

Drug: Placebo