Rhodiola Rosea 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

NCT02737020

150425

Details and patient eligibility

About

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.

Full 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.

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 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

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 200mg up to four times a day for 28 days

Treatment:

Drug: Rhodiola

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo