A Pilot Trial of Homeopathic Treatment for Attention Deficit Hyperactivity Disorder

University of Toronto

Status and phase

Completed

Phase 2

Conditions

Attention Deficit Hyperactivity Disorder

Treatments

Other: Homeopathic Remedies

Study type

Interventional

Funder types

Other

Identifiers

NCT01141634

CAM09-213 (Other Grant/Funding Number)

UToronto -25628

Details and patient eligibility

About

Attention Deficit Hyperactivity Disorder (ADHD) is a developmental disorder that presents during childhood, and is characterized by developmentally inappropriate levels of inattention and/or hyperactive-impulsive behavior. It is proposed that classical homeopathic treatment can reduce the symptoms of ADHD without serious side effects. This is an open label pilot feasibility study (36 participants). Participants, age 6-16, will consult with a homeopathic practitioner who will select treatments based on classical homeopathy principles. All participants will be assessed on a 4-weekly basis for a total of 36 weeks. The purpose of the study is to assess feasibility of recruitment and patient retention, to obtain pilot data on which to base a sample size calculation for future study, and to identify major safety concerns. The study will use single homeopathic medicines approved for over-the-counter use in Canada. The primary outcome measure will be the validated Conners 3rd Edition - Parent.

Enrollment

36 patients

Sex

All

Ages

6 to 16 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Males and females aged 6-16 diagnosed with ADHD of any subtype according to DSM-IV criteria.
Mentally competent participants able to adhere to the given protocol and treatments administered as interventions, and able to answer outcome measures.
Primary caregiver (parent or guardian) has given informed consent; child participant gives ongoing assent throughout the study.

Exclusion criteria

Changes to participants' medication for ADHD within 6 weeks of study onset.
Diagnosis of additional mental health disorder including but not limited to: Conduct Disorder, Autism Spectrum Disorder, Bipolar Disorder, and Major Depressive Disorder. The patient should not have current suicidal or homicidal ideation.
Participants should have no history of head injury of seizures, organ system damage and should have an estimated I.Q within the normal range.
Pregnancy and Lactation