A Pilot Trial of Homeopathic Treatment for Attention Deficit Hyperactivity Disorder

NCT01141634 | Completed Phase 2 DMC

• 2 other identifiers: UToronto -25628CAM09-213
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

Attention Deficit Hyperactivity Disorder; Attention Deficit Disorder; ADHD; ADD; Homeopathy

Outcome Measures

Primary Outcomes (1)

• Conners 3-Parent

  36 weeks

Secondary Outcomes (1)

• MYMOP2

  36 weeks

Interventions

Homeopathic Remedies OTHER

Homeopathic remedies prepared according to the standards as set out by Health Canada

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Toronto: lead
• SickKids Foundation: collaborator
• Centre for Addiction and Mental Health: collaborator
• University of Alberta: collaborator

Study Sites (1)

Riverdale Homeopathic Clinic

Toronto, Ontario, M4J 1N1, Canada

Location

Related Publications (1)

• Brule D, Sule L, Landau-Halpern B, Nastase V, Jain U, Vohra S, Boon H. An open-label pilot study of homeopathic treatment of attention deficit hyperactivity disorder in children and youth. Forsch Komplementmed. 2014;21(5):302-9. doi: 10.1159/000368137. Epub 2014 Sep 19.

  PMID: 25427521 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Materia Medica

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Study Officials

• Heather S Boon, PhD

  University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 8, 2010
• First Posted: June 10, 2010
• Study Start: June 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: March 7, 2014

Record last verified: 2014-03

Locations

CA (1)