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A Pilot Trial of Homeopathic Treatment for Attention Deficit Hyperactivity Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01141634
Recruitment Status : Completed
First Posted : June 10, 2010
Last Update Posted : March 7, 2014
SickKids Foundation
Centre for Addiction and Mental Health
University of Alberta
Information provided by (Responsible Party):
Heather Boon, University of Toronto

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.

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Other: Homeopathic Remedies Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Trial of Homeopathic Treatment for Attention Deficit Hyperactivity Disorder in Children and Adolescents
Study Start Date : June 2010
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Intervention Details:
  • Other: Homeopathic Remedies
    Homeopathic remedies prepared according to the standards as set out by Health Canada

Primary Outcome Measures :
  1. Conners 3-Parent [ Time Frame: 36 weeks ]

Secondary Outcome Measures :
  1. MYMOP2 [ Time Frame: 36 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   6 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01141634

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Canada, Ontario
Riverdale Homeopathic Clinic
Toronto, Ontario, Canada, M4J 1N1
Sponsors and Collaborators
University of Toronto
SickKids Foundation
Centre for Addiction and Mental Health
University of Alberta
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Principal Investigator: Heather S Boon, PhD University of Toronto
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Heather Boon, Principal Investigator, University of Toronto Identifier: NCT01141634    
Other Study ID Numbers: UToronto -25628
CAM09-213 ( Other Grant/Funding Number: SickKids Foundation )
First Posted: June 10, 2010    Key Record Dates
Last Update Posted: March 7, 2014
Last Verified: March 2014
Keywords provided by Heather Boon, University of Toronto:
Attention Deficit Hyperactivity Disorder
Attention Deficit Disorder
Additional relevant MeSH terms:
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Attention Deficit Disorder with Hyperactivity
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases