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A Pilot Trial of Homeopathic Treatment for Attention Deficit Hyperactivity Disorder

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by University of Toronto.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
SickKids Foundation
Centre for Addiction and Mental Health
University of Alberta
Information provided by (Responsible Party):
University of Toronto
ClinicalTrials.gov Identifier:
NCT01141634
First received: June 8, 2010
Last updated: January 26, 2012
Last verified: June 2010
History of Changes
  Purpose

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 Intervention Phase
Attention Deficit Hyperactivity Disorder
 Other: Homeopathic Remedies
 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Trial of Homeopathic Treatment for Attention Deficit Hyperactivity Disorder in Children and Adolescents

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Toronto:

Primary Outcome Measures:
  • Conners 3-Parent [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • MYMOP2 [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: June 2010
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Homeopathic Remedies
    Homeopathic remedies prepared according to the standards as set out by Health Canada
  Eligibility

Ages Eligible for Study:   6 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01141634

Locations
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
Investigators
Principal Investigator: Heather S Boon, PhD University of Toronto
  More Information

No publications provided

Responsible Party: University of Toronto
ClinicalTrials.gov Identifier: NCT01141634     History of Changes
Other Study ID Numbers: UToronto -25628, CAM09-213
Study First Received: June 8, 2010
Last Updated: January 26, 2012
Health Authority: Canada: Health Canada

Keywords provided by University of Toronto:
Attention Deficit Hyperactivity Disorder
Attention Deficit Disorder
ADHD
ADD
Homeopathy

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
 Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013