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A Pilot Trial of Homeopathic Treatment for Attention Deficit Hyperactivity Disorder

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Homeopathic Remedies
Sponsored by
University of Toronto
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring Attention Deficit Hyperactivity Disorder, Attention Deficit Disorder, ADHD, ADD, Homeopathy

Eligibility Criteria

6 Years - 16 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • Riverdale Homeopathic Clinic

Outcomes

Primary Outcome Measures

Conners 3-Parent

Secondary Outcome Measures

MYMOP2

Full Information

First Posted
June 8, 2010
Last Updated
March 6, 2014
Sponsor
University of Toronto
Collaborators
SickKids Foundation, Centre for Addiction and Mental Health, University of Alberta
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1. Study Identification

Unique Protocol Identification Number
NCT01141634
Brief Title
A Pilot Trial of Homeopathic Treatment for Attention Deficit Hyperactivity Disorder
Official Title
A Pilot Trial of Homeopathic Treatment for Attention Deficit Hyperactivity Disorder in Children and Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Toronto
Collaborators
SickKids Foundation, Centre for Addiction and Mental Health, University of Alberta

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
Keywords
Attention Deficit Hyperactivity Disorder, Attention Deficit Disorder, ADHD, ADD, Homeopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
Homeopathic Remedies
Intervention Description
Homeopathic remedies prepared according to the standards as set out by Health Canada
Primary Outcome Measure Information:
Title
Conners 3-Parent
Time Frame
36 weeks
Secondary Outcome Measure Information:
Title
MYMOP2
Time Frame
36 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heather S Boon, PhD
Organizational Affiliation
University of Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riverdale Homeopathic Clinic
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4J 1N1
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
25427521
Citation
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.
Results Reference
derived

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A Pilot Trial of Homeopathic Treatment for Attention Deficit Hyperactivity Disorder

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