A Pilot Trial of Homeopathic Treatment for Attention Deficit Hyperactivity Disorder
March 6, 2014 updated by: Heather Boon, University of Toronto
A Pilot Trial of Homeopathic Treatment for Attention Deficit Hyperactivity Disorder in Children and Adolescents
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M4J 1N1
- Riverdale Homeopathic Clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 16 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Conners 3-Parent
Time Frame: 36 weeks
|
36 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
MYMOP2
Time Frame: 36 weeks
|
36 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Heather S Boon, PhD, University of Toronto
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2010
Primary Completion (ACTUAL)
December 1, 2012
Study Completion (ACTUAL)
December 1, 2012
Study Registration Dates
First Submitted
June 8, 2010
First Submitted That Met QC Criteria
June 8, 2010
First Posted (ESTIMATE)
June 10, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
March 7, 2014
Last Update Submitted That Met QC Criteria
March 6, 2014
Last Verified
March 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UToronto -25628
- CAM09-213 (OTHER_GRANT: SickKids Foundation)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.