A Pilot Trial of Homeopathic Treatment for Attention Deficit Hyperactivity Disorder

Phase 2

Completed

• Conditions: Attention Deficit Hyperactivity Disorder

• Registration Number: NCT01141634
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-06-08
• Study First Submitted QC: 2010-06-08
• Study First Posted: 2010-06-10
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-06
• Last Update Posted: 2014-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Conners 3-Parent	36 weeks

Secondary Outcome Measures

Name	Time	Method
MYMOP2	36 weeks

Trial Locations

Locations (1)

Riverdale Homeopathic Clinic; 🇨🇦 Toronto, Ontario, Canada