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OpenTrials
Completed

NCT Number: NCT01141634

A Pilot Trial of Homeopathic Treatment for Attention Deficit Hyperactivity Disorder

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.

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Key information

Conditions

Attention Deficit Hyperactivity Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

6 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Riverdale Homeopathic Clinic

Toronto, Ontario, M4J 1N1, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Homeopathic Remedies

Other

Homeopathic remedies prepared according to the standards as set out by Health Canada

Primary outcomes

  1. Conners 3-Parent

    Time frame: 36 weeks

Secondary outcomes

  1. MYMOP2

    Time frame: 36 weeks

Sponsors and collaborators

Lead sponsor

University of Toronto

Other

Collaborators

  • Centre for Addiction and Mental Health
  • SickKids Foundation
  • University of Alberta

Registry information

Official study title

A Pilot Trial of Homeopathic Treatment for Attention Deficit Hyperactivity Disorder in Children and Adolescents

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jun 10, 2010
Registry last updated
Mar 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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