A Pilot Trial of Homeopathic Treatment for Attention Deficit Hyperactivity Disorder

NCT ID: NCT01141634

Last Updated: 2014-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2012-12-31

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.

Conditions

Attention Deficit Hyperactivity Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Homeopathic Remedies

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SickKids Foundation

OTHER

Sponsor Role: collaborator

Centre for Addiction and Mental Health

OTHER

Sponsor Role: collaborator

University of Alberta

OTHER

Sponsor Role: collaborator

University of Toronto

OTHER

Sponsor Role: lead

Responsible Party

Heather Boon

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Heather S Boon, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Toronto

Locations

Riverdale Homeopathic Clinic

Toronto, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 25427521 (View on PubMed)

Other Identifiers

CAM09-213

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

UToronto -25628

Identifier Type: -

Identifier Source: org_study_id