A Pilot Trial of Homeopathic Treatment for Attention Deficit Hyperactivity Disorder

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01141634
• Other study ID #: UToronto -25628
• Secondary ID: CAM09-213
• Status: Completed
• Phase: Phase 2
• First received: June 8, 2010
• Last updated: March 6, 2014
• Start date: June 2010
• Est. completion date: December 2012

Study information

• Verified date: March 2014
• Source: University of Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 16 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Disease
• Hyperkinesis

Intervention

Other:
• Homeopathic Remedies
Homeopathic remedies prepared according to the standards as set out by Health Canada

Locations

Country	Name	City	State
Canada	Riverdale Homeopathic Clinic	Toronto	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
University of Toronto	Centre for Addiction and Mental Health, SickKids Foundation, University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Conners 3-Parent		36 weeks	No
Secondary	MYMOP2		36 weeks	No