Clinical trial NCT01141634: A Pilot Trial of Homeopathic Treatment for Attention Deficit Hyperactivity Disorder
Official title: A Pilot Trial of Homeopathic Treatment for Attention Deficit Hyperactivity Disorder in Children and Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: Attention Deficit Hyperactivity Disorder
Attention Deficit Disorder
ADHD
ADD
Homeopathy
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: SickKids Foundation
name: Centre for Addiction and Mental Health
name: University of Alberta
First posted: 2010-06-10
Enrollment: 36
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Conners 3-Parent
timeFrame: 36 weeks
Secondary outcomes:
measure: MYMOP2
timeFrame: 36 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Riverdale Homeopathic Clinic
state: Ontario
Study officials:
affiliation: University of Toronto
name: Heather S Boon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.