A Placebo Controlled Study of Homeopathic Treatment of Children and Youth With ADHD

Summary

Attention Deficit Hyperactivity Disorder (ADHD) is a developmental disorder that presents during childhood, with at least some symptoms causing impairment before the age of seven. It is characterized by developmentally inappropriate levels of inattention and/or hyperactive-impulsive behavior, with significant impairment occurring in at least two settings. It affects approximately 5.2 million children in the United States. Homeopathic treatment has been shown to be a promising intervention for ADHD, however the reasons for that effectiveness is unclear. Specifically, it is unclear whether improvement is due to the homeopathic medicine, the consultative process, or other non-specific effects.

This study has 3 primary objectives: 1. to determine if there are any specific effects of homeopathic medicines in the treatment of ADHD, 2. to determine if there any specific effects the homeopathic consultation alone in the treatment of ADHD, and 3. to determine if there is an overall effect of homeopathic treatment (homeopathic medicines plus consultation) in the treatment of ADHD.

This is a three arm study. Participants will be randomized to one of three arms:

Arm 1 (Verum group): a treatment arm where the participant will receive homeopathic consultation plus a homeopathic remedy Arm 2 (Placebo group): a treatment arm where the participant will receive homeopathic consultation plus a placebo remedy Arm 3 (Usual care group): participants will continue with usual care and will not receive homeopathic treatment as part of the study.

Participants enrolled in this study, regardless of which study Arm they are in, may continue with all conventional medications or any other aspect of their current standard of care they are taking as recommended by their usual physician (so long as they are on a stable dose of the conventional ADHD medication for at least 6 weeks prior to beginning the trial). They may also continue to attend regularly scheduled visits with their own health care practitioner(s).

Participants may also start, stop or change the dose of any therapy (including conventional medications) during the study and are asked to report the change to the study team. Thus, the placebo group participants are not different than other participants, except that they will have a homeopathic consultation and a placebo remedy. The use of placebo is specific to homeopathic treatment, to allow for double-blinding, which is recognized to reduce study bias.

Prior to enrolling in the study, those considering participation will undergo a full assessment by a psychiatrist with a specialty in child and youth mental health. This assessment confirms the diagnosis and screens for inclusion/exclusion study criteria. At the same time, the psychiatrist recommends evidence-based therapies to clients including conventional medication. The psychiatrist does not directly treat the client. If medication is recommended and the clients wish to pursue it with their regular physician, they would still be able to enroll in the study if they wanted to, after six weeks of reaching a stable dose.

This study will help our understanding of the treatment process and whether different elements of the intervention have greater or lesser effects.

This study is a follow-up to an open label pilot study of the homeopathic treatment of ADHD using the same study team. Sample size was calculated based on the results of that study.

Conditions

• Attention Deficit Hyperactivity Disorder

Interventions

DRUG

lactose/sucrose granule (Individualized homeopathic medicine treatment)

The homeopathic remedy (study medication) for each patient will be chosen from among the homeopathic medicines manufactured by Boiron Canada and currently approved for sale in Canada by Health Canada. As per classical homeopathy practice, once the most appropriate homeopathic remedy has been chosen, it will be prescribed by the homeopath according to her/his clinical judgment (maximum on a daily basis, 3 times per day, minimum 1 dose (or zero doses on the second consult or later)) with administration instructions given to the parent and patient as appropriate. Water dosing, in which a lactose/sucrose granule remedy is dissolved in 250 ml of water will be used based on the homeopath's clinical judgment. Only one remedy will be administered at a time.

DRUG

Placebo lactose/sucrose pill

BEHAVIORAL

Homeopathic consultation

Sponsors & Collaborators

• Lotte & John Hecht Memorial Foundation

  collaborator OTHER

• Centre for Addiction and Mental Health

  collaborator OTHER

• University of Toronto

  lead OTHER

Principal Investigators

• Heather Boon, PhD · University of Toronto

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

6 Years

Max Age

16 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-03-31

Primary Completion

2021-03-31

Completion

2023-08-31

Countries

• Canada

Study Locations