A Placebo Controlled Study of Homeopathic Treatment of Children and Youth With ADHD
Status:
Active, not recruiting
Trial end date:
2021-09-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
University of Toronto
Collaborators:
Centre for Addiction and Mental Health Lotte & John Hecht Memorial Foundation