NCT02086864

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
151

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2014

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

March 7, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 13, 2014

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

May 14, 2024

Status Verified

May 1, 2024

Enrollment Period

7 years

First QC Date

March 7, 2014

Last Update Submit

May 12, 2024

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

Attention Deficit Hyperactivity DisorderADHDHomeopathy

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in Conners 3 Global Index - Parent

    Baseline and weeks 8, 20, 28

Secondary Outcomes (10)

  • Change from baseline in Conners ADHD Index Probability score

    Baseline and weeks 8, 20, 28

  • Change from baseline in Conners Content Scale for Inattention and Hyperactivity/Impulsivity

    Baseline and weeks 8, 20, 28

  • Change from baseline in Conners DSM-IV-TR Symptom Scale for the ADHD Inattentive and ADHD Hyperactive-Impulsive subtypes

    Baseline and weeks 8, 20, 28

  • Clinical Global Impression-Improvement scale

    Week 28

  • Change from baseline in the Pediatric Quality of Life Inventory

    Baseline and weeks 8, 20, 28

  • +5 more secondary outcomes

Study Arms (3)

Usual care

NO INTERVENTION

Individualized homeopathic medicine treatment

ACTIVE COMPARATOR

Participant will have a homeopathic consultation and be given a homeopathic medicine. Homeopathic medicines are chosen from those available for sale in Canada.

Drug: lactose/sucrose granule (Individualized homeopathic medicine treatment)Behavioral: Homeopathic consultation

Unmedicated lactose/sucrose pill

PLACEBO COMPARATOR

Participant will receive a homeopathic consultation and receive an unmedicated lactose/sucrose pill.

Drug: Placebo lactose/sucrose pillBehavioral: Homeopathic consultation

Interventions

lactose/sucrose granule (Individualized homeopathic medicine treatment)DRUG

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.

Individualized homeopathic medicine treatment
Placebo lactose/sucrose pillDRUG
Unmedicated lactose/sucrose pill
Homeopathic consultationBEHAVIORAL
Also known as: Homeopathic case taking (90 minutes)
Individualized homeopathic medicine treatmentUnmedicated lactose/sucrose pill

Eligibility Criteria

Age6 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • have a diagnosis of attention deficit hyperactivity disorder (and any of the subtypes of the diagnosis) confirmed by study psychiatrist
  • have a minimum baseline score on the Connors 3 scale that is 1.5 standard deviations above the population norm based in the age and sex of the participant as was reported to be most commonly used in ADHD treatment trials
  • are between 6 and 16 years of age
  • are able to ingest medications in liquid or in lactose/sucrose granule form;
  • if currently taking stimulant therapy for ADHD, are on a stable dose for a minimum of 6 weeks prior to beginning the study
  • have an estimated I.Q. within the normal range
  • have parents/guardians who are able to read and write in English

You may not qualify if:

  • a diagnosis with an additional mental health disorder including, but not limited to, the following: Conduct Disorder, Autism Spectrum Disorder, Bipolar Disorder, and Major Depressive Disorder
  • any significant suicidality
  • an addiction to any substance
  • taking any other prescription medication aside from a stable dose of ADHD medication
  • a history of head injury (with sequelae), seizures, or organ system damage
  • pregnant or lactating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riverdale Homeopathic Clinic

Toronto, Ontario, M4J 1N1, Canada

Location

Related Publications (1)

  • Brule D, Landau-Halpern B, Nastase V, Zemans M, Mitsakakis N, Boon H. A Randomized Three-Arm Double-Blind Placebo-Controlled Study of Homeopathic Treatment of Children and Youth with Attention-Deficit/Hyperactivity Disorder. J Integr Complement Med. 2024 Mar;30(3):279-287. doi: 10.1089/jicm.2023.0043. Epub 2023 Sep 6.

    PMID: 37672605DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

LactoseSucrose

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

DisaccharidesOligosaccharidesPolysaccharidesCarbohydratesSugars

Study Officials

  • Heather Boon, PhD

    University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 7, 2014

First Posted

March 13, 2014

Study Start

March 1, 2014

Primary Completion

March 1, 2021

Study Completion

August 1, 2023

Last Updated

May 14, 2024

Record last verified: 2024-05

Locations

CA(1)