Attention Deficit Hyperactivity DisorderPhase 2NCT02086864
A Placebo Controlled Study of Homeopathic Treatment of Children and Youth With ADHD
A Phase 2 study testing lactose/sucrose granule (Individualized homeopathic medicine treatment) and Homeopathic consultation in people with Attention Deficit Hyperactivity Disorder, run by University of Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- lactose/sucrose granule (Individualized homeopathic medicine treatment) and Homeopathic consultation
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 151 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2014to Aug 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double Blind, Placebo Controlled Study of Homeopathic Treatment of Children and Youth With Attention Deficit Hyperactivity Disorder
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.
Read more
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
- Being tested
- lactose/sucrose granule (Individualized homeopathic medicine treatment), Placebo lactose/sucrose pill, Homeopathic consultation
- Keywords
- Attention Deficit Hyperactivity Disorder, ADHD, Homeopathy
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Placebo lactose/sucrose pillDrug
Homeopathic consultationBehavioural
Also called Homeopathic case taking (90 minutes)
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | Not described |
| 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. Receives: 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. Receives: Drug: Placebo lactose/sucrose pill; Behavioral: Homeopathic consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Conners 3 Global Index - Parent
Measured: Baseline and weeks 8, 20, 28
Secondary outcomes (10)
Change from baseline in Conners ADHD Index Probability score
Measured: Baseline and weeks 8, 20, 28
Change from baseline in Conners Content Scale for Inattention and Hyperactivity/Impulsivity
Measured: 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
Measured: Baseline and weeks 8, 20, 28
Clinical Global Impression-Improvement scale
Measured: Week 28
Change from baseline in the Pediatric Quality of Life Inventory
Measured: Baseline and weeks 8, 20, 28
Change from baseline in Consultation and Relational Empathy measure
Measured: Baseline and weeks 8, 20, 28
Change from baseline in RTI Provider Support Measure
Measured: Baseline and weeks 8, 20, 28
Change from baseline in the Resiliency Scales for Children & Adolescents - Mastery sub-scale
Measured: Baseline and weeks 8, 20, 28
Change from baseline in Coping Efficacy Scale
Measured: Baseline and weeks 8, 20, 28
Change from baseline in Control Beliefs Inventory - Mastery sub-scale
Measured: Baseline and weeks 8, 20, 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionMar 2021
- Study completionAug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Lotte & John Hecht Memorial Foundation, Centre for Addiction and Mental Health
- Responsible party
- Principal investigator, Heather Boon, University of Toronto
- Investigators
- Heather Boon, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02086864
- Sponsor's protocol ID
- UToronto-29722
- Other IDs
- 079-2013
- Status last verified
- May 2024
- First submitted
- 7 Mar 2014
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 37672605
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo Controlled Study of Homeopathic Treatment of Children and Youth With Attention Deficit Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT02086864
- Acronym / sponsor ID
- UToronto-29722
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- Attention Deficit Hyperactivity Disorder, ADHD, Homeopathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Lotte & John Hecht Memorial Foundation, Centre for Addiction and Mental Health
- Study start
- Mar 2014 (actual)
- Primary completion
- Mar 2021 (actual)
- Study completion
- Aug 2023 (actual)
- First posted
- 13 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | – |
| Individualized homeopathic medicine treatment | Active comparator | Drug: lactose/sucrose granule (Individualized homeopathic medicine treatment), Behavioral: Homeopathic consultationParticipant will have a homeopathic consultation and be given a homeopathic medicine. Homeopathic medicines are chosen from those available for sale in Canada. |
| Unmedicated lactose/sucrose pill | Placebo comparator | Drug: Placebo lactose/sucrose pill, Behavioral: Homeopathic consultationParticipant will receive a homeopathic consultation and receive an unmedicated lactose/sucrose pill. |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Individualized homeopathic medicine treatment |
| Placebo lactose/sucrose pill | Drug | Unmedicated lactose/sucrose pill |
| Homeopathic consultationAlso: Homeopathic case taking (90 minutes) | Behavioural | Individualized homeopathic medicine treatment, Unmedicated lactose/sucrose pill |
Primary outcome
Change from baseline in Conners 3 Global Index - Parent
Time frame: Baseline and weeks 8, 20, 28
10 secondary outcomes
Change from baseline in Conners ADHD Index Probability score
Time frame: Baseline and weeks 8, 20, 28
Change from baseline in Conners Content Scale for Inattention and Hyperactivity/Impulsivity
Time frame: 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
Time frame: Baseline and weeks 8, 20, 28
Clinical Global Impression-Improvement scale
Time frame: Week 28
Change from baseline in the Pediatric Quality of Life Inventory
Time frame: Baseline and weeks 8, 20, 28
Change from baseline in Consultation and Relational Empathy measure
Time frame: Baseline and weeks 8, 20, 28
Change from baseline in RTI Provider Support Measure
Time frame: Baseline and weeks 8, 20, 28
Change from baseline in the Resiliency Scales for Children & Adolescents - Mastery sub-scale
Time frame: Baseline and weeks 8, 20, 28
Change from baseline in Coping Efficacy Scale
Time frame: Baseline and weeks 8, 20, 28
Change from baseline in Control Beliefs Inventory - Mastery sub-scale
Time frame: Baseline and weeks 8, 20, 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Derived from this study: PubMed 37672605Brule 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather Boon, PhD principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing lactose/sucrose granule (Individualized homeopathic medicine treatment) and Homeopathic consultation in people with Attention Deficit Hyperactivity Disorder, run by University of Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Conners 3 Global Index - Parent (time frame: Baseline and weeks 8, 20, 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02086864, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2024.