Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-30 @ 4:27 AM
Study NCT ID:
NCT01141634
Status:
COMPLETED
Last Update Posted:
2014-03-07
First Post:
2010-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pilot Trial of Homeopathic Treatment for Attention Deficit Hyperactivity Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008419', 'term': 'Materia Medica'}], 'ancestors': [{'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-06', 'studyFirstSubmitDate': '2010-06-08', 'studyFirstSubmitQcDate': '2010-06-08', 'lastUpdatePostDateStruct': {'date': '2014-03-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Conners 3-Parent', 'timeFrame': '36 weeks'}], 'secondaryOutcomes': [{'measure': 'MYMOP2', 'timeFrame': '36 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Attention Deficit Hyperactivity Disorder', 'Attention Deficit Disorder', 'ADHD', 'ADD', 'Homeopathy'], 'conditions': ['Attention Deficit Hyperactivity Disorder']}, 'referencesModule': {'references': [{'pmid': '25427521', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Males and females aged 6-16 diagnosed with ADHD of any subtype according to DSM-IV criteria.\n* Mentally competent participants able to adhere to the given protocol and treatments administered as interventions, and able to answer outcome measures.\n* Primary caregiver (parent or guardian) has given informed consent; child participant gives ongoing assent throughout the study.\n\nExclusion Criteria:\n\n* Changes to participants' medication for ADHD within 6 weeks of study onset.\n* 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.\n* Participants should have no history of head injury of seizures, organ system damage and should have an estimated I.Q within the normal range.\n* Pregnancy and Lactation"}, 'identificationModule': {'nctId': 'NCT01141634', 'briefTitle': 'A Pilot Trial of Homeopathic Treatment for Attention Deficit Hyperactivity Disorder', 'organization': {'class': 'OTHER', 'fullName': 'University of Toronto'}, 'officialTitle': 'A Pilot Trial of Homeopathic Treatment for Attention Deficit Hyperactivity Disorder in Children and Adolescents', 'orgStudyIdInfo': {'id': 'UToronto -25628'}, 'secondaryIdInfos': [{'id': 'CAM09-213', 'type': 'OTHER_GRANT', 'domain': 'SickKids Foundation'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Homeopathic Remedies', 'type': 'OTHER', 'description': 'Homeopathic remedies prepared according to the standards as set out by Health Canada'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M4J 1N1', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Riverdale Homeopathic Clinic', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Heather S Boon, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Toronto'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Toronto', 'class': 'OTHER'}, 'collaborators': [{'name': 'SickKids Foundation', 'class': 'OTHER'}, {'name': 'Centre for Addiction and Mental Health', 'class': 'OTHER'}, {'name': 'University of Alberta', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Heather Boon', 'investigatorAffiliation': 'University of Toronto'}}}}