Ignite Creation Date:
2025-12-24 @ 1:50 PM
Ignite Modification Date:
2026-01-02 @ 2:40 AM
Study NCT ID:
NCT00100295
Status:
COMPLETED
Last Update Posted:
2007-10-26
First Post:
2004-12-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Herbal Treatment for Attention Deficit Hyperactivity Disorder (ADHD)
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': 'C422326', 'term': 'Hypericum extract LI 160'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-10', 'completionDateStruct': {'date': '2006-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-10-24', 'studyFirstSubmitDate': '2004-12-28', 'studyFirstSubmitQcDate': '2004-12-28', 'lastUpdatePostDateStruct': {'date': '2007-10-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-12-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ADHD-IV rating scale', 'timeFrame': 'Difference between baseline and end of study'}, {'measure': 'side effects scale', 'timeFrame': 'Freqency of events during entire study'}], 'secondaryOutcomes': [{'measure': 'Child Behavior Checklist, Youth Self Report Form', 'timeFrame': 'Baseline and end of study'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Adolescent', 'Child', 'Phytotherapy'], 'conditions': ['Attention Deficit Hyperactivity Disorder']}, 'referencesModule': {'references': [{'pmid': '18544723', 'type': 'DERIVED', 'citation': "Weber W, Vander Stoep A, McCarty RL, Weiss NS, Biederman J, McClellan J. Hypericum perforatum (St John's wort) for attention-deficit/hyperactivity disorder in children and adolescents: a randomized controlled trial. JAMA. 2008 Jun 11;299(22):2633-41. doi: 10.1001/jama.299.22.2633."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the safety and effectiveness of an herbal product for the treatment of attention deficit hyperactivity disorder (ADHD) in children and adolescents.', 'detailedDescription': 'ADHD is a common childhood disorder associated with concentration problems and disruptive behavior. Evidence suggests that herbal remedies may be as effective as standard drug therapies in treating ADHD symptoms. This study will determine the safety and efficacy of an herbal treatment in children and adolescents with ADHD.\n\nThis study will last 9 weeks. Participants will be randomly assigned to receive either an herbal product or placebo three times a day for the duration of the study. Participants will come in for weekly study visits at which their ADHD symptoms and any side effects will be assessed by self-report rating scales.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of ADHD\n* Score of greater than 1.5 standard deviation above the age and gender norms on the ADHD-IV rating scale\n* Parents and children can understand English\n* Parents and children willing to attend all study visits\n* Able to swallow study medication\n* Willing to use acceptable methods of contraception\n\nExclusion Criteria:\n\n* Severe depression\n* History of bipolar disorder, psychosis, severe conduct disorder, or other serious medical conditions\n* Use of medications that may interact with the herbal product\n* Current use of medications to treat ADHD\n* Previous use of Hypericum\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT00100295', 'briefTitle': 'Herbal Treatment for Attention Deficit Hyperactivity Disorder (ADHD)', 'organization': {'class': 'NIH', 'fullName': 'National Center for Complementary and Integrative Health (NCCIH)'}, 'officialTitle': 'Controlled Trial of an Herbal Treatment for Juvenile Attention Deficit Hyperactivity Disorder', 'orgStudyIdInfo': {'id': 'K23AT000929', 'link': 'https://reporter.nih.gov/quickSearch/K23AT000929', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'Herbal treatment', 'interventionNames': ['Drug: Hypericum perforatum']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'B', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Hypericum perforatum', 'type': 'DRUG', 'otherNames': ["St. John's Wort"], 'description': '300 mg capsule taken three times a day', 'armGroupLabels': ['A']}, {'name': 'Placebo', 'type': 'OTHER', 'description': '300 mg given three times a day, containing rice protein powder', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98028', 'city': 'Kenmore', 'state': 'Washington', 'country': 'United States', 'facility': 'Bastyr University', 'geoPoint': {'lat': 47.75732, 'lon': -122.24401}}], 'overallOfficials': [{'name': 'Wendy Weber, ND, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bastyr University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Center for Complementary and Integrative Health (NCCIH)', 'class': 'NIH'}}}}