Ignite Creation Date:
2025-12-25 @ 1:07 AM
Ignite Modification Date:
2026-01-04 @ 3:45 AM
Study NCT ID:
NCT01835093
Status:
COMPLETED
Last Update Posted:
2014-02-21
First Post:
2013-04-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Open Study of Tipepidine Hibenzate in Patients With 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': 'C028458', 'term': 'tipepidine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-19', 'studyFirstSubmitDate': '2013-04-16', 'studyFirstSubmitQcDate': '2013-04-16', 'lastUpdatePostDateStruct': {'date': '2014-02-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ADHD Rating Scale-IV (ADHD-RS) Japanese Version', 'timeFrame': 'Changes from baseline in ADHD-RS at 4-weeks', 'description': 'The ADHD Rating Scale-IV obtains parent ratings regarding the frequency of each ADHD symptom based on DSM-IV criteria.\n\nThe ADHD Rating Scale-IV is completed independently by the parent and scored by a clinician. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items).'}], 'secondaryOutcomes': [{'measure': 'Cognition using DN-CAS (Das-Naglieri Cognitive Assessment System) Japanese Version', 'timeFrame': 'Change from baseline in the scores of battery at 4-weeks', 'description': 'The DN-CAS is an assessment battery designed to evaluate cognitive processing. It was developed to integrate theoretical and applied areas of psychological knowledge using cognitive processing theory and tests designed to measure-Planning, Attention, Simultaneous, and Successive Processing (PASS)-in individuals ages 5-17.\n\nThis assessment facilitates mental health professionals in the identification of Attention-Deficit/Hyperactivity Disorder, Traumatic Brain Injury, learning disabilities, Mental Retardation, and giftedness.'}]}, 'conditionsModule': {'conditions': ['Attention Deficit Disorder With Hyperactivity']}, 'referencesModule': {'references': [{'pmid': '24493927', 'type': 'RESULT', 'citation': 'Sasaki T, Hashimoto K, Tachibana M, Kurata T, Okawada K, Ishikawa M, Kimura H, Komatsu H, Ishikawa M, Hasegawa T, Shiina A, Hashimoto T, Kanahara N, Shiraishi T, Iyo M. Tipepidine in children with attention deficit/hyperactivity disorder: a 4-week, open-label, preliminary study. Neuropsychiatr Dis Treat. 2014 Jan 24;10:147-51. doi: 10.2147/NDT.S58480. eCollection 2014.'}]}, 'descriptionModule': {'briefSummary': 'Accumulating evidence suggests a role of G protein-coupled inwardly-rectifying potassium (GIRK) channel in the pathology of excitement of nerve, and the medicine with the action (like the Tipepidine Hibenzate) is expected as a new curative medicine of Attention Deficit / Hyperactivity Disorder (AD/HD).\n\nThe purpose of this research is to confirm the effect by carrying out the additional dosage of the Tipepidine Hibenzate to the AD/HD patients.\n\nIf suggestion is obtained by this research about the effect on AD/HD of Tipepidine Hibenzate, it can contribute to development of the medical treatment of AD/HD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '\\[Inclusion Criteria\\]\n\n1. Attention-Deficit/Hyperactivity Disorder (AD/HD) for DSM-IV TR criteria.\n2. Patients are treated with Atomoxetine, Methylphenidate, atypical antipsychotic drugs (risperidone, olanzapine, quetiapine, perospirone, aripiprazole, blonanserin, paliperidone) or not treated.\n3. Patients are stable for 4-weeks for medication.\n\n\\[Exclusion Criteria\\]\n\n1. Patients with a previous hypersensitivity to Tipepidine Hibenzate.\n2. Patients treated with typical antipsychotics and selective norepinephrine reuptake inhibitor (NRI) except atomoxetine and stimulants except methylphenidate.\n3. Pregnant or breast-feeding women'}, 'identificationModule': {'nctId': 'NCT01835093', 'briefTitle': 'An Open Study of Tipepidine Hibenzate in Patients With Attention Deficit Hyperactivity Disorder (ADHD)', 'organization': {'class': 'OTHER', 'fullName': 'Chiba University'}, 'officialTitle': 'Tipepidine for ADHD', 'orgStudyIdInfo': {'id': 'G24061'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A single-arm study', 'interventionNames': ['Drug: Tipepidine Hibenzate']}], 'interventions': [{'name': 'Tipepidine Hibenzate', 'type': 'DRUG', 'armGroupLabels': ['A single-arm study']}]}, 'contactsLocationsModule': {'locations': [{'zip': '260-8670', 'city': 'Chiba', 'state': 'Chuo-ku', 'country': 'Japan', 'facility': 'Department of Psychiatry, Chiba University School of Medicine', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}], 'overallOfficials': [{'name': 'Masaomi Iyo, MD,PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Chairman, Department of Psychiatry, Chiba University Graduate School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chiba University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Tsuyoshi Sasaki', 'investigatorAffiliation': 'Chiba University'}}}}