Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2025-12-25 @ 11:26 PM
Study NCT ID:
NCT00852059
Status:
TERMINATED
Last Update Posted:
2014-05-07
First Post:
2009-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adherence to Stimulant Treatment in Attention-Deficit Hyperactivity Disorder (ADHD) Patients (ASTA)
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'whyStopped': 'Diffculties to recruit anticipated study size, now analysis', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-06', 'studyFirstSubmitDate': '2009-02-25', 'studyFirstSubmitQcDate': '2009-02-25', 'lastUpdatePostDateStruct': {'date': '2014-05-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Non-adherence assessed by the number of non-adherent days during the clinical trial of 100 days using the Medication Event Monitoring System (MEMS)', 'timeFrame': '100 days'}], 'secondaryOutcomes': [{'measure': 'Number of non-adherent days measured by pill count', 'timeFrame': '100 days'}, {'measure': 'Time interval until a total number of 30 days of non-adherence is reached cumulatively during the clinical trial measured by MEMS', 'timeFrame': '100 days'}, {'measure': 'Quality of life during measured by Child Health Illness Profile - Child Edition (CHIP-CE) Score', 'timeFrame': '100 days'}, {'measure': 'The efficacy of stimulant treatment during the clinical trial measured by ADHD-Rating Scale- Parent Version Sum Score', 'timeFrame': '100 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ADHD', 'children', 'adolescents', 'methylphenidate', 'adherence', 'immediate release', 'extended release', 'efficacy'], 'conditions': ['ADHD']}, 'descriptionModule': {'briefSummary': 'This study determined to measure non-adherence assessed by the number of non-adherent days during the clinical trial of 100 days using the Medication Event Monitoring System (MEMS).\n\nStudy Design:\n\n* prospective\n* multi-centric\n* open-label\n* randomized\n* active-controlled trial', 'detailedDescription': 'The study is designed as a prospective, multi-centric, open-label, randomized, active-controlled trial. ADHD-children and adolescents of both sexes, 6-17 of age, effectively treated with stimulants are recruited in two centres. Over a naturalistic run-in phase of four weeks adherence to medication taken before randomisation is measured. In the subsequent controlled clinical trial 50% of the participants are randomized to extended release (ER) methylphenidate (Medikinet retard®) applied with breakfast, 50% are randomized to immediate release (IR) methylphenidate (Medikinet®) in the morning and 3-4 h later (clinical trial). To optimize ecological validity, no double-dummy technique is applied; the allocation to either study arm is non-blinded.\n\nAccording to the power calculation 106 patients will be randomized. The total duration of the study is 18 months. Starting with a run-in visit, each eligible patient is observed in the naturalistic run-in phase for four weeks. Subsequently, patients participate 100 days in the clinical trial starting with a baseline visit, an in between-visit and a final visit. Medical care is provided in the routine program of both study centres. To record the adherence, medication events are counted by Medication Event Monitoring System (MEMS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent (separately for children aged 6-11 years and 12-17 years)\n* Children and adolescents of both sexes aged 6 - 17 years\n* Confirmed diagnosis of ADHD by semi structured-clinical interview K-SADS\n* ADHDRS-IV-Parent Version (18-Item-Scale) raw score ≥ 1,5 SD above norm under non-medicated conditions (either drug holiday or prior to medication within the past 6 months)\n* Effective treatment with a stable dose of methylphenidate for at least one month (max. 60 mg/day) proved by a 25% symptom reduction in ADHD-RS under medication, compared to retrospective ADHD-RS without medication within the past 6 months.\n* Acceptance and capability to swallow capsules of product size, proved by an equally sized placebo provided by Medice®.\n* Sufficient knowledge of the German language\n* Adequate contraception in case of sexual activity\n\nExclusion Criteria:\n\n* Contraindications against methylphenidate\n* Previous stable methylphenidate intake more than twice daily\n* All severe psychiatric disorders except oppositional defiant disorder (ODD) or conduct disorder. In order to reflect the usual co-morbid spectrum of ADHD, mild or moderate anxiety or depressive disorders are accepted in the study.\n* All severe somatic diseases as assessed by the baseline examination or medical history (including life-time history of epileptic disorders)\n* Pathological results for vital signs, blood pressure and pulse\n* Reported pathological results for ECG during the last 12 months\n* Reported pathological results for differential blood count and hepatic metabolism during the last 6 months\n* Indication for hospitalization\n* Suicidality (assessed by MADRS Item 10, Score ≥ 3)\n* IQ \\< 70 (clinically assessed)\n* Any psychotropic co-medication\n* Detention in an institution on official or judicial ruling\n* Unwillingness to transmit pseudonym data according to German regulations\n* Simultaneous participation in another clinical trial according to German Drug Law (AMG)'}, 'identificationModule': {'nctId': 'NCT00852059', 'acronym': 'ASTA', 'briefTitle': 'Adherence to Stimulant Treatment in Attention-Deficit Hyperactivity Disorder (ADHD) Patients (ASTA)', 'organization': {'class': 'OTHER', 'fullName': 'Johannes Gutenberg University Mainz'}, 'officialTitle': "Effect of Methylphenidate Formulation on ADHD-patients' Adherence to Medical Treatment. A Comparison of Medikinet Retard® (ER) Once Daily and Medikinet® (IR) Twice Daily in Children and Adolescents Diagnosed With ADHD", 'orgStudyIdInfo': {'id': 'JoGu_KJP_ASTA-3285-26'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Immediate release', 'description': 'Treatment with immediate release (IR) methylphenidate (Medikinet®) in the morning and 3-4 h later (twice a day)', 'interventionNames': ['Drug: Immediate release methylphenidate (Medikinet®)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Extended release', 'description': 'Treatment with extended release (ER) methylphenidate (Medikinet reatard®) applied with breakfast(once daily)', 'interventionNames': ['Drug: Extended release methylphenidate (Medikinet retard®)']}], 'interventions': [{'name': 'Immediate release methylphenidate (Medikinet®)', 'type': 'DRUG', 'otherNames': ['Medikinet®'], 'description': 'Treatment: methylphenidate in the morning and 3-4 h later (twice daily), immediate release', 'armGroupLabels': ['Immediate release']}, {'name': 'Extended release methylphenidate (Medikinet retard®)', 'type': 'DRUG', 'otherNames': ['Medikinet retard®'], 'description': 'Treatment: methylphenidate applied with breakfast(once daily), extended release', 'armGroupLabels': ['Extended release']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55131', 'city': 'Mainz', 'country': 'Germany', 'facility': 'Universitätsmedizin der Johannes Gutenberg-Universität Mainz - Körperschaft des öffentlichen Rechts', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}], 'overallOfficials': [{'name': 'Michael Huss, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johannes Gutenberg University, Mainz, Dep. of Child and Adolescent Psychiatry'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prof. Huss', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. Michael Huss', 'investigatorFullName': 'Prof. Huss', 'investigatorAffiliation': 'Johannes Gutenberg University Mainz'}}}}