Ignite Creation Date:
2025-12-26 @ 11:12 PM
Ignite Modification Date:
2025-12-26 @ 11:12 PM
Study NCT ID:
NCT00693212
Status:
COMPLETED
Last Update Posted:
2008-06-06
First Post:
2008-06-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Further Studies of Attention Deficit Disorder - Residual Type (RT)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}, {'id': 'D012917', 'term': 'Social Adjustment'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008774', 'term': 'Methylphenidate'}], 'ancestors': [{'id': 'D010648', 'term': 'Phenylacetates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 116}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1986-02'}, 'expandedAccessInfo': {'hasExpandedAccess': True}, 'statusVerifiedDate': '2008-06', 'completionDateStruct': {'date': '1994-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-06-05', 'studyFirstSubmitDate': '2008-06-03', 'studyFirstSubmitQcDate': '2008-06-05', 'lastUpdatePostDateStruct': {'date': '2008-06-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '1994-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Wender-Reimherr Adult Attention Deficit Disorder Scale', 'timeFrame': 'Monthly'}], 'secondaryOutcomes': [{'measure': 'Clinical Global Impression - Improvement', 'timeFrame': 'monthly'}, {'measure': 'The Global Assessment of Functioning (GAF).', 'timeFrame': 'monthly'}, {'measure': 'The Weissman Social Adjustment Scale (WSAS)', 'timeFrame': 'At termination'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ADHD', 'Adult', 'crossover', 'randomized', 'Long-term', 'Open-label', 'methylphenidate', 'Social adjustment'], 'conditions': ['Attention Deficit Hyperactivity Disorder']}, 'descriptionModule': {'briefSummary': 'The first phase was a double-blind crossover design of methylphenidate in the treatment of adult ADHD. The second phase consisted of an open-label extension trial of methylphenidate in adult ADHD. It was hypothesized that methylphenidate would prove more effective than placebo in treating ADHD symptoms during the first phase. It was also hypothesized that methylphenidate responders from the double-blind trial would continue to benefit from treatment in the second phase. Improvement would include both ADHD symptoms and social adjustment.', 'detailedDescription': 'All patients received a single-blind week on placebo, followed by a double-blind random assignment crossover trial of methylphenidate and placebo, with each double-blind phase lasting two weeks. Subjects who experienced moderate or marked improvement on methylphenidate would be allowed to enter a long-term, open-label trial. ADHD symptom severity was measured monthly by a structured interview, the Wender-Reimherr Adult Attention Deficit Disorder Scale (WRAADDS), Clinical Global Impression - Improvement (CGI-I) and Global Assessment of Functioning (GAF). Social functioning was assessed by the clinician administered version of the Weissman Social Adjustment Scale (WSAS). Dosing was determined by clinical judgement, symptom improvement and AEs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages 21-55 years; male and female; met "Utah Criteria" for adult ADHD; 95th or higher percentile on the Parent Rating Scale and/or the Wender Utah Rating Scale;\n\nExclusion Criteria:\n\n* Patients with other axis-I and axis-II diagnoses were excluded as were patients with significant medical problems.'}, 'identificationModule': {'nctId': 'NCT00693212', 'briefTitle': 'Further Studies of Attention Deficit Disorder - Residual Type (RT)', 'organization': {'class': 'OTHER', 'fullName': 'University of Utah'}, 'officialTitle': 'Further Studies of Attention Deficit Disorder - Residual Type', 'orgStudyIdInfo': {'id': 'IRB 1491'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'a', 'description': 'This arm was only open to subjects entering the second, open-label phase. All subjects were given open-label methylphenidate. Dosing was flexible.', 'interventionNames': ['Drug: methylphenidate']}, {'type': 'EXPERIMENTAL', 'label': 'MPH', 'description': 'This is the active treatment arm of the double-blind placebo controlled phase. Patients were begun at 10 mg t.i.d. and the dose increased as necessary until a maximum dose of 60 mg/day was administered. Frequency could be increased and some patients had dosage schedules of 4 to 6 times per day', 'interventionNames': ['Drug: methylphenidate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'PBO', 'description': 'This 2 week arm is the placebo part of the crossover design. Subjects receive placebo in a manner similar to the MPH arm. It lasts 2 weeks.', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'methylphenidate', 'type': 'DRUG', 'otherNames': ['ritalin'], 'description': 'Dosing was flexible and dependent on clinical judgement, AEs and treatment response.', 'armGroupLabels': ['a']}, {'name': 'methylphenidate', 'type': 'DRUG', 'otherNames': ['ritalin'], 'description': 'Patients were begun at 10 mg t.i.d. and the dose increased as necessary until a maximum dose of 60 mg/day was administered. Frequency could be increased and some patients had dosage schedules of 4 to 6 times per day', 'armGroupLabels': ['MPH']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Dosing is identical to the MPH arm except that the pills will contain no active medication.', 'armGroupLabels': ['PBO']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Univ of Utah, School of Medicine, Mood Disorders Clinic', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Paul H Wender, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Utah'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Utah', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'oldNameTitle': 'Paul H. Wender MD Director Mood Disorders Clinic', 'oldOrganization': 'University of Utah; Mood Disorders Clinic'}}}}