Ignite Creation Date:
2025-12-24 @ 3:40 PM
Ignite Modification Date:
2025-12-25 @ 1:50 PM
Study NCT ID:
NCT00428792
Status:
COMPLETED
Last Update Posted:
2011-05-06
First Post:
2007-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of Methylphenidate in Children With Attention-deficit Hyperactivity Disorder (ADHD)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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': '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '862 778-8300', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'Safety population: All randomized patients who took at least 1 dose of study drug in 1 of the 2 treatment periods.', 'eventGroups': [{'id': 'EG000', 'title': 'Very Light Breakfast (VLB) Then Standard Breakfast (SB)', 'description': 'Very light breakfast (VLB) for one week then crossover to standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.', 'otherNumAtRisk': 148, 'otherNumAffected': 0, 'seriousNumAtRisk': 148, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Standard Breakfast (SB) Then Very Light Breakfast (VLB)', 'description': 'Standard breakfast (SB) for one week then crossover to very light breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.', 'otherNumAtRisk': 149, 'otherNumAffected': 0, 'seriousNumAtRisk': 149, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Teacher Rating in the Intent-to-Treat (ITT) Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Very Light Breakfast (VLB) Treatment Group', 'description': 'Very Light Breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.'}, {'id': 'OG001', 'title': 'Standard Breakfast (SB) Treatment Group', 'description': 'Standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.97', 'spread': '0.63', 'groupId': 'OG000'}, {'value': '1.01', 'spread': '0.63', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Friday of each of the 2 treatment weeks', 'description': 'The FBB-ADHS is a 20-item rating scale. Each item describes a typical ADHD symptom. The 20 items are divided into 3 subscales: Attention deficits (9 items), hyperactivity (7 items), and impulsiveness (4 items). Each item is rated on a scale of 0 = not at all up to 3 = very much. The FBB-ADHS was completed by teachers on Friday afternoon of each week of the study. A total score (sum of all items divided by 20) was calculated. The total score can range from 0 to 3. A lower score indicates more ADHD.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat (ITT) population: All randomized patients with at least one post-baseline measurement of the primary endpoint in both study periods.'}, {'type': 'SECONDARY', 'title': 'Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Attention Deficit Subscale Teacher Rating', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Very Light Breakfast (VLB) Treatment Group', 'description': 'Very Light Breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.'}, {'id': 'OG001', 'title': 'Standard Breakfast (SB) Treatment Group', 'description': 'Standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.19', 'spread': '0.68', 'groupId': 'OG000'}, {'value': '1.23', 'spread': '0.69', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Friday of each of the 2 treatment weeks', 'description': 'Teacher rating of the attention deficit subscale (9 items), one of 3 subscales in the FBB-ADHS. Each item is rated on a scale of 0 = not at all up to 3 = very much. The rating was completed by teachers on Friday afternoon of each week of the study. A total score (sum of all items divided by 9) was calculated. The total score can range from 0 to 3. A lower score indicates more ADHD.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat (ITT) population: All randomized patients with at least one post-baseline measurement of the primary endpoint in both study periods.'}, {'type': 'SECONDARY', 'title': 'Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Hyperactivity Subscale Teacher Rating', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Very Light Breakfast (VLB) Treatment Group', 'description': 'Very Light Breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.'}, {'id': 'OG001', 'title': 'Standard Breakfast (SB) Treatment Group', 'description': 'Standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.72', 'spread': '0.70', 'groupId': 'OG000'}, {'value': '0.75', 'spread': '0.69', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Friday of each of the 2 treatment weeks', 'description': 'Teacher rating of the hyperactivity subscale (7 items), one of 3 subscales in the FBB-ADHS. Each item is rated on a scale of 0 = not at all up to 3 = very much. The rating was completed by teachers on Friday afternoon of each week of the study. A total score (sum of all items divided by 7) was calculated. The total score can range from 0 to 3. A lower score indicates more ADHD.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat (ITT) population: All randomized patients with at least one post-baseline measurement of the primary endpoint in both study periods.'}, {'type': 'SECONDARY', 'title': 'Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Impulsiveness Subscale Teacher Rating', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Very Light Breakfast (VLB) Treatment Group', 'description': 'Very Light Breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.'}, {'id': 'OG001', 'title': 'Standard Breakfast (SB) Treatment Group', 'description': 'Standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.93', 'spread': '0.92', 'groupId': 'OG000'}, {'value': '0.99', 'spread': '0.90', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Friday of each of the 2 treatment weeks', 'description': 'Teacher rating of the hyperactivity subscale (4 items), one of 3 subscales in the FBB-ADHS. Each item is rated on a scale of 0 = not at all up to 3 = very much. The rating was completed by teachers on Friday afternoon of each week of the study. A total score (sum of all items divided by 4) was calculated. The total score can range from 0 to 3. A lower score indicates more ADHD.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat (ITT) population: All randomized patients with at least one post-baseline measurement of the primary endpoint in both study periods.'}, {'type': 'SECONDARY', 'title': 'Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Parent Rating', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Very Light Breakfast (VLB) Treatment Group', 'description': 'Very Light Breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.'}, {'id': 'OG001', 'title': 'Standard Breakfast (SB) Treatment Group', 'description': 'Standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.15', 'spread': '0.60', 'groupId': 'OG000'}, {'value': '1.11', 'spread': '0.55', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Saturday of each of the 2 treatment weeks', 'description': 'The FBB-ADHS is a 20-item rating scale. Each item describes a typical ADHD symptom. The 20 items are divided into 3 subscales: Attention deficits (9 items), hyperactivity (7 items), and impulsiveness (4 items). Each item is rated on a scale of 0 = not at all up to 3 = very much. The FBB-ADHS was completed by teachers on Friday afternoon of each week of the study. A total score (sum of all items divided by 20) was calculated. The total score can range from 0 to 3. A lower score indicates more ADHD.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat (ITT) population: All randomized patients with at least one post-baseline measurement of the primary endpoint in both study periods.'}, {'type': 'PRIMARY', 'title': 'Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Teacher Rating in the Per Protocol (PP) Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Very Light Breakfast (VLB) Treatment Group', 'description': 'Very Light Breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.'}, {'id': 'OG001', 'title': 'Standard Breakfast (SB) Treatment Group', 'description': 'Standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.93', 'spread': '0.62', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '0.63', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Friday of each of the 2 treatment weeks', 'description': 'The FBB-ADHS is a 20-item rating scale. Each item describes a typical ADHD symptom. The 20 items are divided into 3 subscales: Attention deficits (9 items), hyperactivity (7 items), and impulsiveness (4 items). Each item is rated on a scale of 0 = not at all up to 3 = very much. The FBB-ADHS was completed by teachers on Friday afternoon of each week of the study. A total score (sum of all items divided by 20) was calculated. The total score can range from 0 to 3. A lower score indicates more ADHD.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol (PP) population: All patients in the ITT population who (a) met the inclusion/exclusion criteria liable to affect the efficacy assessment and (b) did not violate the protocol in a manner liable to affect the efficacy assessment.'}, {'type': 'SECONDARY', 'title': '10-Minute Math Test - Problems Attempted', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Very Light Breakfast (VLB) Treatment Group', 'description': 'Very Light Breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.'}, {'id': 'OG001', 'title': 'Standard Breakfast (SB) Treatment Group', 'description': 'Standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.'}], 'classes': [{'categories': [{'measurements': [{'value': '116.3', 'spread': '56.14', 'groupId': 'OG000'}, {'value': '118.1', 'spread': '57.74', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Saturday of each of the 2 treatment weeks', 'description': 'The 10-Minute Math Test is a paper and pencil test consisting of several pages of math problems requiring addition, subtraction, multiplication and division calculations presented in ascending order of difficulty during a 10-minute period. Test difficulty was altered for subjects at different skill levels and ages. The number of problems attempted is an objective measure related to "academic productivity". The math test was carried out on the Saturday visit at the end of each of the 2 treatment weeks under supervision of a teacher who had been trained on this test.', 'unitOfMeasure': 'Problems attempted', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat (ITT) population includes all randomized patients with at least one post-baseline measurement of the primary endpoint in both study periods. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.'}, {'type': 'SECONDARY', 'title': '10-Minute Math Test - Problems Solved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Very Light Breakfast (VLB) Treatment Group', 'description': 'Very Light Breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.'}, {'id': 'OG001', 'title': 'Standard Breakfast (SB) Treatment Group', 'description': 'Standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.'}], 'classes': [{'categories': [{'measurements': [{'value': '106.7', 'spread': '58.34', 'groupId': 'OG000'}, {'value': '108.6', 'spread': '60.67', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Saturday of each of the 2 treatment weeks', 'description': 'The 10-Minute Math Test is a paper and pencil test consisting of several pages of math problems requiring addition, subtraction, multiplication and division calculations presented in ascending order of difficulty during a 10-minute period. Test difficulty was altered for subjects at different skill levels and ages. The number of problems attempted is an objective measure related to "academic productivity". The math test was carried out on the Saturday visit at the end of each of the 2 treatment weeks under supervision of a teacher who had been trained on this test.', 'unitOfMeasure': 'Problems solved', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat (ITT) population: All randomized patients with at least one post-baseline measurement of the primary endpoint in both study periods.'}, {'type': 'SECONDARY', 'title': 'Clinical Global Impression Severity (CGI-S) Scale Score - Physician Rating of Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Very Light Breakfast (VLB) Treatment Group', 'description': 'Very Light Breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.'}, {'id': 'OG001', 'title': 'Standard Breakfast (SB) Treatment Group', 'description': 'Standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.75', 'spread': '1.45', 'groupId': 'OG000'}, {'value': '2.74', 'spread': '1.48', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Saturday of each of the 2 treatment weeks', 'description': 'The CGI-S is a scale to assess the global severity of illness. The rating is determined by the investigator answering one question: "Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?" Ratings are on a 7-point scale: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. The rating is based upon the average observed and reported symptoms, behavior, and function in the past 7 days.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat (ITT) population: All randomized patients with at least one post-baseline measurement of the primary endpoint in both study periods.'}, {'type': 'SECONDARY', 'title': 'Clinical Global Impression (CGI-I) Scale Score - Physician Rating of Improvement (Change in State)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Very Light Breakfast (VLB) Treatment Group', 'description': 'Very Light Breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.'}, {'id': 'OG001', 'title': 'Standard Breakfast (SB) Treatment Group', 'description': 'Standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.49', 'spread': '1.08', 'groupId': 'OG000'}, {'value': '3.56', 'spread': '1.18', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Saturday of each of the 2 treatment weeks', 'description': 'The CGI-I is a scale to assess improvement (change in state) of illness. The rating is based on the investigator answering one question: "Compared to the patient\'s condition prior to medication, this patient\'s condition is: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment." The investigator compares the patient\'s overall clinical condition to the 1 week period just prior to the initiation of medication.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat (ITT) population includes all randomized patients with at least one post-baseline measurement of the primary endpoint in both study periods. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Very Light Breakfast (VLB) Then Standard Breakfast (SB)', 'description': 'Very light breakfast (VLB) for one week then crossover to standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.'}, {'id': 'FG001', 'title': 'Standard Breakfast (SB) Then Very Light Breakfast (VLB)', 'description': 'Standard breakfast (SB) for one week then crossover to very light breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '80'}, {'groupId': 'FG001', 'numSubjects': '70'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Information is not available during which cross-over period patients discontinued.', 'groupId': 'FG000', 'numSubjects': '79'}, {'comment': 'Information is not available during which cross-over period patients discontinued.', 'groupId': 'FG001', 'numSubjects': '66'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Very Light Breakfast (VLB) Then Standard Breakfast (SB)', 'description': 'Very light breakfast (VLB) for one week then crossover to standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.'}, {'id': 'BG001', 'title': 'Standard Breakfast (SB) Then Very Light Breakfast (VLB)', 'description': 'Standard breakfast (SB) for one week then crossover to very light breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '9.6', 'spread': '1.6', 'groupId': 'BG000'}, {'value': '9.7', 'spread': '1.5', 'groupId': 'BG001'}, {'value': '9.7', 'spread': '1.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Safety Population', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '112', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Safety Population', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-04', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-04-11', 'studyFirstSubmitDate': '2007-01-29', 'resultsFirstSubmitDate': '2011-01-06', 'studyFirstSubmitQcDate': '2007-01-29', 'lastUpdatePostDateStruct': {'date': '2011-05-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-04-11', 'studyFirstPostDateStruct': {'date': '2007-01-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-05-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Teacher Rating in the Intent-to-Treat (ITT) Population', 'timeFrame': 'Friday of each of the 2 treatment weeks', 'description': 'The FBB-ADHS is a 20-item rating scale. Each item describes a typical ADHD symptom. The 20 items are divided into 3 subscales: Attention deficits (9 items), hyperactivity (7 items), and impulsiveness (4 items). Each item is rated on a scale of 0 = not at all up to 3 = very much. The FBB-ADHS was completed by teachers on Friday afternoon of each week of the study. A total score (sum of all items divided by 20) was calculated. The total score can range from 0 to 3. A lower score indicates more ADHD.'}, {'measure': 'Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Teacher Rating in the Per Protocol (PP) Population', 'timeFrame': 'Friday of each of the 2 treatment weeks', 'description': 'The FBB-ADHS is a 20-item rating scale. Each item describes a typical ADHD symptom. The 20 items are divided into 3 subscales: Attention deficits (9 items), hyperactivity (7 items), and impulsiveness (4 items). Each item is rated on a scale of 0 = not at all up to 3 = very much. The FBB-ADHS was completed by teachers on Friday afternoon of each week of the study. A total score (sum of all items divided by 20) was calculated. The total score can range from 0 to 3. A lower score indicates more ADHD.'}], 'secondaryOutcomes': [{'measure': 'Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Attention Deficit Subscale Teacher Rating', 'timeFrame': 'Friday of each of the 2 treatment weeks', 'description': 'Teacher rating of the attention deficit subscale (9 items), one of 3 subscales in the FBB-ADHS. Each item is rated on a scale of 0 = not at all up to 3 = very much. The rating was completed by teachers on Friday afternoon of each week of the study. A total score (sum of all items divided by 9) was calculated. The total score can range from 0 to 3. A lower score indicates more ADHD.'}, {'measure': 'Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Hyperactivity Subscale Teacher Rating', 'timeFrame': 'Friday of each of the 2 treatment weeks', 'description': 'Teacher rating of the hyperactivity subscale (7 items), one of 3 subscales in the FBB-ADHS. Each item is rated on a scale of 0 = not at all up to 3 = very much. The rating was completed by teachers on Friday afternoon of each week of the study. A total score (sum of all items divided by 7) was calculated. The total score can range from 0 to 3. A lower score indicates more ADHD.'}, {'measure': 'Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Impulsiveness Subscale Teacher Rating', 'timeFrame': 'Friday of each of the 2 treatment weeks', 'description': 'Teacher rating of the hyperactivity subscale (4 items), one of 3 subscales in the FBB-ADHS. Each item is rated on a scale of 0 = not at all up to 3 = very much. The rating was completed by teachers on Friday afternoon of each week of the study. A total score (sum of all items divided by 4) was calculated. The total score can range from 0 to 3. A lower score indicates more ADHD.'}, {'measure': 'Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Parent Rating', 'timeFrame': 'Saturday of each of the 2 treatment weeks', 'description': 'The FBB-ADHS is a 20-item rating scale. Each item describes a typical ADHD symptom. The 20 items are divided into 3 subscales: Attention deficits (9 items), hyperactivity (7 items), and impulsiveness (4 items). Each item is rated on a scale of 0 = not at all up to 3 = very much. The FBB-ADHS was completed by teachers on Friday afternoon of each week of the study. A total score (sum of all items divided by 20) was calculated. The total score can range from 0 to 3. A lower score indicates more ADHD.'}, {'measure': '10-Minute Math Test - Problems Attempted', 'timeFrame': 'Saturday of each of the 2 treatment weeks', 'description': 'The 10-Minute Math Test is a paper and pencil test consisting of several pages of math problems requiring addition, subtraction, multiplication and division calculations presented in ascending order of difficulty during a 10-minute period. Test difficulty was altered for subjects at different skill levels and ages. The number of problems attempted is an objective measure related to "academic productivity". The math test was carried out on the Saturday visit at the end of each of the 2 treatment weeks under supervision of a teacher who had been trained on this test.'}, {'measure': '10-Minute Math Test - Problems Solved', 'timeFrame': 'Saturday of each of the 2 treatment weeks', 'description': 'The 10-Minute Math Test is a paper and pencil test consisting of several pages of math problems requiring addition, subtraction, multiplication and division calculations presented in ascending order of difficulty during a 10-minute period. Test difficulty was altered for subjects at different skill levels and ages. The number of problems attempted is an objective measure related to "academic productivity". The math test was carried out on the Saturday visit at the end of each of the 2 treatment weeks under supervision of a teacher who had been trained on this test.'}, {'measure': 'Clinical Global Impression Severity (CGI-S) Scale Score - Physician Rating of Severity', 'timeFrame': 'Saturday of each of the 2 treatment weeks', 'description': 'The CGI-S is a scale to assess the global severity of illness. The rating is determined by the investigator answering one question: "Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?" Ratings are on a 7-point scale: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. The rating is based upon the average observed and reported symptoms, behavior, and function in the past 7 days.'}, {'measure': 'Clinical Global Impression (CGI-I) Scale Score - Physician Rating of Improvement (Change in State)', 'timeFrame': 'Saturday of each of the 2 treatment weeks', 'description': 'The CGI-I is a scale to assess improvement (change in state) of illness. The rating is based on the investigator answering one question: "Compared to the patient\'s condition prior to medication, this patient\'s condition is: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment." The investigator compares the patient\'s overall clinical condition to the 1 week period just prior to the initiation of medication.'}]}, 'conditionsModule': {'keywords': ['ADHD', 'methylphenidate', 'children', 'food effect', 'Attention-Deficit Hyperactivity Disorder (ADHD) in children'], 'conditions': ['Attention Deficit Hyperactivity Disorder']}, 'descriptionModule': {'briefSummary': 'This study evaluated the safety and clinical effect of treatment with methylphenidate under different breakfast conditions (minimal breakfast versus standard continental breakfast) in children with Attention-Deficit Hyperactivity Disorder (ADHD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged 6-12\n* Diagnosis of Attention-Deficit Hyperactivity Disorder (ADHD)\n* Current medication with either 20 mg or 40 mg immediate release methylphenidate\n\nExclusion Criteria:\n\n* Concomitant psychiatric disorders requiring pharmacological treatment\n* Concomitant severe somatic disorders\n* Eating disorders\n* Addiction disorders\n* Very high or low body weight according to age\n* Known hypersensitivity to methylphenidate\n* Contraindications for methylphenidate\n\nOther protocol-defined inclusion/exclusion criteria applied to the study.'}, 'identificationModule': {'nctId': 'NCT00428792', 'briefTitle': 'Safety and Efficacy of Methylphenidate in Children With Attention-deficit Hyperactivity Disorder (ADHD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'An Open-label, Randomized, Rater-blinded, Cross-over, Multicenter Study Comparing the Clinical Efficacy of Methylphenidate (Immediate Release/Extended Release) Treatment (20 or 40 mg Orally od) in Children With Attention-Deficit Hyperactivity Disorder (ADHD) Under Different Breakfast Conditions Over Two Weeks', 'orgStudyIdInfo': {'id': 'CRIT124DDE04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Very light breakfast (VLB) then standard breakfast (SB)', 'description': 'Very light breakfast (VLB) for one week then crossover to standard breakfast (SB) for one week while taking either 1 or 2 20 mg capsules of methylphenidate once per day based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.', 'interventionNames': ['Drug: Methylphenidate 20 mg long-acting capsules']}, {'type': 'EXPERIMENTAL', 'label': 'Standard breakfast (SB) then very light breakfast (VLB)', 'description': 'Standard breakfast (SB) for one week then crossover to very light breakfast (VLB) for one week while taking either 1 or 2 20 mg capsules of methylphenidate once per day based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.', 'interventionNames': ['Drug: Methylphenidate 20 mg long-acting capsules']}], 'interventions': [{'name': 'Methylphenidate 20 mg long-acting capsules', 'type': 'DRUG', 'otherNames': ['Ritalin LA'], 'armGroupLabels': ['Standard breakfast (SB) then very light breakfast (VLB)', 'Very light breakfast (VLB) then standard breakfast (SB)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Freiburg im Breisgau', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}], 'overallOfficials': [{'name': 'Novartis Pharma', 'role': 'STUDY_CHAIR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'External Affairs', 'oldOrganization': 'Novartis'}}}}