Safety and Efficacy of Methylphenidate in Children With Attention-deficit Hyperactivity Disorder (ADHD)

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00428792
First received: January 29, 2007
Last updated: April 11, 2011
Last verified: April 2011

January 29, 2007
April 11, 2011
April 2007
December 2007   (final data collection date for primary outcome measure)
  • Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Teacher Rating in the Intent-to-Treat (ITT) Population [ Time Frame: Friday of each of the 2 treatment weeks ] [ Designated as safety issue: No ]
    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.
  • Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Teacher Rating in the Per Protocol (PP) Population [ Time Frame: Friday of each of the 2 treatment weeks ] [ Designated as safety issue: No ]
    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.
Validated questionnaire about core ADHD symptoms (Fremdbeobachtungsskala-Aufmerksamkeitsdefizit-Hyperaktivitätssyndrom, FBB-AHDS) filled out by a teacher after one week and two weeks
Complete list of historical versions of study NCT00428792 on ClinicalTrials.gov Archive Site
  • Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Attention Deficit Subscale Teacher Rating [ Time Frame: Friday of each of the 2 treatment weeks ] [ Designated as safety issue: No ]
    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.
  • Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Hyperactivity Subscale Teacher Rating [ Time Frame: Friday of each of the 2 treatment weeks ] [ Designated as safety issue: No ]
    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.
  • Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Impulsiveness Subscale Teacher Rating [ Time Frame: Friday of each of the 2 treatment weeks ] [ Designated as safety issue: No ]
    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.
  • Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Parent Rating [ Time Frame: Saturday of each of the 2 treatment weeks ] [ Designated as safety issue: No ]
    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.
  • 10-Minute Math Test - Problems Attempted [ Time Frame: Saturday of each of the 2 treatment weeks ] [ Designated as safety issue: No ]
    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.
  • 10-Minute Math Test - Problems Solved [ Time Frame: Saturday of each of the 2 treatment weeks ] [ Designated as safety issue: No ]
    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.
  • Clinical Global Impression Severity (CGI-S) Scale Score - Physician Rating of Severity [ Time Frame: Saturday of each of the 2 treatment weeks ] [ Designated as safety issue: No ]
    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.
  • Clinical Global Impression (CGI-I) Scale Score - Physician Rating of Improvement (Change in State) [ Time Frame: Saturday of each of the 2 treatment weeks ] [ Designated as safety issue: No ]
    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.
  • Validated questionnaire about core ADHD symptoms filled out by parents after one week and two weeks
  • Clinical global impression rated by treating physician after one week, two weeks and at closeout
  • Math test (number of maths problems attempted and number of correctly solved math problems) at baseline, after one and two weeks
Not Provided
Not Provided
 
Safety and Efficacy of Methylphenidate in Children With Attention-deficit Hyperactivity Disorder (ADHD)
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

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).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Attention Deficit Hyperactivity Disorder
Drug: Methylphenidate 20 mg long-acting capsules
Other Name: Ritalin LA
  • Experimental: Very light breakfast (VLB) then standard breakfast (SB)
    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.
    Intervention: Drug: Methylphenidate 20 mg long-acting capsules
  • Experimental: Standard breakfast (SB) then very light breakfast (VLB)
    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.
    Intervention: Drug: Methylphenidate 20 mg long-acting capsules
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
December 2007
December 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Children aged 6-12
  • Diagnosis of Attention-Deficit Hyperactivity Disorder (ADHD)
  • Current medication with either 20 mg or 40 mg immediate release methylphenidate

Exclusion Criteria:

  • Concomitant psychiatric disorders requiring pharmacological treatment
  • Concomitant severe somatic disorders
  • Eating disorders
  • Addiction disorders
  • Very high or low body weight according to age
  • Known hypersensitivity to methylphenidate
  • Contraindications for methylphenidate

Other protocol-defined inclusion/exclusion criteria applied to the study.

Both
6 Years to 12 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00428792
CRIT124DDE04
Not Provided
External Affairs, Novartis
Novartis
Not Provided
Study Chair: Novartis Pharma Novartis Pharmaceuticals
Novartis
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP