Skip to main content
OpenTrials
Completed

NCT Number: NCT00428792

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative Site

Freiburg im Breisgau, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Methylphenidate 20 mg long-acting capsules

Drug

Other names: Ritalin LA

Primary outcomes

  1. 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

    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.

  2. Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Teacher Rating in the Per Protocol (PP) Population

    Time frame: Friday of each of the 2 treatment weeks

    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.

Secondary outcomes

  1. Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Attention Deficit Subscale Teacher Rating

    Time frame: Friday of each of the 2 treatment weeks

    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.

  2. Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Hyperactivity Subscale Teacher Rating

    Time frame: Friday of each of the 2 treatment weeks

    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.

  3. Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Impulsiveness Subscale Teacher Rating

    Time frame: Friday of each of the 2 treatment weeks

    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.

  4. Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Parent Rating

    Time frame: Saturday of each of the 2 treatment weeks

    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.

  5. 10-Minute Math Test - Problems Attempted

    Time frame: Saturday of each of the 2 treatment weeks

    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.

  6. 10-Minute Math Test - Problems Solved

    Time frame: Saturday of each of the 2 treatment weeks

    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.

  7. Clinical Global Impression Severity (CGI-S) Scale Score - Physician Rating of Severity

    Time frame: Saturday of each of the 2 treatment weeks

    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.

  8. Clinical Global Impression (CGI-I) Scale Score - Physician Rating of Improvement (Change in State)

    Time frame: Saturday of each of the 2 treatment weeks

    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.

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Jan 30, 2007
Registry last updated
May 6, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.