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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Attention Deficit Hyperactivity Disorder

Intervention / Treatment
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* Drug: Methylphenidate 20 mg long-acting capsules


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Very light breakfast (VLB) then standard breakfast (SB)<br>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. | Drug: Methylphenidate 20 mg long-acting capsules<br> <br> * Other names: Ritalin LA;|
| Experimental: Standard breakfast (SB) then very light breakfast (VLB)<br>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. | Drug: Methylphenidate 20 mg long-acting capsules<br> <br> * Other names: Ritalin LA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Teacher Rating in the Intent-to-Treat (ITT) Population | 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. | Friday of each of the 2 treatment weeks | 
| Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Teacher Rating in the Per Protocol (PP) Population | 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. | Friday of each of the 2 treatment weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Attention Deficit Subscale Teacher Rating | 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. | Friday of each of the 2 treatment weeks | 
| Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Hyperactivity Subscale Teacher Rating | 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. | Friday of each of the 2 treatment weeks | 
| Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Impulsiveness Subscale Teacher Rating | 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. | Friday of each of the 2 treatment weeks | 
| Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Parent Rating | 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. | Saturday of each of the 2 treatment weeks | 
| 10-Minute Math Test - Problems Attempted | 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. | Saturday of each of the 2 treatment weeks | 
| 10-Minute Math Test - Problems Solved | 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. | Saturday of each of the 2 treatment weeks | 
| Clinical Global Impression Severity (CGI-S) Scale Score - Physician Rating of Severity | 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. | Saturday of each of the 2 treatment weeks | 
| Clinical Global Impression (CGI-I) Scale Score - Physician Rating of Improvement (Change in State) | 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. | Saturday of each of the 2 treatment weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADHD, methylphenidate, children, food effect, Attention-Deficit Hyperactivity Disorder (ADHD) in children