NCT00428792

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2007

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 30, 2007

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2007

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

May 6, 2011

Completed
Last Updated

May 6, 2011

Status Verified

April 1, 2011

Enrollment Period

8 months

First QC Date

January 29, 2007

Results QC Date

January 6, 2011

Last Update Submit

April 11, 2011

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

ADHDmethylphenidatechildrenfood effectAttention-Deficit Hyperactivity Disorder (ADHD) in children

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (8)

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

    Friday of each of the 2 treatment weeks

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

    Friday of each of the 2 treatment weeks

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

    Friday of each of the 2 treatment weeks

  • Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Parent Rating

    Saturday of each of the 2 treatment weeks

  • 10-Minute Math Test - Problems Attempted

    Saturday of each of the 2 treatment weeks

  • +3 more secondary outcomes

Study Arms (2)

Very light breakfast (VLB) then standard breakfast (SB)

EXPERIMENTAL

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

Standard breakfast (SB) then very light breakfast (VLB)

EXPERIMENTAL

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

Interventions

Methylphenidate 20 mg long-acting capsulesDRUG
Also known as: Ritalin LA
Standard breakfast (SB) then very light breakfast (VLB)Very light breakfast (VLB) then standard breakfast (SB)

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Investigative Site

Freiburg im Breisgau, Germany

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Study Director
Organization
Novartis Pharmaceuticals
862 778-8300

Study Officials

  • Novartis Pharma

    Novartis Pharmaceuticals

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 29, 2007

First Posted

January 30, 2007

Study Start

April 1, 2007

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

May 6, 2011

Results First Posted

May 6, 2011

Record last verified: 2011-04

Locations

DE(1)