Trial · NCT00428792
Safety and Efficacy of Methylphenidate in Children With Attention-deficit Hyperactivity Disorder (ADHD)
NCT00428792, Phase 3, Completed, Novartis; results first posted 2011-05-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy of Methylphenidate in Children With Attention-deficit Hyperactivity Disorder (ADHD). Trials, record NCT00428792. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00428792
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Methylphenidate in Children With Attention-deficit Hyperactivity Disorder (ADHD)
- NCT number
- NCT00428792
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 150 participants, actual
- Lead sponsor
- Novartis
- Conditions
- Attention Deficit Hyperactivity Disorder
- Interventions
- Methylphenidate 20 mg long-acting capsules
- First posted
- 2007-01-30
- Last updated
- 2011-05-06
- Results first posted
- 2011-05-06
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Teacher Rating in the Intent-to-Treat (ITT) Population | 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. |
| Primary | Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Teacher Rating in the Per Protocol (PP) Population | 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 | Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Attention Deficit Subscale Teacher Rating | 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. |
| Secondary | Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Hyperactivity Subscale Teacher Rating | 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. |
| Secondary | Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Impulsiveness Subscale Teacher Rating | 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. |
| Secondary | Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Parent Rating | 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. |
| Secondary | 10-Minute Math Test - Problems Attempted | 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. |
| Secondary | 10-Minute Math Test - Problems Solved | 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. |
| Secondary | Clinical Global Impression Severity (CGI-S) Scale Score - Physician Rating of Severity | 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. |
| Secondary | Clinical Global Impression (CGI-I) Scale Score - Physician Rating of Improvement (Change in State) | 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. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Teacher Rating in the Intent-to-Treat (ITT) Population | Friday of each of the 2 treatment weeks | Intent to treat (ITT) population: All randomized patients with at least one post-baseline measurement of the primary endpoint in both study periods. | Units on a scale | MEAN |
| SECONDARY | Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Attention Deficit Subscale Teacher Rating | Friday of each of the 2 treatment weeks | Intent to treat (ITT) population: All randomized patients with at least one post-baseline measurement of the primary endpoint in both study periods. | Units on a scale | MEAN |
| SECONDARY | Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Hyperactivity Subscale Teacher Rating | Friday of each of the 2 treatment weeks | Intent to treat (ITT) population: All randomized patients with at least one post-baseline measurement of the primary endpoint in both study periods. | Units on a scale | MEAN |
| SECONDARY | Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Impulsiveness Subscale Teacher Rating | Friday of each of the 2 treatment weeks | Intent to treat (ITT) population: All randomized patients with at least one post-baseline measurement of the primary endpoint in both study periods. | Units on a scale | MEAN |
| SECONDARY | Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Parent Rating | Saturday of each of the 2 treatment weeks | Intent to treat (ITT) population: All randomized patients with at least one post-baseline measurement of the primary endpoint in both study periods. | Units on a scale | MEAN |
| PRIMARY | Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Teacher Rating in the Per Protocol (PP) Population | Friday of each of the 2 treatment weeks | 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. | Units on a scale | MEAN |
| SECONDARY | 10-Minute Math Test - Problems Attempted | Saturday of each of the 2 treatment weeks | 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. | Problems attempted | MEAN |
| SECONDARY | 10-Minute Math Test - Problems Solved | Saturday of each of the 2 treatment weeks | Intent to treat (ITT) population: All randomized patients with at least one post-baseline measurement of the primary endpoint in both study periods. | Problems solved | MEAN |
| SECONDARY | Clinical Global Impression Severity (CGI-S) Scale Score - Physician Rating of Severity | Saturday of each of the 2 treatment weeks | Intent to treat (ITT) population: All randomized patients with at least one post-baseline measurement of the primary endpoint in both study periods. | Units on a scale | MEAN |
| SECONDARY | Clinical Global Impression (CGI-I) Scale Score - Physician Rating of Improvement (Change in State) | Saturday of each of the 2 treatment weeks | 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. | Units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Teacher Rating in the Intent-to-Treat (ITT) Population | Very Light Breakfast (VLB) Treatment Group | 0.97 | Standard Deviation 0.63 | Units on a scale | |
| Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Teacher Rating in the Intent-to-Treat (ITT) Population | Standard Breakfast (SB) Treatment Group | 1.01 | Standard Deviation 0.63 | Units on a scale | |
| Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Attention Deficit Subscale Teacher Rating | Very Light Breakfast (VLB) Treatment Group | 1.19 | Standard Deviation 0.68 | Units on a scale | |
| Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Attention Deficit Subscale Teacher Rating | Standard Breakfast (SB) Treatment Group | 1.23 | Standard Deviation 0.69 | Units on a scale | |
| Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Hyperactivity Subscale Teacher Rating | Very Light Breakfast (VLB) Treatment Group | 0.72 | Standard Deviation 0.70 | Units on a scale | |
| Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Hyperactivity Subscale Teacher Rating | Standard Breakfast (SB) Treatment Group | 0.75 | Standard Deviation 0.69 | Units on a scale | |
| Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Impulsiveness Subscale Teacher Rating | Very Light Breakfast (VLB) Treatment Group | 0.93 | Standard Deviation 0.92 | Units on a scale | |
| Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Impulsiveness Subscale Teacher Rating | Standard Breakfast (SB) Treatment Group | 0.99 | Standard Deviation 0.90 | Units on a scale | |
| Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Parent Rating | Very Light Breakfast (VLB) Treatment Group | 1.15 | Standard Deviation 0.60 | Units on a scale | |
| Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Parent Rating | Standard Breakfast (SB) Treatment Group | 1.11 | Standard Deviation 0.55 | Units on a scale |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Very Light Breakfast (VLB) Then Standard Breakfast (SB) | 80 | |
| Overall Study | STARTED | Standard Breakfast (SB) Then Very Light Breakfast (VLB) | 70 | |
| Overall Study | COMPLETED | Very Light Breakfast (VLB) Then Standard Breakfast (SB) | 79 | |
| Overall Study | COMPLETED | Standard Breakfast (SB) Then Very Light Breakfast (VLB) | 66 | |
| Overall Study | NOT COMPLETED | Very Light Breakfast (VLB) Then Standard Breakfast (SB) | 1 | |
| Overall Study | NOT COMPLETED | Standard Breakfast (SB) Then Very Light Breakfast (VLB) | 4 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Very Light Breakfast (VLB) Then Standard Breakfast (SB) | ||
| Total, all-cause mortality | Standard Breakfast (SB) Then Very Light Breakfast (VLB) | ||
| Total, other adverse events | Very Light Breakfast (VLB) Then Standard Breakfast (SB) | 0 | 148 |
| Total, other adverse events | Standard Breakfast (SB) Then Very Light Breakfast (VLB) | 0 | 149 |
| Total, serious adverse events | Very Light Breakfast (VLB) Then Standard Breakfast (SB) | 0 | 148 |
| Total, serious adverse events | Standard Breakfast (SB) Then Very Light Breakfast (VLB) | 0 | 149 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Very Light Breakfast (VLB) Then Standard Breakfast (SB) vs Standard Breakfast (SB) Then Very Light Breakfast (VLB): serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00428792
GET https://conductscience.org/api/trials/v1/NCT00428792/registered