Trial · NCT00429273
Single Versus Combination Medication Treatment for Children With Attention Deficit Hyperactivity Disorder
NCT00429273, Phase 4, Completed, University of California, Los Angeles; results first posted 2017-06-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Single Versus Combination Medication Treatment for Children With Attention Deficit Hyperactivity Disorder. Trials, record NCT00429273. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00429273
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Single Versus Combination Medication Treatment for Children With Attention Deficit Hyperactivity Disorder
- NCT number
- NCT00429273
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 212 participants, actual
- Lead sponsor
- University of California, Los Angeles
- Conditions
- Attention Deficit Disorder With Hyperactivity
- Interventions
- Guanfacine, Methylphenidate (MPH)
- First posted
- 2007-01-31
- Last updated
- 2021-07-30
- Results first posted
- 2017-06-14
- Limitations and caveats
Larger group sizes would enable more conclusive tests of treatment differences; Study design began with guanfacine first and addition of a stimulant second, making difficult to compare to those study designs adding guanfacine to ongoing stimulants.
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | ADHD IV Rating Scale (Attention Deficit Hyperactivity Disorder Rating Scale) | Measured at baseline Week 4 and Week 8 | The primary clinical efficacy variable for treatment was the ADHD-RS-IV (Attention-Deficit/Hyperactivity Disorder Rating Scale) Total Score and two sub-scales (Inattentive and Hyperactive-Impulsive ). The rating scale has 18 questions with answer options: None (0), Mild (1), Moderate (2) and Severe (3). Min 0; max 3. Scores are obtained by summing each item; The higher the score, the worse the outcome. Total score range: 0-54 Total Inattentive score range: 0-27 Total Hyperactive/Impulsive score range: 0-27 |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | ADHD IV Rating Scale (Attention Deficit Hyperactivity Disorder Rating Scale) | Measured at baseline Week 4 and Week 8 | Every contrast includes estimates of maturation/time trend and the within subject covariance structure based on all participants using full information maximum likelihood estimation. | units on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| ADHD IV Rating Scale (Attention Deficit Hyperactivity Disorder Rating Scale) | Estimated Difference Between Guan and Placebo | Total ADHD-RS Score | -7.77 | Standard Error 1.70 | units on a scale |
| ADHD IV Rating Scale (Attention Deficit Hyperactivity Disorder Rating Scale) | Estimated Difference Between DMPH and Placebo | Total ADHD-RS Score | -7.99 | Standard Error 1.22 | units on a scale |
| ADHD IV Rating Scale (Attention Deficit Hyperactivity Disorder Rating Scale) | Estimated Difference Between Placebo and Combo | Total ADHD-RS Score | -10.66 | Standard Error 1.99 | units on a scale |
| ADHD IV Rating Scale (Attention Deficit Hyperactivity Disorder Rating Scale) | Estimated Difference Between Guan and Placebo | Inattentive Subscale | -4.14 | Standard Error 0.99 | units on a scale |
| ADHD IV Rating Scale (Attention Deficit Hyperactivity Disorder Rating Scale) | Estimated Difference Between DMPH and Placebo | Inattentive Subscale | -4.10 | Standard Error 0.71 | units on a scale |
| ADHD IV Rating Scale (Attention Deficit Hyperactivity Disorder Rating Scale) | Estimated Difference Between Placebo and Combo | Inattentive Subscale | -5.89 | Standard Error 1.15 | units on a scale |
| ADHD IV Rating Scale (Attention Deficit Hyperactivity Disorder Rating Scale) | Estimated Difference Between Guan and Placebo | Hyperactive Impulsive Subscale | -3.73 | Standard Error 0.92 | units on a scale |
| ADHD IV Rating Scale (Attention Deficit Hyperactivity Disorder Rating Scale) | Estimated Difference Between DMPH and Placebo | Hyperactive Impulsive Subscale | -4.0 | Standard Error 0.69 | units on a scale |
| ADHD IV Rating Scale (Attention Deficit Hyperactivity Disorder Rating Scale) | Estimated Difference Between Placebo and Combo | Hyperactive Impulsive Subscale | -5.10 | Standard Error 1.12 | units on a scale |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group 1: Guan-Guan+Placebo | 68 | |
| Overall Study | STARTED | Group 2: Placebo-Placebo+DMPH | 69 | |
| Overall Study | STARTED | Group 3: Guan-Guan+DMPH | 70 | |
| Overall Study | COMPLETED | Group 1: Guan-Guan+Placebo | 60 | |
| Overall Study | COMPLETED | Group 2: Placebo-Placebo+DMPH | 61 | |
| Overall Study | COMPLETED | Group 3: Guan-Guan+DMPH | 61 | |
| Overall Study | NOT COMPLETED | Group 1: Guan-Guan+Placebo | 8 | |
| Overall Study | NOT COMPLETED | Group 2: Placebo-Placebo+DMPH | 8 | |
| Overall Study | NOT COMPLETED | Group 3: Guan-Guan+DMPH | 9 |
Source ClinicalTrials.gov
Adverse events36
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal Pain Upper | Gastrointestinal disorders | Group 1: Guan-Guan+Placebo | 11 | 68 | 11 |
| other | Abdominal Pain Upper | Gastrointestinal disorders | Group 2: Placebo-Placebo+DMPH | 10 | 69 | 10 |
| other | Abdominal Pain Upper | Gastrointestinal disorders | Group 3: Guan-Guan+DMPH | 10 | 70 | 10 |
| other | Abdominal Pain | Gastrointestinal disorders | Group 1: Guan-Guan+Placebo | 19 | 68 | 19 |
| other | Abdominal Pain | Gastrointestinal disorders | Group 2: Placebo-Placebo+DMPH | 18 | 69 | 18 |
| other | Abdominal Pain | Gastrointestinal disorders | Group 3: Guan-Guan+DMPH | 16 | 70 | 16 |
| other | Headache | Psychiatric disorders | Group 1: Guan-Guan+Placebo | 34 | 68 | 34 |
| other | Headache | Psychiatric disorders | Group 2: Placebo-Placebo+DMPH | 23 | 69 | 23 |
| other | Headache | Psychiatric disorders | Group 3: Guan-Guan+DMPH | 23 | 70 | 23 |
| other | Irritability | Psychiatric disorders | Group 1: Guan-Guan+Placebo | 15 | 68 | 15 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group 1: Guan-Guan+Placebo | 0 | 68 |
| Total, all-cause mortality | Group 2: Placebo-Placebo+DMPH | 0 | 69 |
| Total, all-cause mortality | Group 3: Guan-Guan+DMPH | 0 | 70 |
| Total, other adverse events | Group 1: Guan-Guan+Placebo | 66 | 68 |
| Total, other adverse events | Group 2: Placebo-Placebo+DMPH | 66 | 69 |
| Total, other adverse events | Group 3: Guan-Guan+DMPH | 69 | 70 |
| Total, serious adverse events | Group 1: Guan-Guan+Placebo | 0 | 68 |
| Total, serious adverse events | Group 2: Placebo-Placebo+DMPH | 0 | 69 |
| Total, serious adverse events | Group 3: Guan-Guan+DMPH | 0 | 70 |
Source ClinicalTrials.gov
Papers8
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P50MH077248 | CIDAR: Translational Research to Enhance Cognitive Control (TRECC) | MCCRACKEN, JAMES T. | UNIVERSITY OF CALIFORNIA LOS ANGELES | NATIONAL INSTITUTE OF MENTAL HEALTH | 2006 to 2011 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00429273
GET https://conductscience.org/api/trials/v1/NCT00429273/events?page=2