Trial · NCT00585910

Study of Atomoxetine and OROS Methylphenidate to Treat Children and Adolescents Ages 6-17 With ADHD

NCT00585910, Phase 4, Completed, Massachusetts General Hospital; results first posted 2010-05-10

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study of Atomoxetine and OROS Methylphenidate to Treat Children and Adolescents Ages 6-17 With ADHD. Trials, record NCT00585910. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00585910

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study of Atomoxetine and OROS Methylphenidate to Treat Children and Adolescents Ages 6-17 With ADHD
NCT number: NCT00585910
Status: Completed
Phases: Phase 4
Enrollment: 94 participants, actual
Lead sponsor: Massachusetts General Hospital
Conditions: ADHD, Attention Deficit Hyperactivity Disorder
Interventions: Atomoxetine and OROS Methylphenidate
First posted: 2008-01-04
Last updated: 2012-11-14
Results first posted: 2010-05-10
Limitations and caveats: * Open trial so may have been biased;~* Small sample size which may have underestimated findings;~* Used a priori definition of partial response. However, our definition of ATMX partial responders has not been validated.

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Attention Deficit Hyperactivity Disorder Rating Scale (ADHD RS)	7 weeks	The primary outcome was the ADHD rating scale. Change scores for the ADHD Rating Scale (RS), from baseline to endpoint (week 7 or last observation carried forward), were analyzed with paired t-tests and nonparametric Wilcoxon sign-rank tests. The best score is a score of 0 (no ADHD symptoms) and the worst score is the highest score possible (54).
Secondary	Clinical Global Impressions - Level of Severity (CGIs) for ADHD and Other Psychiatric Disorders	7 weeks	Secondary analyses allowed us to evaluate the effects of treatment on additional measures of functioning (CGIs for ADHD and other psychiatric disorders). The CGI-Severity scale is as follows: 0 = Not assessed, 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.

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Attention Deficit Hyperactivity Disorder Rating Scale (ADHD RS)	7 weeks	All analyses were intent to treat, with last observation carried forward.	Units on a Scale	MEAN
SECONDARY	Clinical Global Impressions - Level of Severity (CGIs) for ADHD and Other Psychiatric Disorders	7 weeks		Units on a Scale	MEAN

Source ClinicalTrials.gov

Results by group2

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Attention Deficit Hyperactivity Disorder Rating Scale (ADHD RS)	Overall Study		12.8	Standard Deviation 9.7	Units on a Scale
Clinical Global Impressions - Level of Severity (CGIs) for ADHD and Other Psychiatric Disorders	Overall Study		2.7	Full Range 2.7 to 3.7	Units on a Scale

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Atomoxetine (ATMX) Alone	STARTED	Overall Study	72
Atomoxetine (ATMX) Alone	COMPLETED	Overall Study	55
Atomoxetine (ATMX) Alone	NOT COMPLETED	Overall Study	17
ATMX + Osmotic-Release Methylphenidate	STARTED	Overall Study	50
ATMX + Osmotic-Release Methylphenidate	COMPLETED	Overall Study	41
ATMX + Osmotic-Release Methylphenidate	NOT COMPLETED	Overall Study	9

Source ClinicalTrials.gov

Adverse events14

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
other	Loss of Appetite	Gastrointestinal disorders	ATMX Only	13	67
other	Loss of Appetite	Gastrointestinal disorders	ATMX and OROS MPH	22	50
other	Gastro-Intestinal	Gastrointestinal disorders	ATMX Only	34	67
other	Gastro-Intestinal	Gastrointestinal disorders	ATMX and OROS MPH	17	50
other	Insomnia	General disorders	ATMX Only	10	67
other	Insomnia	General disorders	ATMX and OROS MPH	25	50
other	Headaches	General disorders	ATMX Only	19	67
other	Headaches	General disorders	ATMX and OROS MPH	11	50
other	Irritability	Psychiatric disorders	ATMX Only	11	67
other	Irritability	Psychiatric disorders	ATMX and OROS MPH	16	50

1 to 10 of 14Source ClinicalTrials.gov

See all 14 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	ATMX Only
Total, all-cause mortality	ATMX and OROS MPH
Total, other adverse events	ATMX Only	72	72
Total, other adverse events	ATMX and OROS MPH	50	50
Total, serious adverse events	ATMX Only	0	72
Total, serious adverse events	ATMX and OROS MPH	0	50

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
ATMX Only vs ATMX and OROS MPH: 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT00585910

GET https://conductscience.org/api/trials/v1/NCT00585910/registered

API reference For AI assistants