Trial · NCT00183391

Stimulant Versus Nonstimulant Medication for Attention Deficit Hyperactivity Disorder in Children

NCT00183391, Phase 4, Completed, Icahn School of Medicine at Mount Sinai; results first posted 2018-06-06

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Stimulant Versus Nonstimulant Medication for Attention Deficit Hyperactivity Disorder in Children. Trials, record NCT00183391. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00183391

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Trial

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

Title: Stimulant Versus Nonstimulant Medication for Attention Deficit Hyperactivity Disorder in Children
NCT number: NCT00183391
Status: Completed
Phases: Phase 4
Enrollment: 232 participants, actual
Lead sponsor: Icahn School of Medicine at Mount Sinai
Conditions: Attention Deficit Disorder With Hyperactivity
Interventions: Atomoxetine, Methylphenidate
First posted: 2005-09-16
Last updated: 2018-06-06
Results first posted: 2018-06-06

Source ClinicalTrials.gov

Registered outcomes26

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

List	Outcome	Time frame	Description
Primary	ADHD-RS Total Score	up to 14 weeks	ADHD-RS Total Score Attention Deficit Hyperactivity Disorder Rating Scale. Each item on the 18-item measure is scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms), yielding a possible total score of 0-54. Higher score indicates higher probability of diagnosis.
Secondary	Treatment Preference Survey	Measured at ends of treatments one and two
Secondary	ADHD - H/I	up to 14 weeks	Attention deficit/hyperactivity disorder - hyperactivity/impulsivity (ADHD- H/I). Each item on the 18-item measure is scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms), yielding a possible total score of 0-27. Higher score indicates higher probability of diagnosis.
Secondary	ADHD-RS Inattention	up to 14 weeks	Each item on the 18-item measure is scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms), yielding a possible total score of 0-27. Higher score indicates higher probability of diagnosis.
Secondary	Clinical Global Impressions (CGI)- Severity	up to 14 weeks	The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.
Secondary	Social Skills Rating Scale (SSRS)- Parent Version	up to 14 weeks	Measure of social skills, higher score is better. This scale is based on t-scores and does not have psychometrics available.
Secondary	Child Conflict Index (CCI)	up to 14 weeks	Measure of conflict within the home over the past 24 hours. The CCI is a validated measure of family conflicts in the home and is completed by parents. It consists of 42 items (for boys) or 36 items (for girls) reflecting attention-seeking and conflictual behavior, as well as negativity and withdrawal. Items are scored as yes (1 point) or no (0 points). Mean score between 0 and 1 reported, with higher score indicating greater conflict.
Secondary	Continuous Performance Test (CPT)	up to 14 weeks	CPT Commissions, impulsive responses, higher score is worse. This scale is based on t-scores and does not have psychometrics available.
Secondary	Children's Sleep Questionnaire	up to 14 weeks	Children's Sleep Problems Severity, sum of scores, higher is worse.The scale assessed contains 16 items, each scored 0 to 3, with 0 representing no problems and 3 representing daily problems. total range from 0 to 48. This score does not have psychometrics available.
Secondary	Assessment of Affective Range (AAR)	up to 14 weeks	Affective problems. This scale consists of 8 items, scored 0-3, with 0 representing no problems and 3 representing extreme problems. This analysis presents sum of scores, higher is worse. Full range from 0 to 24. This score does not have psychometrics available.

1 to 10 of 26Source ClinicalTrials.gov

See all 26 registered outcomes

Outcomes26

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	ADHD-RS Total Score	up to 14 weeks	see participant flow section for participants that did not complete blocks	units on a scale	MEAN
SECONDARY	Treatment Preference Survey	Measured at ends of treatments one and two		percentage of participants	NUMBER
SECONDARY	ADHD - H/I	up to 14 weeks	see participant flow section for participants that did not complete blocks	units on a scale	MEAN
SECONDARY	ADHD-RS Inattention	up to 14 weeks	see participant flow section for participants that did not complete blocks	units on a scale	MEAN
SECONDARY	Clinical Global Impressions (CGI)- Severity	up to 14 weeks	see participant flow section for participants that did not complete blocks	units on a scale	MEAN
SECONDARY	Social Skills Rating Scale (SSRS)- Parent Version	up to 14 weeks	see participant flow section for participants that did not complete blocks	t-score	MEAN
SECONDARY	Child Conflict Index (CCI)	up to 14 weeks	see participant flow section for participants that did not complete blocks	units on a scale	MEAN
SECONDARY	Continuous Performance Test (CPT)	up to 14 weeks	see participant flow section for participants that did not complete blocks	T-scores	MEAN
SECONDARY	Children's Sleep Questionnaire	up to 14 weeks	see participant flow section for participants that did not complete blocks	units on a scale	MEAN
SECONDARY	Assessment of Affective Range (AAR)	up to 14 weeks	see participant flow section for participants that did not complete blocks	units on a scale	MEAN

1 to 10 of 26Source ClinicalTrials.gov

See all 26 outcomes

Results by group124

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

Outcome	Group	Category	Value	Spread	Units
ADHD-RS Total Score	Atomoxetine Then Methylphenidate	Block 1 Baseline Week 0	39.58	Standard Deviation 8.984	units on a scale
ADHD-RS Total Score	Methylphenidate Then Atomoxetine	Block 1 Baseline Week 0	39.75	Standard Deviation 9.835	units on a scale
ADHD-RS Total Score	Atomoxetine Then Methylphenidate	Block 1 End of Treatment Week 6	20.03	Standard Deviation 13.657	units on a scale
ADHD-RS Total Score	Methylphenidate Then Atomoxetine	Block 1 End of Treatment Week 6	17.59	Standard Deviation 12.756	units on a scale
ADHD-RS Total Score	Atomoxetine Then Methylphenidate	Block 2 Baseline Week 8	34.32	Standard Deviation 11.423	units on a scale
ADHD-RS Total Score	Methylphenidate Then Atomoxetine	Block 2 Baseline Week 8	33.54	Standard Deviation 12.077	units on a scale
ADHD-RS Total Score	Atomoxetine Then Methylphenidate	Blocks 2 End of Treatment Week 14	18.08	Standard Deviation 12.192	units on a scale
ADHD-RS Total Score	Methylphenidate Then Atomoxetine	Blocks 2 End of Treatment Week 14	22.13	Standard Deviation 13.356	units on a scale
Treatment Preference Survey	Atomoxetine Then Methylphenidate	Treatment Preference of ATX	41.8		percentage of participants
Treatment Preference Survey	Methylphenidate Then Atomoxetine	Treatment Preference of ATX	27.4		percentage of participants

1 to 10 of 124Source ClinicalTrials.gov

See all 124 results by group

Participant flow18

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

Period	Milestone	Group	Participants
Block 1 - 5 Weeks	STARTED	Atomoxetine Then Methylphenidate	108
Block 1 - 5 Weeks	STARTED	Methylphenidate Then Atomoxetine	124
Block 1 - 5 Weeks	COMPLETED	Atomoxetine Then Methylphenidate	95
Block 1 - 5 Weeks	COMPLETED	Methylphenidate Then Atomoxetine	110
Block 1 - 5 Weeks	NOT COMPLETED	Atomoxetine Then Methylphenidate	13
Block 1 - 5 Weeks	NOT COMPLETED	Methylphenidate Then Atomoxetine	14
Crossover Placebo - 2 Weeks	STARTED	Atomoxetine Then Methylphenidate	95
Crossover Placebo - 2 Weeks	STARTED	Methylphenidate Then Atomoxetine	110
Crossover Placebo - 2 Weeks	COMPLETED	Atomoxetine Then Methylphenidate	95
Crossover Placebo - 2 Weeks	COMPLETED	Methylphenidate Then Atomoxetine	110

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events16

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	Insomnia	General disorders	Block 1 ATX	5	108
other	Insomnia	General disorders	Block 1 MPH	16	124
other	Insomnia	General disorders	Block 2 ATX	3	95
other	Insomnia	General disorders	Block 2 MPH	14	110
other	Aggression	Psychiatric disorders	Block 1 ATX	6	108
other	Aggression	Psychiatric disorders	Block 1 MPH	6	124
other	Aggression	Psychiatric disorders	Block 2 ATX	5	95
other	Aggression	Psychiatric disorders	Block 2 MPH	4	110
other	Appetite Loss	Gastrointestinal disorders	Block 1 ATX	7	108
other	Appetite Loss	Gastrointestinal disorders	Block 1 MPH	9	124

1 to 10 of 16Source ClinicalTrials.gov

See all 16 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Block 1 ATX	0	108
Total, all-cause mortality	Block 1 MPH	0	124
Total, all-cause mortality	Block 2 ATX	0	95
Total, all-cause mortality	Block 2 MPH	0	110
Total, other adverse events	Block 1 ATX	24	108
Total, other adverse events	Block 1 MPH	35	124
Total, other adverse events	Block 2 ATX	20	95
Total, other adverse events	Block 2 MPH	25	110
Total, serious adverse events	Block 1 ATX	0	108
Total, serious adverse events	Block 1 MPH	0	124

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
24942409	RESULT	PubMed
28647012	DERIVED	PubMed

Grants2

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	Source
R01MH070564	Measuring and Predicting Responses to ATX and MPH	STEIN, MARK A	UNIVERSITY OF ILLINOIS AT CHICAGO	NATIONAL INSTITUTE OF MENTAL HEALTH	2005 to 2009	NIH RePORTER
R01MH070935	Predicting Response to Atomoxetine and Methlyphenidate	NEWCORN, JEFFREY H	ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI	NATIONAL INSTITUTE OF MENTAL HEALTH	2005 to 2009	NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests1

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as
Continuous Performance Test	Secondary outcome

Source ConductCognition

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/NCT00183391

GET https://conductscience.org/api/trials/v1/NCT00183391/registered?page=2

API reference For AI assistants