Trial · NCT02039908

Examining Tolerance to CNS Stimulants in ADHD

NCT02039908, Phase 4, Completed, Florida International University; results first posted 2019-09-17

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Examining Tolerance to CNS Stimulants in ADHD. Trials, record NCT02039908. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02039908

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Trial

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

Title: Examining Tolerance to CNS Stimulants in ADHD
NCT number: NCT02039908
Status: Completed
Phases: Phase 4
Enrollment: 267 participants, actual
Lead sponsor: Florida International University
Conditions: Attention-deficit/Hyperactivity Disorder
Interventions: Methylphenidate
First posted: 2014-01-20
Last updated: 2020-06-09
Results first posted: 2019-09-17

Source ClinicalTrials.gov

Registered outcomes3

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

List	Outcome	Time frame	Description
Primary	Number of Dose Changes Required Per Protocol	10 months	Monthly evaluations of medication efficacy will be used to determine whether dose adjustments are needed due to anticipated tolerance effects.
Secondary	Time to First Dose Increase	10 months	The amount of time elapsed before a child requires a dose increase during the school year will be measured in months.
Secondary	Endpoint Medication Dose	End of Phase 2 School Year	Dose of medication reported in mg/kg/day

Source ClinicalTrials.gov

Outcomes3

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Dose Changes Required Per Protocol	10 months	All participants who began Phase 2 were included in analysis	Number of Increases	MEAN
SECONDARY	Time to First Dose Increase	10 months		Months	MEAN
SECONDARY	Endpoint Medication Dose	End of Phase 2 School Year	Only participants who completed the entire school year are used in endpoint medication dosing calculations.	Mg/kg/day	MEAN

Source ClinicalTrials.gov

Results by group6

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

Outcome	Group	Value	Spread	Units
Number of Dose Changes Required Per Protocol	Methylphenidate 7-day Dosing	1.79	Standard Deviation 1.16	Number of Increases
Number of Dose Changes Required Per Protocol	Methylphenidate 5-day Dosing	1.61	Standard Deviation 1.08	Number of Increases
Time to First Dose Increase	Methylphenidate 7-day Dosing	3.8	Standard Deviation 3.4	Months
Time to First Dose Increase	Methylphenidate 5-day Dosing	4.1	Standard Deviation 3.5	Months
Endpoint Medication Dose	Methylphenidate 7-day Dosing	1.30	Standard Deviation 0.43	Mg/kg/day
Endpoint Medication Dose	Methylphenidate 5-day Dosing	1.24	Standard Deviation 0.41	Mg/kg/day

Source ClinicalTrials.gov

Participant flow24

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

Period	Milestone	Group	Participants
Phase 1-Summer	STARTED	Phase 1-Summer; Medication First, Then Placebo	129
Phase 1-Summer	STARTED	Phase 1-Summer; Placebo First, Then Medication	138
Phase 1-Summer	STARTED	Phase 2 School Year - 7-Day Dosing	0
Phase 1-Summer	STARTED	Phase 2 School Year; 5-Day Dosing	0
Phase 1-Summer	COMPLETED	Phase 1-Summer; Medication First, Then Placebo	116
Phase 1-Summer	COMPLETED	Phase 1-Summer; Placebo First, Then Medication	132
Phase 1-Summer	COMPLETED	Phase 2 School Year - 7-Day Dosing	0
Phase 1-Summer	COMPLETED	Phase 2 School Year; 5-Day Dosing	0
Phase 1-Summer	NOT COMPLETED	Phase 1-Summer; Medication First, Then Placebo	13
Phase 1-Summer	NOT COMPLETED	Phase 1-Summer; Placebo First, Then Medication	6

1 to 10 of 24Source ClinicalTrials.gov

See all 24 participant flow

Adverse events52

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	Appetite Loss	Gastrointestinal disorders	Phase 1-Medication First	66	129	252
other	Appetite Loss	Gastrointestinal disorders	Phase 1 - Placebo First	72	138	265
other	Appetite Loss	Gastrointestinal disorders	Phase 2 - 7-Day Dosing	46	121	131
other	Appetite Loss	Gastrointestinal disorders	Phase 2 - 5-Day Dosing	51	124	143
other	Insomnia	General disorders	Phase 1-Medication First	52	129	163
other	Insomnia	General disorders	Phase 1 - Placebo First	56	138	190
other	Insomnia	General disorders	Phase 2 - 7-Day Dosing	46	121	118
other	Insomnia	General disorders	Phase 2 - 5-Day Dosing	34	124	80
other	Motor Tics	General disorders	Phase 1-Medication First	17	129	23
other	Motor Tics	General disorders	Phase 1 - Placebo First	19	138	25

1 to 10 of 52Source ClinicalTrials.gov

See all 52 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Phase 1-Medication First	0	129
Total, all-cause mortality	Phase 1 - Placebo First	0	138
Total, all-cause mortality	Phase 2 - 7-Day Dosing	0	121
Total, all-cause mortality	Phase 2 - 5-Day Dosing	0	124
Total, other adverse events	Phase 1-Medication First	72	129
Total, other adverse events	Phase 1 - Placebo First	78	138
Total, other adverse events	Phase 2 - 7-Day Dosing	91	121
Total, other adverse events	Phase 2 - 5-Day Dosing	85	124
Total, serious adverse events	Phase 1-Medication First	1	129
Total, serious adverse events	Phase 1 - Placebo First	0	138

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
35604744	DERIVED

Source PubMed

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 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.

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/NCT02039908

GET https://conductscience.org/api/trials/v1/NCT02039908/flow?page=2

API reference For AI assistants