Examining Tolerance to CNS Stimulants in ADHD
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ClinicalTrials.gov Identifier: NCT02039908 |
Recruitment Status :
Completed
First Posted : January 20, 2014
Results First Posted : September 17, 2019
Last Update Posted : June 9, 2020
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Sponsor:
Florida International University
Information provided by (Responsible Party):
Florida International University
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Condition |
Attention-deficit/Hyperactivity Disorder |
Intervention |
Drug: Methylphenidate |
Enrollment | 267 |
Participant Flow
Recruitment Details | Participants were recruited in 4 annual cohorts from 2013-2016. Participants could be referred by schools, physicians, or community advertisement; interested parents completed phone screens and a clinic intake to assess inclusionary and exclusionary criteria. |
Pre-assignment Details | Because all participants were required to be enrolled in a Summer Treatment Program, some participants withdrew after consenting because they were unable to make the time commitment to the 8-week summer program. |
Arm/Group Title | Phase 1-Summer; Medication First, Then Placebo | Phase 1-Summer; Placebo First, Then Medication | Phase 2 School Year - 7-Day Dosing | Phase 2 School Year; 5-Day Dosing |
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In the first phase of the study, children participated in a crossover design of placebo and optimal-dose methylphenidate for 13 days in each condition. After a 9-day titration period, the Medication First group received their optimal dose of methylphenidate for 13 days, a 2-day medication/placebo probe, a 2-day washout, then placebo for 13 days and a 2-day medication/placebo probe. | In the first phase of the study, children participated in a crossover design of placebo and optimal-dose methylphenidate for 13 days in each condition. After a 9-day titration period, the Placebo First group received placebo for 13 days, a 2-day medication/placebo probe, a 2-day washout, then optimal-dose medication for 13 days and a 2-day medication/placebo probe. | During the school year, all participants took their optimal dose determined in Phase 1 of the study for the entire school year. These partcipants received medication 7-days a week for the entire year. | During the school year, all participants took their optimal dose determined during Phase 1 for the entire school year. These participants received medication on school-days only with drug holidays over weekends. |
Period Title: Phase 1-Summer | ||||
Started | 129 | 138 | 0 | 0 |
Completed | 116 | 132 | 0 | 0 |
Not Completed | 13 | 6 | 0 | 0 |
Reason Not Completed | ||||
Withdrawal by Subject | 7 | 6 | 0 | 0 |
Protocol Violation | 6 | 0 | 0 | 0 |
Period Title: Phase 2-School Year | ||||
Started [1] | 0 | 0 | 121 | 124 |
Completed | 0 | 0 | 109 | 116 |
Not Completed | 0 | 0 | 12 | 8 |
Reason Not Completed | ||||
Lost to Follow-up | 0 | 0 | 1 | 3 |
Protocol Violation | 0 | 0 | 3 | 0 |
Withdrawal by Subject | 0 | 0 | 8 | 5 |
[1]
Three participants elected not to continue in the study for the school -year phase.
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Baseline Characteristics
Arm/Group Title | Phase 1-Summer | |
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In the first phase of the study, all children participate in a crossover design of placebo and optimal-dose methylphenidate for 13 days in each condition. | |
Overall Number of Baseline Participants | 267 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 267 participants | |
<=18 years |
267 100.0%
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Between 18 and 65 years |
0 0.0%
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>=65 years |
0 0.0%
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 267 participants | |
Female |
54 20.2%
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Male |
213 79.8%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 267 participants | |
Hispanic or Latino |
224 83.9%
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Not Hispanic or Latino |
43 16.1%
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Unknown or Not Reported |
0 0.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 267 participants | |
American Indian or Alaska Native |
0 0.0%
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Asian |
2 0.7%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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Black or African American |
22 8.2%
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White |
237 88.8%
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More than one race |
6 2.2%
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Unknown or Not Reported |
0 0.0%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 267 participants |
267 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | William E. Pelham, Jr., Ph.D. |
Organization: | Florida International University |
Phone: | 305-348-0477 |
EMail: | wpelham@fiu.edu |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Florida International University |
ClinicalTrials.gov Identifier: | NCT02039908 |
Other Study ID Numbers: |
MH099030 |
First Submitted: | March 7, 2013 |
First Posted: | January 20, 2014 |
Results First Submitted: | July 29, 2019 |
Results First Posted: | September 17, 2019 |
Last Update Posted: | June 9, 2020 |