Single Versus Combination Medication Treatment for Children With Attention Deficit Hyperactivity Disorder (Project1)
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ClinicalTrials.gov Identifier: NCT00429273 |
Recruitment Status :
Completed
First Posted : January 31, 2007
Results First Posted : June 14, 2017
Last Update Posted : June 14, 2017
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Sponsor:
University of California, Los Angeles
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
James McCracken, University of California, Los Angeles
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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 Disorder With Hyperactivity |
Interventions |
Drug: Guanfacine Drug: Methylphenidate (MPH) |
Enrollment | 212 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
212 randomized (deemed eligible and enrolled). 71 randomized to Group 1: 3 dropped prior to receiving drug; thus 68 started drug. 70 randomized to Group 2: 1 dropped before receiving drug; thus 69 started drug. 71 randomized to Group 3:1 dropped before receiving drug; thus 70 started drug. |
Arm/Group Title | Group 1: Guan-Guan+Placebo | Group 2: Placebo-Placebo+DMPH | Group 3: Guan-Guan+DMPH |
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weeks 1-4: Guanfacine weeks 5-8: Guanfacine+Placebo | weeks 1-4: Placebo weeks 5-8: Placebo+DMPH | weeks 1-4: Guanfacine weeks 5-8: Guanfacine+DMPH (comb) |
Period Title: Overall Study | |||
Started | 68 | 69 | 70 |
Completed | 60 | 61 | 61 |
Not Completed | 8 | 8 | 9 |
Reason Not Completed | |||
Lost to Follow-up | 1 | 2 | 2 |
Physician Decision | 6 | 5 | 5 |
Adverse Event | 1 | 1 | 2 |
Baseline Characteristics
Arm/Group Title | Group 1: Guan-Guan+Placebo | Group 2: Placebo-Placebo+DMPH | Group 3: Guan-Guan+DMPH (Comb) | Total | |
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weeks 1-4: Guanfacine weeks 5-8: Guanfacine +Placebo | weeks 1-4: Placebo weeks 5-8: Placebo+DMPH | weeks 1-4: Guanfacine weeks 5-8: Guanfacine+DMPH (comb) | Total of all reporting groups | |
Overall Number of Baseline Participants | 68 | 69 | 70 | 207 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 68 participants | 69 participants | 70 participants | 207 participants | |
10.1 (2.1) | 10.1 (2.0) | 9.9 (2.2) | 10.0 (2.1) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 68 participants | 69 participants | 70 participants | 207 participants | |
Female |
23 33.8%
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23 33.3%
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19 27.1%
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65 31.4%
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Male |
45 66.2%
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46 66.7%
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51 72.9%
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142 68.6%
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Race/Ethnicity, Customized
[1] Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 68 participants | 69 participants | 70 participants | 207 participants |
White |
51 75.0%
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51 73.9%
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41 58.6%
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143 69.1%
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African American |
7 10.3%
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10 14.5%
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19 27.1%
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36 17.4%
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Asian, Pacific Islander |
7 10.3%
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4 5.8%
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5 7.1%
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16 7.7%
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Other |
3 4.4%
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4 5.8%
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5 7.1%
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12 5.8%
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Hispanic |
16 23.5%
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10 14.5%
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18 25.7%
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44 21.3%
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[1]
Measure Analysis Population Description: of the 212 participants randomized, 207 received at least one dose of study drug and form the safety and intent-to-treat samples.
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Outcome Measures
Adverse Events
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.
More Information
Results Point of Contact
Name/Title: | James T. McCracken, M.D. |
Organization: | University of California, Los Angeles |
Phone: | 310-825-0470 |
EMail: | jmccracken@mednet.ucla.edu |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | James McCracken, University of California, Los Angeles |
ClinicalTrials.gov Identifier: | NCT00429273 |
Other Study ID Numbers: |
P50MH077248-01 ( U.S. NIH Grant/Contract ) P50MH077248-01 ( U.S. NIH Grant/Contract ) DDTR B2-NDH 10-000453 ( Other Identifier: Office for Protection of Human Subjects ) |
First Submitted: | January 29, 2007 |
First Posted: | January 31, 2007 |
Results First Submitted: | January 18, 2017 |
Results First Posted: | June 14, 2017 |
Last Update Posted: | June 14, 2017 |