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Single Versus Combination Medication Treatment for Children With Attention Deficit Hyperactivity Disorder (Project1)

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
James McCracken, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00429273
First received: January 29, 2007
Last updated: May 12, 2017
Last verified: May 2017
History of Changes
Results First Received: January 18, 2017  
Study Type: Interventional
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)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

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.

Reporting Groups
  Description
Group 1: Guan-Guan+Placebo weeks 1-4: Guanfacine weeks 5-8: Guanfacine+Placebo
Group 2: Placebo-Placebo+DMPH weeks 1-4: Placebo weeks 5-8: Placebo+DMPH
Group 3: Guan-Guan+DMPH weeks 1-4: Guanfacine weeks 5-8: Guanfacine+DMPH (comb)

Participant Flow:   Overall Study
    Group 1: Guan-Guan+Placebo   Group 2: Placebo-Placebo+DMPH   Group 3: Guan-Guan+DMPH
STARTED   68   69   70 
COMPLETED   60   61   61 
NOT COMPLETED   8   8   9 
Lost to Follow-up                1                2                2 
Physician Decision                6                5                5 
Adverse Event                1                1                2 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Group 1: Guan-Guan+Placebo weeks 1-4: Guanfacine weeks 5-8: Guanfacine +Placebo
Group 2: Placebo-Placebo+DMPH weeks 1-4: Placebo weeks 5-8: Placebo+DMPH
Group 3: Guan-Guan+DMPH (Comb) weeks 1-4: Guanfacine weeks 5-8: Guanfacine+DMPH (comb)
Total Total of all reporting groups

Baseline Measures
   Group 1: Guan-Guan+Placebo   Group 2: Placebo-Placebo+DMPH   Group 3: Guan-Guan+DMPH (Comb)   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 68   69   70   207 
Age 
[Units: Years]
Mean (Standard Deviation) 		 10.1  (2.1)   10.1  (2.0)   9.9  (2.2)   10.0  (2.1) 
Sex: Female, Male 
[Units: Participants]
Count of Participants 		       
Female      23  33.8%      23  33.3%      19  27.1%      65  31.4% 
Male      45  66.2%      46  66.7%      51  72.9%      142  68.6% 
Race/Ethnicity, Customized [1] 
[Units: Participants]
Count of Participants 		       
White   51   51   41   143 
African American   7   10   19   36 
Asian, Pacific Islander   7   4   5   16 
Other   3   4   5   12 
Hispanic   16   10   18   44 
[1] of the 212 participants randomized, 207 received at least one dose of study drug and form the safety and intent-to-treat samples.


  Outcome Measures

1.  Primary:   ADHD IV Rating Scale (Attention Deficit Hyperactivity Disorder Rating Scale)   [ Time Frame: Measured at baseline Week 4 and Week 8 ]
  Show Outcome Measure 1


  Serious Adverse Events
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  Other Adverse Events
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  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: James T. McCracken, M.D.
Organization: University of California, Los Angeles
phone: 310-825-0470
e-mail: 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     History of Changes
Other Study ID Numbers: P50MH077248-01 ( U.S. NIH Grant/Contract )
DDTR B2-NDH
10-000453 ( Other Identifier: Office for Protection of Human Subjects )
Study First Received: January 29, 2007
Results First Received: January 18, 2017
Last Updated: May 12, 2017