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Study of Atomoxetine and OROS Methylphenidate to Treat Children and Adolescents Ages 6-17 With ADHD
This study has been completed.
Study NCT00585910   Information provided by Massachusetts General Hospital

First Received on December 21, 2007.   Last Updated on January 3, 2011   History of Changes
Results First Received: September 22, 2009  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Attention Deficit Hyperactivity Disorder
Intervention: Drug: Atomoxetine and OROS Methylphenidate

  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
Subjects were recruited for this study from Outpatient Psychiatry Clinics, the Clinical Pediatric Psychopharmacology Unit of the MGH, and the MGH's extensive network of partnered institutions. Subjects were recruited from 2004 through 2007.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Some reasons as to why subjects were excluded from the trial before baselining include: being found ineligible, withdrawing consent, and being lost to follow-up.

Reporting Groups
  Description
Overall Study Atomoxetine (ATMX) treatment will be initiated and maintained for 4 weeks. If the subject is a partial responder to atomoxetine treatment, OROS methylphenidate (OROS MPH) will then be added to his or her treatment regimen for the final 3 weeks of the study. If the subject is not a partial responder to ATMX, they will end their study participation before entering into the ATMX + OROS MPH phase. Subjects already on ATMX before entering the study can enter directly into the OROS MPH phase of the study. 15 out of 55 completed Phase I only and 10 entered directly into Phase II.

Participant Flow for 2 periods

 Period 1:   Atomoxetine (ATMX) Alone
    Overall Study  
STARTED     72 [1]
COMPLETED     55 [2]
NOT COMPLETED     17  
[1] This is the number of subjects who were exposed to ATMX in Phase I of the study.
[2] Number of subjects who completed Phase I. 15 completed only Phase I. 40 proceeded onto Phase II.

Period 2:   ATMX + Osmotic-Release Methylphenidate
    Overall Study  
STARTED     50 [1]
COMPLETED     41  
NOT COMPLETED     9  
[1] Number of participants to add OROS MPH to their ATMX regimen



  Baseline Characteristics
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Reporting Groups
  Description
Overall Study Atomoxetine (ATMX) treatment will be initiated and maintained for 4 weeks. If the subject is a partial responder to atomoxetine treatment, OROS methylphenidate (OROS MPH) will then be added to his or her treatment regimen for the final 3 weeks of the study. If the subject is not a partial responder to ATMX, they will end their study participation before entering into the ATMX + OROS MPH phase. Subjects already on ATMX before entering the study can enter directly into the OROS MPH phase of the study. 15 out of 55 completed Phase I only and 10 entered directly into Phase II.

Baseline Measures
    Overall Study  
Number of Participants  
[units: participants]
 		  72  
Age  
[units: participants]
 		 
<=18 years     72  
Between 18 and 65 years     0  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation 		  9.1  ± 2.7  
Gender  
[units: participants]
 		 
Female     22  
Male     50  
Region of Enrollment  
[units: participants]
 		 
United States     72  



  Outcome Measures
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1.  Primary:   Attention Deficit Hyperactivity Disorder Rating Scale (ADHD RS)   [ Time Frame: 7 weeks ]
  Show Outcome Measure 1

2.  Secondary:   Clinical Global Impressions - Level of Severity (CGIs) for ADHD and Other Psychiatric Disorders   [ Time Frame: 7 weeks ]
  Show Outcome Measure 2


  Serious Adverse Events
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  Other Adverse Events
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  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.


Limitations and Caveats
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
  • Open trial so may have been biased;
  • Small sample size which may have underestimated findings;
  • Used a priori definition of partial response. However, our definition of ATMX partial responders has not been validated.
 


Results Point of Contact:  
Name/Title: Kerry Brodziak
Organization: Massachusetts General Hospital
phone: 617-503-1043
e-mail: kbrodziak@partners.org


No publications provided


Responsible Party: Timothy Wilens, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00585910     History of Changes
Other Study ID Numbers: 2003-P-002180
Study First Received: December 21, 2007
Results First Received: September 22, 2009
Last Updated: January 3, 2011
Health Authority: United States: Food and Drug Administration





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