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Methylphenidate Transdermal System (MTS) in the Treatment of Adult ADHD

This study has been completed.
Sponsor:
Collaborator:
Shire
Information provided by (Responsible Party):
frederick reimherr, University of Utah
ClinicalTrials.gov Identifier:
NCT00506285
First received: July 23, 2007
Last updated: January 15, 2015
Last verified: January 2015
Results First Received: October 19, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Attention Deficit Hyperactivity Disorder
Interventions: Drug: Methylphenidate Transdermal System (MTS)
Other: placebo patch

  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 (n=92) were recruited from 4-16-2007 through 10-24-2008. They were seen at the Psychiatry Research Clinic at the University of Utah School of Medicine.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There were 3 screening visits. Subjects met DSM-IV &/or Utah criteria for adult ADHD, experiencing at least moderate impairment. Most DSM-IV axis-I disorders were excluded. Of 92 subjects enrolled, 65 were randomized and produced double-blind data. The assessment procedure was more extensive than normal, leading to a high dropout rate.

Reporting Groups
  Description
A) MTS Arm Was 1st and PBO Arm Was 2nd MTS was initiated using a 12.5cm2 patch then increased to the highest possible tolerated dose within two weeks and held at that level for the final two weeks of the first 4-week arm. In the second double-blind arm subjects were started using a 12.5cm2 placebo patch, which was increased to the highest tolerated dose within two weeks and held at that level for the final two weeks of the second 4-week arm.
B) PBO Arm Was 1st and MTS Arm Was 2nd Placebo was initiated using a 12.5cm2 patch then increased to the highest possible tolerated dose within two weeks and held at that level for the final two weeks of the first 4-week arm. In the second double-blind arm subjects were started using a 12.5cm2 MTS patch, which was increased to the highest tolerated dose within two weeks and held at that level for the final two weeks of the second 4-week arm.

Participant Flow for 3 periods

Period 1:   3 Week Screening Phase
    A) MTS Arm Was 1st and PBO Arm Was 2nd   B) PBO Arm Was 1st and MTS Arm Was 2nd
STARTED   46   46 
COMPLETED   29   36 
NOT COMPLETED   17   10 
Withdrawal by Subject                17                10 

Period 2:   Double Blind Cross-Over Phase
    A) MTS Arm Was 1st and PBO Arm Was 2nd   B) PBO Arm Was 1st and MTS Arm Was 2nd
STARTED   29   36 
Received at Least 1 Dose MTS   29   31 
COMPLETED   20   31 
NOT COMPLETED   9   5 
Withdrawal by Subject                4                3 
Lost to Follow-up                5                2 

Period 3:   6-month Open Label Phase
    A) MTS Arm Was 1st and PBO Arm Was 2nd   B) PBO Arm Was 1st and MTS Arm Was 2nd
STARTED   20   31 
COMPLETED   10   19 
NOT COMPLETED   10   12 
Lost to Follow-up                1                7 
Withdrawal by Subject                9                5 



  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
a) Methylphenidate Transdermal System Was Taken First Subjects took Methylphenidate Transdermal System in the first treatment arm and placebo patch in the second treatment arm
B Placebo Patch Was Used First Placebo patch was used in the first treatment arm and MTS in the second treatment arm.
Total Total of all reporting groups

Baseline Measures
   a) Methylphenidate Transdermal System Was Taken First   B Placebo Patch Was Used First   Total 
Overall Participants Analyzed 
[Units: Participants]
 29   36   65 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   29   36   65 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 30.4  (9.5)   40.4  (11.8)   35.2  (11.8) 
Gender 
[Units: Participants]
     
Female   8   13   21 
Male   21   23   44 
Region of Enrollment 
[Units: Participants]
     
United States   29   36   65 
Wender-Reimherr Adult Attention Deficit Disorder Scale [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 21.5  (4.2)   21.3  (4.1)   21.4  (4.2) 
[1] This is a investigator rated scale of ADHD symptoms. It assessed the 7 domains of the Utah Criteria using scores of 0 (none) to 4 (highly symptomatic). Total possible scores range from 0 (no symptoms) to 28 (worst possible score).


  Outcome Measures
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1.  Primary:   Wender Reimherr Adult Attention Deficit Disorder Scale   [ Time Frame: Double-blind endpoints during MTS and placebo arms ]

2.  Secondary:   Conners' Adult ADHD Rating Scales (CAARS)   [ Time Frame: Double-blind endpoints for MTS and placebo arms ]


  Serious Adverse Events


  Other Adverse Events


  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
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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.


Results Point of Contact:  
Name/Title: Barrie K. Marchant
Organization: Psychiatry Research Clinic
phone: 801 585-6663
e-mail: barriemarchant@aol.com


Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: frederick reimherr, University of Utah
ClinicalTrials.gov Identifier: NCT00506285     History of Changes
Other Study ID Numbers: 20405
SPD485.420-Reimherr ( Other Grant/Funding Number: Shire Pharma )
Study First Received: July 23, 2007
Results First Received: October 19, 2012
Last Updated: January 15, 2015
Health Authority: United States: Institutional Review Board