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
  Hide Participant Flow

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
  Hide Baseline Characteristics

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  
Number of Participants  
[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
  Show All Outcome Measures

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
  Hide 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
No text entered.


  More Information
  Hide More Information

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:

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